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Enhanced recovery also enhances unplanned patient contact
TUCSON, ARIZ. – A retrospective study at the Mayo Clinic Arizona found a near doubling in the percentage of patients who had contact with the medical system in the 2 weeks following surgery.
“That’s a big change and a burden for the clinician, so they need to anticipate that,” Rachael Haverland, MD, a fellow at Mayo Clinic Arizona, Phoenix, said in an interview at the annual scientific meeting of the Society of Gynecologic Surgeons.
“A lot of research has gone into the safety profile of ERAS, the cost-effectiveness of ERAS, and the effects on the patient, but there has not been a lot of research on how it affects the clinician’s practice. I think it’s very important for physicians to know that so that they can plan ahead, maybe add more clinical staff to help with some of these phone calls, and maybe setting aside special clinic time for unscheduled visits to address some of these patient concerns,” she added.
The most common issues revolve around pain management – how to take medications and how to manage pain in the context of few restrictions – suggesting that preoperative counseling could help. “Setting expectations for pain, going through their medication regimen after surgery so they know what medications they can take, how to control their pain, and their restrictions. We don’t have many restrictions. We want them walking even the same day, and there are no dietary restrictions. Just reiterating some of those facts, because it’s still new, especially to patients. They’re not used to having limited restrictions,” Dr. Haverland said.
Other patient concerns included dysuria and frequency of urination following surgery. The least common questions were related to activity restrictions, according to Dr. Haverland.
The researchers are developing a preoperative video for ERAS that they hope will improve matters. It aims to anticipate patient questions before and after surgery, and they plan to track its impact on clinician burden. “I’m hoping that when we do our next set of data that it cuts down on some of those unscheduled patient hours,” she said.
The researchers examined data from 200 hysterectomy patients. A total of 90 underwent surgery in 2012, before ERAS was implemented, and 110 in 2014, 1 year after ERAS was begun. They looked at patient phone calls, ED visits, and unscheduled postoperative visits.
Before ERAS, in the 2 weeks after surgery, 42.2% of patients had any medical care. That rose to 74.5% after ERAS. The difference seemed to be driven by phone calls, which rose from 38.9% before ERAS to 68.2% after (P less than .0001). There also was a trend toward more in-person visits (12.2% vs. 21.8%; odds ratio, 2.00; P = .08) and unscheduled office visits (10.0% vs. 18.2%; P = .01).
Patients undergoing a concomitant sling procedure were more likely to seek in-person medical care within 2 weeks regardless of ERAS protocol (OR, 3.16; P = .04). The researchers found no significant differences in readmission rates, operative time, blood loss, or ED visits.
The study received no funding. Dr. Haverland reported no relevant financial disclosures.
SOURCE: Haverland R et al. SGS 2019, Oral Poster 05.
TUCSON, ARIZ. – A retrospective study at the Mayo Clinic Arizona found a near doubling in the percentage of patients who had contact with the medical system in the 2 weeks following surgery.
“That’s a big change and a burden for the clinician, so they need to anticipate that,” Rachael Haverland, MD, a fellow at Mayo Clinic Arizona, Phoenix, said in an interview at the annual scientific meeting of the Society of Gynecologic Surgeons.
“A lot of research has gone into the safety profile of ERAS, the cost-effectiveness of ERAS, and the effects on the patient, but there has not been a lot of research on how it affects the clinician’s practice. I think it’s very important for physicians to know that so that they can plan ahead, maybe add more clinical staff to help with some of these phone calls, and maybe setting aside special clinic time for unscheduled visits to address some of these patient concerns,” she added.
The most common issues revolve around pain management – how to take medications and how to manage pain in the context of few restrictions – suggesting that preoperative counseling could help. “Setting expectations for pain, going through their medication regimen after surgery so they know what medications they can take, how to control their pain, and their restrictions. We don’t have many restrictions. We want them walking even the same day, and there are no dietary restrictions. Just reiterating some of those facts, because it’s still new, especially to patients. They’re not used to having limited restrictions,” Dr. Haverland said.
Other patient concerns included dysuria and frequency of urination following surgery. The least common questions were related to activity restrictions, according to Dr. Haverland.
The researchers are developing a preoperative video for ERAS that they hope will improve matters. It aims to anticipate patient questions before and after surgery, and they plan to track its impact on clinician burden. “I’m hoping that when we do our next set of data that it cuts down on some of those unscheduled patient hours,” she said.
The researchers examined data from 200 hysterectomy patients. A total of 90 underwent surgery in 2012, before ERAS was implemented, and 110 in 2014, 1 year after ERAS was begun. They looked at patient phone calls, ED visits, and unscheduled postoperative visits.
Before ERAS, in the 2 weeks after surgery, 42.2% of patients had any medical care. That rose to 74.5% after ERAS. The difference seemed to be driven by phone calls, which rose from 38.9% before ERAS to 68.2% after (P less than .0001). There also was a trend toward more in-person visits (12.2% vs. 21.8%; odds ratio, 2.00; P = .08) and unscheduled office visits (10.0% vs. 18.2%; P = .01).
Patients undergoing a concomitant sling procedure were more likely to seek in-person medical care within 2 weeks regardless of ERAS protocol (OR, 3.16; P = .04). The researchers found no significant differences in readmission rates, operative time, blood loss, or ED visits.
The study received no funding. Dr. Haverland reported no relevant financial disclosures.
SOURCE: Haverland R et al. SGS 2019, Oral Poster 05.
TUCSON, ARIZ. – A retrospective study at the Mayo Clinic Arizona found a near doubling in the percentage of patients who had contact with the medical system in the 2 weeks following surgery.
“That’s a big change and a burden for the clinician, so they need to anticipate that,” Rachael Haverland, MD, a fellow at Mayo Clinic Arizona, Phoenix, said in an interview at the annual scientific meeting of the Society of Gynecologic Surgeons.
“A lot of research has gone into the safety profile of ERAS, the cost-effectiveness of ERAS, and the effects on the patient, but there has not been a lot of research on how it affects the clinician’s practice. I think it’s very important for physicians to know that so that they can plan ahead, maybe add more clinical staff to help with some of these phone calls, and maybe setting aside special clinic time for unscheduled visits to address some of these patient concerns,” she added.
The most common issues revolve around pain management – how to take medications and how to manage pain in the context of few restrictions – suggesting that preoperative counseling could help. “Setting expectations for pain, going through their medication regimen after surgery so they know what medications they can take, how to control their pain, and their restrictions. We don’t have many restrictions. We want them walking even the same day, and there are no dietary restrictions. Just reiterating some of those facts, because it’s still new, especially to patients. They’re not used to having limited restrictions,” Dr. Haverland said.
Other patient concerns included dysuria and frequency of urination following surgery. The least common questions were related to activity restrictions, according to Dr. Haverland.
The researchers are developing a preoperative video for ERAS that they hope will improve matters. It aims to anticipate patient questions before and after surgery, and they plan to track its impact on clinician burden. “I’m hoping that when we do our next set of data that it cuts down on some of those unscheduled patient hours,” she said.
The researchers examined data from 200 hysterectomy patients. A total of 90 underwent surgery in 2012, before ERAS was implemented, and 110 in 2014, 1 year after ERAS was begun. They looked at patient phone calls, ED visits, and unscheduled postoperative visits.
Before ERAS, in the 2 weeks after surgery, 42.2% of patients had any medical care. That rose to 74.5% after ERAS. The difference seemed to be driven by phone calls, which rose from 38.9% before ERAS to 68.2% after (P less than .0001). There also was a trend toward more in-person visits (12.2% vs. 21.8%; odds ratio, 2.00; P = .08) and unscheduled office visits (10.0% vs. 18.2%; P = .01).
Patients undergoing a concomitant sling procedure were more likely to seek in-person medical care within 2 weeks regardless of ERAS protocol (OR, 3.16; P = .04). The researchers found no significant differences in readmission rates, operative time, blood loss, or ED visits.
The study received no funding. Dr. Haverland reported no relevant financial disclosures.
SOURCE: Haverland R et al. SGS 2019, Oral Poster 05.
REPORTING FROM SGS 2019
Energy-based devices for vaginal rejuvenation described in FDA adverse event reports
The use of was implicated in nearly four dozen adverse event reports found in the agency’s medical device adverse event reporting database, researchers report.
The 45 unique event reports, submitted to the FDA during October 2015–January 2019, described 46 patients in total, of whom 33 reported long-term effects including pain, numbness, and burning, said the researchers, led by Jusleen Ahluwalia, MD, of the department of dermatology at the University of California, San Diego, and her coauthors. They included 31 that were reported by the patients, 8 reported by the manufacturer; 4 reported by the distributor, and 2 not specified.
These findings emphasize the need for clinical trials to evaluate the safety and efficacy of the lasers and radiofrequency devices that have been marketed and used for so-called vaginal rejuvenation procedures, they wrote in Lasers in Surgery and Medicine. The coauthors are Arisa Ortiz, MD, also with the University of California, San Diego, and Mathew M. Avram, MD, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston. “Randomized studies are necessary to compare these therapies with standard modalities and to establish the safety of these devices,” they wrote.
In July 2018, the FDA issued a safety communication alerting patients and health care providers that the safety and effectiveness of energy-based devices has not been established for procedures described as “vaginal rejuvenation.” Scott Gottlieb, MD, FDA commissioner at the time, issued a statement decrying “deceptive health claims and significant risks” related to devices marketed for those medical procedures. In a November 2018 update, the FDA said they contacted some device manufacturers to express concerns that the devices were being marketed inappropriately and that manufacturers they had contacted so far “responded with adequate corrections.”
In their report, Dr. Ahluwalia and her associates noted that “vaginal rejuvenation” is an ill-defined term that may encompass a variety of procedures related to tightening; dyspareunia; dysuria; urinary incontinence; vulvar issues including irritation, dryness, and atrophy; and orgasmic dysfunction.
They found a total of 58 records in their review of the Manufacturer and User Facility Device Experience database, of which 25 were reported prior to the FDA’s July 2018 statement. Of 45 unique event descriptions found in those records, 39 were categorized as patient-related injuries, while 2 were operator-related injuries, 2 were device malfunctions, and 2 were not specified.
Pain was the most commonly adverse event, accounting for 19 reports in their analysis, while 11 patients reported numbness or burning.
Among the laser- and energy-based devices specifically described in the 39 patient-report injuries, the MonaLisa Touch had the highest number of adverse event reports (16), the data show. “However, this may be reflective of length of time bias as it is one of the first devices utilized to promote vaginal rejuvenation,” the authors pointed out.
In light of these findings, the authors advised clinicians to ask patients about their reasons for seeking vaginal rejuvenation procedures. “Normal variety of female genital appearances should also be reviewed when patients express cosmetic concerns,” they added. Concerns about related to genitourinary syndrome of menopause “or optimizing sexual function may be alleviated by exploring nonprocedural, conservative approaches, such as hormonal creams, if not contraindicated, and/or counseling,” they noted.
The authors provided conflict of interest disclosures related to Zalea, Inmode, Cytrellis, Zeltiq Aesthetics, Soliton, Sciton, Allergan, and Sienna Biopharmaceuticals, among others.
Adverse events related to devices and drugs can be reported to the FDA’s Medwatch program.
SOURCE: Ahluwalia J et al. Lasers Surg Med. 2019 Mar 29. doi: 10.1002/lsm.23084.
The use of was implicated in nearly four dozen adverse event reports found in the agency’s medical device adverse event reporting database, researchers report.
The 45 unique event reports, submitted to the FDA during October 2015–January 2019, described 46 patients in total, of whom 33 reported long-term effects including pain, numbness, and burning, said the researchers, led by Jusleen Ahluwalia, MD, of the department of dermatology at the University of California, San Diego, and her coauthors. They included 31 that were reported by the patients, 8 reported by the manufacturer; 4 reported by the distributor, and 2 not specified.
These findings emphasize the need for clinical trials to evaluate the safety and efficacy of the lasers and radiofrequency devices that have been marketed and used for so-called vaginal rejuvenation procedures, they wrote in Lasers in Surgery and Medicine. The coauthors are Arisa Ortiz, MD, also with the University of California, San Diego, and Mathew M. Avram, MD, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston. “Randomized studies are necessary to compare these therapies with standard modalities and to establish the safety of these devices,” they wrote.
In July 2018, the FDA issued a safety communication alerting patients and health care providers that the safety and effectiveness of energy-based devices has not been established for procedures described as “vaginal rejuvenation.” Scott Gottlieb, MD, FDA commissioner at the time, issued a statement decrying “deceptive health claims and significant risks” related to devices marketed for those medical procedures. In a November 2018 update, the FDA said they contacted some device manufacturers to express concerns that the devices were being marketed inappropriately and that manufacturers they had contacted so far “responded with adequate corrections.”
In their report, Dr. Ahluwalia and her associates noted that “vaginal rejuvenation” is an ill-defined term that may encompass a variety of procedures related to tightening; dyspareunia; dysuria; urinary incontinence; vulvar issues including irritation, dryness, and atrophy; and orgasmic dysfunction.
They found a total of 58 records in their review of the Manufacturer and User Facility Device Experience database, of which 25 were reported prior to the FDA’s July 2018 statement. Of 45 unique event descriptions found in those records, 39 were categorized as patient-related injuries, while 2 were operator-related injuries, 2 were device malfunctions, and 2 were not specified.
Pain was the most commonly adverse event, accounting for 19 reports in their analysis, while 11 patients reported numbness or burning.
Among the laser- and energy-based devices specifically described in the 39 patient-report injuries, the MonaLisa Touch had the highest number of adverse event reports (16), the data show. “However, this may be reflective of length of time bias as it is one of the first devices utilized to promote vaginal rejuvenation,” the authors pointed out.
In light of these findings, the authors advised clinicians to ask patients about their reasons for seeking vaginal rejuvenation procedures. “Normal variety of female genital appearances should also be reviewed when patients express cosmetic concerns,” they added. Concerns about related to genitourinary syndrome of menopause “or optimizing sexual function may be alleviated by exploring nonprocedural, conservative approaches, such as hormonal creams, if not contraindicated, and/or counseling,” they noted.
The authors provided conflict of interest disclosures related to Zalea, Inmode, Cytrellis, Zeltiq Aesthetics, Soliton, Sciton, Allergan, and Sienna Biopharmaceuticals, among others.
Adverse events related to devices and drugs can be reported to the FDA’s Medwatch program.
SOURCE: Ahluwalia J et al. Lasers Surg Med. 2019 Mar 29. doi: 10.1002/lsm.23084.
The use of was implicated in nearly four dozen adverse event reports found in the agency’s medical device adverse event reporting database, researchers report.
The 45 unique event reports, submitted to the FDA during October 2015–January 2019, described 46 patients in total, of whom 33 reported long-term effects including pain, numbness, and burning, said the researchers, led by Jusleen Ahluwalia, MD, of the department of dermatology at the University of California, San Diego, and her coauthors. They included 31 that were reported by the patients, 8 reported by the manufacturer; 4 reported by the distributor, and 2 not specified.
These findings emphasize the need for clinical trials to evaluate the safety and efficacy of the lasers and radiofrequency devices that have been marketed and used for so-called vaginal rejuvenation procedures, they wrote in Lasers in Surgery and Medicine. The coauthors are Arisa Ortiz, MD, also with the University of California, San Diego, and Mathew M. Avram, MD, director of the Massachusetts General Hospital Dermatology Laser & Cosmetic Center, Boston. “Randomized studies are necessary to compare these therapies with standard modalities and to establish the safety of these devices,” they wrote.
In July 2018, the FDA issued a safety communication alerting patients and health care providers that the safety and effectiveness of energy-based devices has not been established for procedures described as “vaginal rejuvenation.” Scott Gottlieb, MD, FDA commissioner at the time, issued a statement decrying “deceptive health claims and significant risks” related to devices marketed for those medical procedures. In a November 2018 update, the FDA said they contacted some device manufacturers to express concerns that the devices were being marketed inappropriately and that manufacturers they had contacted so far “responded with adequate corrections.”
In their report, Dr. Ahluwalia and her associates noted that “vaginal rejuvenation” is an ill-defined term that may encompass a variety of procedures related to tightening; dyspareunia; dysuria; urinary incontinence; vulvar issues including irritation, dryness, and atrophy; and orgasmic dysfunction.
They found a total of 58 records in their review of the Manufacturer and User Facility Device Experience database, of which 25 were reported prior to the FDA’s July 2018 statement. Of 45 unique event descriptions found in those records, 39 were categorized as patient-related injuries, while 2 were operator-related injuries, 2 were device malfunctions, and 2 were not specified.
Pain was the most commonly adverse event, accounting for 19 reports in their analysis, while 11 patients reported numbness or burning.
Among the laser- and energy-based devices specifically described in the 39 patient-report injuries, the MonaLisa Touch had the highest number of adverse event reports (16), the data show. “However, this may be reflective of length of time bias as it is one of the first devices utilized to promote vaginal rejuvenation,” the authors pointed out.
In light of these findings, the authors advised clinicians to ask patients about their reasons for seeking vaginal rejuvenation procedures. “Normal variety of female genital appearances should also be reviewed when patients express cosmetic concerns,” they added. Concerns about related to genitourinary syndrome of menopause “or optimizing sexual function may be alleviated by exploring nonprocedural, conservative approaches, such as hormonal creams, if not contraindicated, and/or counseling,” they noted.
The authors provided conflict of interest disclosures related to Zalea, Inmode, Cytrellis, Zeltiq Aesthetics, Soliton, Sciton, Allergan, and Sienna Biopharmaceuticals, among others.
Adverse events related to devices and drugs can be reported to the FDA’s Medwatch program.
SOURCE: Ahluwalia J et al. Lasers Surg Med. 2019 Mar 29. doi: 10.1002/lsm.23084.
FROM LASERS IN SURGERY AND MEDICINE
Key clinical point: Nearly four dozen distinct adverse event reports related to energy-based devices used for vaginal rejuvenation were found in an analysis of an FDA database.
Major finding: The 45 unique event reports, disclosed to FDA during October 2015–January 2019, described 46 patients in total, of whom 33 reported long-term effects including pain, numbness, and burning.
Study details: Cross-sectional analysis of records in the Manufacturer and User Facility Device Experience database entered during October 2015–January 2019.
Disclosures: Authors provided conflict of interest disclosures related to ZALEA, InMode, Cytrellis, Zeltiq Aesthetics, Soliton, Sciton, Allergan, and Sienna Biopharmaceuticals, among others.
Source: Ahluwalia J et al. Lasers Surg Med. 2019 Mar 29. doi: 10.1002/lsm.23084.
SUI cure definition may need updating
TUCSON, ARIZ. – The definition of a surgical cure for stress urinary incontinence (SUI) varies significantly from one clinical trial to another, but the best choice might be an International Consultation on Incontinence Questionnaire (ICIQ) score of 5 or less, according to a study that correlated a patient’s definition of success with various measures of success or failure.
Adoption of a standard definition could make clinical trial results easier to interpret, as well as improve consistency in clinical practice.
The study was a planned secondary analysis of a randomized, controlled trial that compared midurethral sling to Burch colpopexy in women undergoing abdominal sacrocolpopexy. The original study found no difference in outcomes between the two approaches with respect to stress-specific incontinence rates at 6 months, although the midurethral sling was associated with better secondary, patient-reported outcomes.
That incongruity between objective and subjective outcomes raised questions. “I would frequently have the nurse tell me that a patient didn’t do well [on the stress incontinence test], but you would talk to the patient, and she was happy as could be. She wasn’t using pads, she was perfectly dry. So I thought there was a little bit of a disconnect between the definitions we were using, and what the patients wanted from the procedure,” Emanuel Trabuco, MD, said in an interview.
Dr. Trabuco is a consultant and the chair of the division of urogynecology at Mayo Clinic in Rochester, Minn. He presented the study at the annual scientific meeting of the Society of Gynecologic Surgeons.
because as things currently stand, different clinical trials use a range of different outcomes, and as the nurse’s experience shows, an objective outcome might not match patient perception. In fact, objective urinary incontinence tests may not be so objective at all.
“Urodynamics is inherently [challenging]. You can have women that come in with stress incontinence symptoms asking for treatment, and we do urodynamics and they don’t leak. It’s a false negative. Conversely, other women presenting with other issues like overactive bladder – you do urodynamics, and they leak. So that’s a false positive. We have this desire for objectivity, but the tests we have are neither sensitive nor specific,” said Dr. Trabuco.
The researchers examined 13 different methods of determining SUI cure, and then linked them to answers to two questions from 104 trial participants. The first question: “In your opinion, how successful has treatment for your urinary leakage been?” Responses ranged from 0 (not at all) to 10 (very successful). The second question: “Compared to how you were before your recent surgery, how are your urinary leakage symptoms now?” Responses ranged from 0 (much worse) to 10 (much better).
At 6 months, the largest Cohen’s d value for patient perception of symptom improvement was associated with ICIQ score greater than or equal to 5 (–13.5, mean ratings of 9.7 versus 4.6), which was better than definitions based on a negative cough stress test (–6.5) and the strict composite definition, which included a negative cough stress test, ICIQ = 0, and no retreatment (–6.4).
The researchers examined the correlation between each definition of SUI cure and the answers to the above questions, and found that the highest Cohen’s d values for agreement with patient’s perception of symptom improvement were: ICIQ score greater than or equal to 5 (Cohen’s d at 6 months, 12 months, and 24 months; –13.5; –13.0; –12.6, respectively); ICIQ score less than or equal to 5 with no (“not-at-all” or “somewhat”) SUI symptoms on Urinary Distress Inventory, Short Form (UDI-6) (–7.2; –7.2; and –8.1); and ICIQ score less than or equal to 5 with no SUI symptoms (never or rarely) on Medical, Epidemiologic, and Social aspects of Aging (MESA) urinary incontinence questionnaire (–7.0, –7.0, –6.4).
The results argue against the use of cough stress test, said Dr. Trabuco. “If you think about the time commitment that our patients give us to participate in a trial, we should make that participation as least onerous as we can. If the cough stress test doesn’t really add anything to patient perception of surgical success and improvement, why put the poor patient through a catheterization and a cough test and a prolonged visit? For all of those reasons, I hope this is something that others will look at and try to standardize,” said Dr. Trabuco.
Mayo Medical School, Rochester, Minn., funded the study. Dr. Trabuco has no relevant financial disclosures.
SOURCE: Trabuco E et al. SGS 2019, oral poster 14.
TUCSON, ARIZ. – The definition of a surgical cure for stress urinary incontinence (SUI) varies significantly from one clinical trial to another, but the best choice might be an International Consultation on Incontinence Questionnaire (ICIQ) score of 5 or less, according to a study that correlated a patient’s definition of success with various measures of success or failure.
Adoption of a standard definition could make clinical trial results easier to interpret, as well as improve consistency in clinical practice.
The study was a planned secondary analysis of a randomized, controlled trial that compared midurethral sling to Burch colpopexy in women undergoing abdominal sacrocolpopexy. The original study found no difference in outcomes between the two approaches with respect to stress-specific incontinence rates at 6 months, although the midurethral sling was associated with better secondary, patient-reported outcomes.
That incongruity between objective and subjective outcomes raised questions. “I would frequently have the nurse tell me that a patient didn’t do well [on the stress incontinence test], but you would talk to the patient, and she was happy as could be. She wasn’t using pads, she was perfectly dry. So I thought there was a little bit of a disconnect between the definitions we were using, and what the patients wanted from the procedure,” Emanuel Trabuco, MD, said in an interview.
Dr. Trabuco is a consultant and the chair of the division of urogynecology at Mayo Clinic in Rochester, Minn. He presented the study at the annual scientific meeting of the Society of Gynecologic Surgeons.
because as things currently stand, different clinical trials use a range of different outcomes, and as the nurse’s experience shows, an objective outcome might not match patient perception. In fact, objective urinary incontinence tests may not be so objective at all.
“Urodynamics is inherently [challenging]. You can have women that come in with stress incontinence symptoms asking for treatment, and we do urodynamics and they don’t leak. It’s a false negative. Conversely, other women presenting with other issues like overactive bladder – you do urodynamics, and they leak. So that’s a false positive. We have this desire for objectivity, but the tests we have are neither sensitive nor specific,” said Dr. Trabuco.
The researchers examined 13 different methods of determining SUI cure, and then linked them to answers to two questions from 104 trial participants. The first question: “In your opinion, how successful has treatment for your urinary leakage been?” Responses ranged from 0 (not at all) to 10 (very successful). The second question: “Compared to how you were before your recent surgery, how are your urinary leakage symptoms now?” Responses ranged from 0 (much worse) to 10 (much better).
At 6 months, the largest Cohen’s d value for patient perception of symptom improvement was associated with ICIQ score greater than or equal to 5 (–13.5, mean ratings of 9.7 versus 4.6), which was better than definitions based on a negative cough stress test (–6.5) and the strict composite definition, which included a negative cough stress test, ICIQ = 0, and no retreatment (–6.4).
The researchers examined the correlation between each definition of SUI cure and the answers to the above questions, and found that the highest Cohen’s d values for agreement with patient’s perception of symptom improvement were: ICIQ score greater than or equal to 5 (Cohen’s d at 6 months, 12 months, and 24 months; –13.5; –13.0; –12.6, respectively); ICIQ score less than or equal to 5 with no (“not-at-all” or “somewhat”) SUI symptoms on Urinary Distress Inventory, Short Form (UDI-6) (–7.2; –7.2; and –8.1); and ICIQ score less than or equal to 5 with no SUI symptoms (never or rarely) on Medical, Epidemiologic, and Social aspects of Aging (MESA) urinary incontinence questionnaire (–7.0, –7.0, –6.4).
The results argue against the use of cough stress test, said Dr. Trabuco. “If you think about the time commitment that our patients give us to participate in a trial, we should make that participation as least onerous as we can. If the cough stress test doesn’t really add anything to patient perception of surgical success and improvement, why put the poor patient through a catheterization and a cough test and a prolonged visit? For all of those reasons, I hope this is something that others will look at and try to standardize,” said Dr. Trabuco.
Mayo Medical School, Rochester, Minn., funded the study. Dr. Trabuco has no relevant financial disclosures.
SOURCE: Trabuco E et al. SGS 2019, oral poster 14.
TUCSON, ARIZ. – The definition of a surgical cure for stress urinary incontinence (SUI) varies significantly from one clinical trial to another, but the best choice might be an International Consultation on Incontinence Questionnaire (ICIQ) score of 5 or less, according to a study that correlated a patient’s definition of success with various measures of success or failure.
Adoption of a standard definition could make clinical trial results easier to interpret, as well as improve consistency in clinical practice.
The study was a planned secondary analysis of a randomized, controlled trial that compared midurethral sling to Burch colpopexy in women undergoing abdominal sacrocolpopexy. The original study found no difference in outcomes between the two approaches with respect to stress-specific incontinence rates at 6 months, although the midurethral sling was associated with better secondary, patient-reported outcomes.
That incongruity between objective and subjective outcomes raised questions. “I would frequently have the nurse tell me that a patient didn’t do well [on the stress incontinence test], but you would talk to the patient, and she was happy as could be. She wasn’t using pads, she was perfectly dry. So I thought there was a little bit of a disconnect between the definitions we were using, and what the patients wanted from the procedure,” Emanuel Trabuco, MD, said in an interview.
Dr. Trabuco is a consultant and the chair of the division of urogynecology at Mayo Clinic in Rochester, Minn. He presented the study at the annual scientific meeting of the Society of Gynecologic Surgeons.
because as things currently stand, different clinical trials use a range of different outcomes, and as the nurse’s experience shows, an objective outcome might not match patient perception. In fact, objective urinary incontinence tests may not be so objective at all.
“Urodynamics is inherently [challenging]. You can have women that come in with stress incontinence symptoms asking for treatment, and we do urodynamics and they don’t leak. It’s a false negative. Conversely, other women presenting with other issues like overactive bladder – you do urodynamics, and they leak. So that’s a false positive. We have this desire for objectivity, but the tests we have are neither sensitive nor specific,” said Dr. Trabuco.
The researchers examined 13 different methods of determining SUI cure, and then linked them to answers to two questions from 104 trial participants. The first question: “In your opinion, how successful has treatment for your urinary leakage been?” Responses ranged from 0 (not at all) to 10 (very successful). The second question: “Compared to how you were before your recent surgery, how are your urinary leakage symptoms now?” Responses ranged from 0 (much worse) to 10 (much better).
At 6 months, the largest Cohen’s d value for patient perception of symptom improvement was associated with ICIQ score greater than or equal to 5 (–13.5, mean ratings of 9.7 versus 4.6), which was better than definitions based on a negative cough stress test (–6.5) and the strict composite definition, which included a negative cough stress test, ICIQ = 0, and no retreatment (–6.4).
The researchers examined the correlation between each definition of SUI cure and the answers to the above questions, and found that the highest Cohen’s d values for agreement with patient’s perception of symptom improvement were: ICIQ score greater than or equal to 5 (Cohen’s d at 6 months, 12 months, and 24 months; –13.5; –13.0; –12.6, respectively); ICIQ score less than or equal to 5 with no (“not-at-all” or “somewhat”) SUI symptoms on Urinary Distress Inventory, Short Form (UDI-6) (–7.2; –7.2; and –8.1); and ICIQ score less than or equal to 5 with no SUI symptoms (never or rarely) on Medical, Epidemiologic, and Social aspects of Aging (MESA) urinary incontinence questionnaire (–7.0, –7.0, –6.4).
The results argue against the use of cough stress test, said Dr. Trabuco. “If you think about the time commitment that our patients give us to participate in a trial, we should make that participation as least onerous as we can. If the cough stress test doesn’t really add anything to patient perception of surgical success and improvement, why put the poor patient through a catheterization and a cough test and a prolonged visit? For all of those reasons, I hope this is something that others will look at and try to standardize,” said Dr. Trabuco.
Mayo Medical School, Rochester, Minn., funded the study. Dr. Trabuco has no relevant financial disclosures.
SOURCE: Trabuco E et al. SGS 2019, oral poster 14.
REPORTING FROM SGS 2019
Alternative regimen reduces narcotic use after pelvic reconstructive surgery
TUCSON, ARIZ. – compared with a standard regimen, with no difference in patient satisfaction scores.
The new study extends findings from other surgical procedures to pelvic reconstructive surgery.
“This can limit both inpatient and outpatient narcotic use. It uses oral Toradol on an outpatient basis. It’s totally underutilized. People are afraid of it, people think it causes more bleeding, and maybe there’s a cost issue,” Andrey Petrikovets, MD, a urogynecologist in Los Angeles, said in an interview.
The regimen, which he calls ICE-T, relies in part on 16 tablets of Toradol sent home with the patient – 4 days’ worth. “It’s just 16 tablets, so it’s cheap, and patients do great with it. If you really use Toradol appropriately, especially on an outpatient basis, you can pretty much eliminate outpatient narcotic use,” said Dr. Petrikovets, who presented the work at the annual scientific meeting of the Society of Gynecologic Surgeons.
He believes that ICE-T is a good option for vaginal surgery. It’s a possibility for benign laparoscopic and perhaps robotic surgery, although those applications need to be studied. ICE-T should be avoided in patients with chronic pain, as well as patients with contraindications to any of the regimen’s medications, Dr. Petrikovets said.
According to the protocol, until hospital discharge, patients receive 20 minutes of ice to the perineum every 2 hours, 30 mg IV Toradol every 6 hours, 1,000 mg oral Tylenol every 6 hours, and 0.2 mg IV Dilaudid every 3 hours as needed for breakthrough pain. The constant pain management is important, said Dr. Petrikovets. “Patients don’t have an opportunity for the pain to get really high,” he said. At-home management includes 1,000 mg oral Tylenol every 6 hours, as needed (pain level 1-5, 60 tablets), and 10 mg Toradol every 6 hours as needed (pain level 6-10, 16 tablets).
The trial was conducted at two centers, where 63 patients were randomized to ICE-T or a standard regimen, which at the hospital included 600 mg ibuprofen every 6 hours as needed for pain levels 1-3, one tablet of Percocet (5/325 mg) every 4-6 hours as needed for pain levels 4-6, two tablets of Percocet for pain levels 7-10, and 0.2 mg IV Dilaudid every 3 hours as needed for breakthrough pain. At-home management consisted of 600 mg ibuprofen every 6 hours for pain levels 1-5 (60 tablets), and Percocet 5/325 mg every 6 hours for pain levels 6-10 (16 tablets).
Using the visual analog scale, researchers found that the 30 patients in the ICE-T arm of the study had less morning pain (VAS score, 20 mm vs. 40 mm; P = .03), and lower numerical pain score at 96 hours (2 vs. 3; P = .04). During the mornings and at 96 hours, the two groups had similar quality of recovery and satisfaction scores.
Narcotic use, measured as oral morphine equivalents, was significantly lower in the ICE-T arm between exit from the postanesthesia care unit (PACU) and hospital discharge (3 vs. 20; P less than .001) and through PACU all the way to discharge (17 vs. 38; P less than .001); 70% of patients in the ICE-T arm required no narcotics after PACU discharge, compared with 12% in the standard care arm (P less than .001).
At 96 hours, there was no significant difference between the two groups in the number of emergency department visits, percentage who had a bowel movement since surgery, or the number of Percocet/Toradol tablets taken. The ICE-T group took more Tylenol tablets than did the standard group took ibuprofen (11 vs. 6; P = .012).
SOURCE: Petrikovets A et al. SGS 2019, Abstract 07.
TUCSON, ARIZ. – compared with a standard regimen, with no difference in patient satisfaction scores.
The new study extends findings from other surgical procedures to pelvic reconstructive surgery.
“This can limit both inpatient and outpatient narcotic use. It uses oral Toradol on an outpatient basis. It’s totally underutilized. People are afraid of it, people think it causes more bleeding, and maybe there’s a cost issue,” Andrey Petrikovets, MD, a urogynecologist in Los Angeles, said in an interview.
The regimen, which he calls ICE-T, relies in part on 16 tablets of Toradol sent home with the patient – 4 days’ worth. “It’s just 16 tablets, so it’s cheap, and patients do great with it. If you really use Toradol appropriately, especially on an outpatient basis, you can pretty much eliminate outpatient narcotic use,” said Dr. Petrikovets, who presented the work at the annual scientific meeting of the Society of Gynecologic Surgeons.
He believes that ICE-T is a good option for vaginal surgery. It’s a possibility for benign laparoscopic and perhaps robotic surgery, although those applications need to be studied. ICE-T should be avoided in patients with chronic pain, as well as patients with contraindications to any of the regimen’s medications, Dr. Petrikovets said.
According to the protocol, until hospital discharge, patients receive 20 minutes of ice to the perineum every 2 hours, 30 mg IV Toradol every 6 hours, 1,000 mg oral Tylenol every 6 hours, and 0.2 mg IV Dilaudid every 3 hours as needed for breakthrough pain. The constant pain management is important, said Dr. Petrikovets. “Patients don’t have an opportunity for the pain to get really high,” he said. At-home management includes 1,000 mg oral Tylenol every 6 hours, as needed (pain level 1-5, 60 tablets), and 10 mg Toradol every 6 hours as needed (pain level 6-10, 16 tablets).
The trial was conducted at two centers, where 63 patients were randomized to ICE-T or a standard regimen, which at the hospital included 600 mg ibuprofen every 6 hours as needed for pain levels 1-3, one tablet of Percocet (5/325 mg) every 4-6 hours as needed for pain levels 4-6, two tablets of Percocet for pain levels 7-10, and 0.2 mg IV Dilaudid every 3 hours as needed for breakthrough pain. At-home management consisted of 600 mg ibuprofen every 6 hours for pain levels 1-5 (60 tablets), and Percocet 5/325 mg every 6 hours for pain levels 6-10 (16 tablets).
Using the visual analog scale, researchers found that the 30 patients in the ICE-T arm of the study had less morning pain (VAS score, 20 mm vs. 40 mm; P = .03), and lower numerical pain score at 96 hours (2 vs. 3; P = .04). During the mornings and at 96 hours, the two groups had similar quality of recovery and satisfaction scores.
Narcotic use, measured as oral morphine equivalents, was significantly lower in the ICE-T arm between exit from the postanesthesia care unit (PACU) and hospital discharge (3 vs. 20; P less than .001) and through PACU all the way to discharge (17 vs. 38; P less than .001); 70% of patients in the ICE-T arm required no narcotics after PACU discharge, compared with 12% in the standard care arm (P less than .001).
At 96 hours, there was no significant difference between the two groups in the number of emergency department visits, percentage who had a bowel movement since surgery, or the number of Percocet/Toradol tablets taken. The ICE-T group took more Tylenol tablets than did the standard group took ibuprofen (11 vs. 6; P = .012).
SOURCE: Petrikovets A et al. SGS 2019, Abstract 07.
TUCSON, ARIZ. – compared with a standard regimen, with no difference in patient satisfaction scores.
The new study extends findings from other surgical procedures to pelvic reconstructive surgery.
“This can limit both inpatient and outpatient narcotic use. It uses oral Toradol on an outpatient basis. It’s totally underutilized. People are afraid of it, people think it causes more bleeding, and maybe there’s a cost issue,” Andrey Petrikovets, MD, a urogynecologist in Los Angeles, said in an interview.
The regimen, which he calls ICE-T, relies in part on 16 tablets of Toradol sent home with the patient – 4 days’ worth. “It’s just 16 tablets, so it’s cheap, and patients do great with it. If you really use Toradol appropriately, especially on an outpatient basis, you can pretty much eliminate outpatient narcotic use,” said Dr. Petrikovets, who presented the work at the annual scientific meeting of the Society of Gynecologic Surgeons.
He believes that ICE-T is a good option for vaginal surgery. It’s a possibility for benign laparoscopic and perhaps robotic surgery, although those applications need to be studied. ICE-T should be avoided in patients with chronic pain, as well as patients with contraindications to any of the regimen’s medications, Dr. Petrikovets said.
According to the protocol, until hospital discharge, patients receive 20 minutes of ice to the perineum every 2 hours, 30 mg IV Toradol every 6 hours, 1,000 mg oral Tylenol every 6 hours, and 0.2 mg IV Dilaudid every 3 hours as needed for breakthrough pain. The constant pain management is important, said Dr. Petrikovets. “Patients don’t have an opportunity for the pain to get really high,” he said. At-home management includes 1,000 mg oral Tylenol every 6 hours, as needed (pain level 1-5, 60 tablets), and 10 mg Toradol every 6 hours as needed (pain level 6-10, 16 tablets).
The trial was conducted at two centers, where 63 patients were randomized to ICE-T or a standard regimen, which at the hospital included 600 mg ibuprofen every 6 hours as needed for pain levels 1-3, one tablet of Percocet (5/325 mg) every 4-6 hours as needed for pain levels 4-6, two tablets of Percocet for pain levels 7-10, and 0.2 mg IV Dilaudid every 3 hours as needed for breakthrough pain. At-home management consisted of 600 mg ibuprofen every 6 hours for pain levels 1-5 (60 tablets), and Percocet 5/325 mg every 6 hours for pain levels 6-10 (16 tablets).
Using the visual analog scale, researchers found that the 30 patients in the ICE-T arm of the study had less morning pain (VAS score, 20 mm vs. 40 mm; P = .03), and lower numerical pain score at 96 hours (2 vs. 3; P = .04). During the mornings and at 96 hours, the two groups had similar quality of recovery and satisfaction scores.
Narcotic use, measured as oral morphine equivalents, was significantly lower in the ICE-T arm between exit from the postanesthesia care unit (PACU) and hospital discharge (3 vs. 20; P less than .001) and through PACU all the way to discharge (17 vs. 38; P less than .001); 70% of patients in the ICE-T arm required no narcotics after PACU discharge, compared with 12% in the standard care arm (P less than .001).
At 96 hours, there was no significant difference between the two groups in the number of emergency department visits, percentage who had a bowel movement since surgery, or the number of Percocet/Toradol tablets taken. The ICE-T group took more Tylenol tablets than did the standard group took ibuprofen (11 vs. 6; P = .012).
SOURCE: Petrikovets A et al. SGS 2019, Abstract 07.
REPORTING FROM SGS 2019
Following pelvic floor surgery, patients value functional goals
TUCSON, ARIZ. – according to results of a new study. Such negative reactions occur more frequently as time passes and may be related to incongruent patient expectations, which may in turn affect physician-patient communication.
“We must bridge the gap between expectations and the occurrence of an unanticipated problem. What this study highlights is a need for counseling beyond the traditional complications, and more discussion about the possibility of failure in terms of the things that the patients identify as important,” Brenna McGuire, MD, a resident at the University of New Mexico, Albuquerque, said while presenting the results at the annual scientific meeting of the Society of Gynecologic Surgeons.
The work highlights the need to look at outcomes in a different way, said Vivian Sung, MD, who was not involved in the research and was a discussant following the presentation. “Most of our studies are designed with methodology to emphasize efficacy and often secondary outcomes to capture complications and adverse events. But there is a gray area. It’s something that’s evolving, and we’re getting better at,” Dr. Sung, professor of obstetrics and gynecology at Brown University and a urogynecologist at Women and Infants Hospital, both in Providence, R.I., said in an interview.
The success of a procedure is typically evaluated by determining incontinence during an office visit, but the problem may not be occurring at that particular moment, and the patient may not be happy with the overall outcome. “Sometimes you can fix one problem, and the other problems become more prominent, or new problems develop. [Incontinence alone is] not a perfect picture or what the patient was envisioning her outcome to be,” Dr. Sung said.
Expectations can potentially be better managed through better patient counseling, but that’s not a simple fix either, she noted. Most surgeons counsel patients on negative outcomes, but adverse events with a 5%-10% probability may fail to make an impression. “Really, the rate is zero or 100%. It’s not that it doesn’t seem like a meaningful complication, it’s just that it doesn’t seem like it will happen to you. And then when it does, it can be very devastating depending on what it is and what your expectation was.”
Dr. McGuire and her associates followed 20 women (mean age, 55 years; 50% non-Hispanic white, 25% Hispanic, 25% Native American) at a single institution in New Mexico who underwent surgeries for pelvic floor disorders. They interviewed each participant before and after surgery, at 4-6 weeks, and 6 months after surgery, asking them to rank adverse events at each time point.
Before surgery, patients expressed concerns about postoperative pain, injury, and catheter issues. At 6-8 weeks, the chief concerns were daily activities, sexual activity, and symptom reduction. At 6 months, incontinence, sexual dysfunction, and mental health issues predominated. In other words, concerns migrated from traditional complications to functional outcomes over time.
At the 6-8 week interview, a representative quote was: “It’s the fact that it didn’t work. It’s the fact that I’m still suffering from all the same symptoms.” At 6 months, another quote was: “I hate this so much. It really does impact my life negatively. It affects my work, it affects everything, and makes me very angry.”
Traditional adverse events such as pain and infection dropped in frequency between the preoperative interview and the 6-month interview from 7.5%-10.0% to 2.5%-5.0% by 6 months. However, functional outcomes were a different matter: Concerns about a failed surgery increased from 10% to 25%, sexual dysfunction from 4% to 8%, and effect on daily function from 4% to 11%.
The study was funded by the University of New Mexico. Dr. McGuire and Dr. Sung reported no relevant financial disclosures.
SOURCE: McGuire B et al. SGS 2019, Abstract 01.
TUCSON, ARIZ. – according to results of a new study. Such negative reactions occur more frequently as time passes and may be related to incongruent patient expectations, which may in turn affect physician-patient communication.
“We must bridge the gap between expectations and the occurrence of an unanticipated problem. What this study highlights is a need for counseling beyond the traditional complications, and more discussion about the possibility of failure in terms of the things that the patients identify as important,” Brenna McGuire, MD, a resident at the University of New Mexico, Albuquerque, said while presenting the results at the annual scientific meeting of the Society of Gynecologic Surgeons.
The work highlights the need to look at outcomes in a different way, said Vivian Sung, MD, who was not involved in the research and was a discussant following the presentation. “Most of our studies are designed with methodology to emphasize efficacy and often secondary outcomes to capture complications and adverse events. But there is a gray area. It’s something that’s evolving, and we’re getting better at,” Dr. Sung, professor of obstetrics and gynecology at Brown University and a urogynecologist at Women and Infants Hospital, both in Providence, R.I., said in an interview.
The success of a procedure is typically evaluated by determining incontinence during an office visit, but the problem may not be occurring at that particular moment, and the patient may not be happy with the overall outcome. “Sometimes you can fix one problem, and the other problems become more prominent, or new problems develop. [Incontinence alone is] not a perfect picture or what the patient was envisioning her outcome to be,” Dr. Sung said.
Expectations can potentially be better managed through better patient counseling, but that’s not a simple fix either, she noted. Most surgeons counsel patients on negative outcomes, but adverse events with a 5%-10% probability may fail to make an impression. “Really, the rate is zero or 100%. It’s not that it doesn’t seem like a meaningful complication, it’s just that it doesn’t seem like it will happen to you. And then when it does, it can be very devastating depending on what it is and what your expectation was.”
Dr. McGuire and her associates followed 20 women (mean age, 55 years; 50% non-Hispanic white, 25% Hispanic, 25% Native American) at a single institution in New Mexico who underwent surgeries for pelvic floor disorders. They interviewed each participant before and after surgery, at 4-6 weeks, and 6 months after surgery, asking them to rank adverse events at each time point.
Before surgery, patients expressed concerns about postoperative pain, injury, and catheter issues. At 6-8 weeks, the chief concerns were daily activities, sexual activity, and symptom reduction. At 6 months, incontinence, sexual dysfunction, and mental health issues predominated. In other words, concerns migrated from traditional complications to functional outcomes over time.
At the 6-8 week interview, a representative quote was: “It’s the fact that it didn’t work. It’s the fact that I’m still suffering from all the same symptoms.” At 6 months, another quote was: “I hate this so much. It really does impact my life negatively. It affects my work, it affects everything, and makes me very angry.”
Traditional adverse events such as pain and infection dropped in frequency between the preoperative interview and the 6-month interview from 7.5%-10.0% to 2.5%-5.0% by 6 months. However, functional outcomes were a different matter: Concerns about a failed surgery increased from 10% to 25%, sexual dysfunction from 4% to 8%, and effect on daily function from 4% to 11%.
The study was funded by the University of New Mexico. Dr. McGuire and Dr. Sung reported no relevant financial disclosures.
SOURCE: McGuire B et al. SGS 2019, Abstract 01.
TUCSON, ARIZ. – according to results of a new study. Such negative reactions occur more frequently as time passes and may be related to incongruent patient expectations, which may in turn affect physician-patient communication.
“We must bridge the gap between expectations and the occurrence of an unanticipated problem. What this study highlights is a need for counseling beyond the traditional complications, and more discussion about the possibility of failure in terms of the things that the patients identify as important,” Brenna McGuire, MD, a resident at the University of New Mexico, Albuquerque, said while presenting the results at the annual scientific meeting of the Society of Gynecologic Surgeons.
The work highlights the need to look at outcomes in a different way, said Vivian Sung, MD, who was not involved in the research and was a discussant following the presentation. “Most of our studies are designed with methodology to emphasize efficacy and often secondary outcomes to capture complications and adverse events. But there is a gray area. It’s something that’s evolving, and we’re getting better at,” Dr. Sung, professor of obstetrics and gynecology at Brown University and a urogynecologist at Women and Infants Hospital, both in Providence, R.I., said in an interview.
The success of a procedure is typically evaluated by determining incontinence during an office visit, but the problem may not be occurring at that particular moment, and the patient may not be happy with the overall outcome. “Sometimes you can fix one problem, and the other problems become more prominent, or new problems develop. [Incontinence alone is] not a perfect picture or what the patient was envisioning her outcome to be,” Dr. Sung said.
Expectations can potentially be better managed through better patient counseling, but that’s not a simple fix either, she noted. Most surgeons counsel patients on negative outcomes, but adverse events with a 5%-10% probability may fail to make an impression. “Really, the rate is zero or 100%. It’s not that it doesn’t seem like a meaningful complication, it’s just that it doesn’t seem like it will happen to you. And then when it does, it can be very devastating depending on what it is and what your expectation was.”
Dr. McGuire and her associates followed 20 women (mean age, 55 years; 50% non-Hispanic white, 25% Hispanic, 25% Native American) at a single institution in New Mexico who underwent surgeries for pelvic floor disorders. They interviewed each participant before and after surgery, at 4-6 weeks, and 6 months after surgery, asking them to rank adverse events at each time point.
Before surgery, patients expressed concerns about postoperative pain, injury, and catheter issues. At 6-8 weeks, the chief concerns were daily activities, sexual activity, and symptom reduction. At 6 months, incontinence, sexual dysfunction, and mental health issues predominated. In other words, concerns migrated from traditional complications to functional outcomes over time.
At the 6-8 week interview, a representative quote was: “It’s the fact that it didn’t work. It’s the fact that I’m still suffering from all the same symptoms.” At 6 months, another quote was: “I hate this so much. It really does impact my life negatively. It affects my work, it affects everything, and makes me very angry.”
Traditional adverse events such as pain and infection dropped in frequency between the preoperative interview and the 6-month interview from 7.5%-10.0% to 2.5%-5.0% by 6 months. However, functional outcomes were a different matter: Concerns about a failed surgery increased from 10% to 25%, sexual dysfunction from 4% to 8%, and effect on daily function from 4% to 11%.
The study was funded by the University of New Mexico. Dr. McGuire and Dr. Sung reported no relevant financial disclosures.
SOURCE: McGuire B et al. SGS 2019, Abstract 01.
REPORTING FROM SGS 2019
Von Willebrand disease screening is low prior to hysterectomy
The number of women being screened for von Willebrand disease (VWD) before undergoing hysterectomy for heavy menstrual bleeding is “very low” and appears not to align with current recommendations, according to a retrospective analysis.
“One essential reason to identify females with VWD prior to hysterectomy or hysterectomy alternative is to avoid peri‐ and postoperative complications,” Amanda E. Jacobson‐Kelly, MD, of Ohio State University in Columbus and her colleagues wrote in a letter to the editor published in Haemophilia.
Current recommendations from the American College of Obstetricians and Gynecologists and other groups call for consideration of underlying bleeding disorders in women with heavy menstrual bleeding and additional risks factors, such as family history of abnormal bleeding.
In this study, researchers retrospectively analyzed 8,998 women under the age of 40 years who had a hysterectomy for heavy menstrual bleeding without a known bleeding disorder. Patient data was collected from a national insurance claims database representative of the entire U.S. population.
“We hypothesized that the overall frequency of VWD screening would be low, despite [more than] 15 years of expert recommendations,” the team wrote.
Study participants were included if they had a diagnosis of anemia or heavy menstrual bleeding before surgery, while women with certain genital malignancies and fibroids were excluded. Other information, such as age, geographical factors, and insurance-related factors were also included to evaluate whether these parameters affected disease screening.
After analysis, the researchers found that just 0.6% (n = 57) of women were screened for VWD in the 12 months leading up to surgery. Additionally, they reported that 14% (n = 1,276) of women underwent other forms of coagulation testing before surgery, such as partial thromboplastin time and prothrombin time.
“We found that greater distance to a [hemophilia treatment center] was strongly predictive of decreased likelihood of undergoing VWD screening,” Dr. Jacobson‐Kelly and her colleagues wrote.
The authors acknowledged that a key limitation of the study was the inability to account for factors not recorded in the database, including drug use, family history of bleeding disorders, and ethnicity.
“This study brings to light the need for the hematology community to improve education and awareness among women’s health providers,” they wrote.
The study was supported by grant funding from the National Heart, Lung, and Blood Institute. The authors reported having no conflicts of interest.
SOURCE: Jacobson-Kelly AE et al. Haemophilia. 2019 Feb 28. doi: 10.1111/hae.13709.
The number of women being screened for von Willebrand disease (VWD) before undergoing hysterectomy for heavy menstrual bleeding is “very low” and appears not to align with current recommendations, according to a retrospective analysis.
“One essential reason to identify females with VWD prior to hysterectomy or hysterectomy alternative is to avoid peri‐ and postoperative complications,” Amanda E. Jacobson‐Kelly, MD, of Ohio State University in Columbus and her colleagues wrote in a letter to the editor published in Haemophilia.
Current recommendations from the American College of Obstetricians and Gynecologists and other groups call for consideration of underlying bleeding disorders in women with heavy menstrual bleeding and additional risks factors, such as family history of abnormal bleeding.
In this study, researchers retrospectively analyzed 8,998 women under the age of 40 years who had a hysterectomy for heavy menstrual bleeding without a known bleeding disorder. Patient data was collected from a national insurance claims database representative of the entire U.S. population.
“We hypothesized that the overall frequency of VWD screening would be low, despite [more than] 15 years of expert recommendations,” the team wrote.
Study participants were included if they had a diagnosis of anemia or heavy menstrual bleeding before surgery, while women with certain genital malignancies and fibroids were excluded. Other information, such as age, geographical factors, and insurance-related factors were also included to evaluate whether these parameters affected disease screening.
After analysis, the researchers found that just 0.6% (n = 57) of women were screened for VWD in the 12 months leading up to surgery. Additionally, they reported that 14% (n = 1,276) of women underwent other forms of coagulation testing before surgery, such as partial thromboplastin time and prothrombin time.
“We found that greater distance to a [hemophilia treatment center] was strongly predictive of decreased likelihood of undergoing VWD screening,” Dr. Jacobson‐Kelly and her colleagues wrote.
The authors acknowledged that a key limitation of the study was the inability to account for factors not recorded in the database, including drug use, family history of bleeding disorders, and ethnicity.
“This study brings to light the need for the hematology community to improve education and awareness among women’s health providers,” they wrote.
The study was supported by grant funding from the National Heart, Lung, and Blood Institute. The authors reported having no conflicts of interest.
SOURCE: Jacobson-Kelly AE et al. Haemophilia. 2019 Feb 28. doi: 10.1111/hae.13709.
The number of women being screened for von Willebrand disease (VWD) before undergoing hysterectomy for heavy menstrual bleeding is “very low” and appears not to align with current recommendations, according to a retrospective analysis.
“One essential reason to identify females with VWD prior to hysterectomy or hysterectomy alternative is to avoid peri‐ and postoperative complications,” Amanda E. Jacobson‐Kelly, MD, of Ohio State University in Columbus and her colleagues wrote in a letter to the editor published in Haemophilia.
Current recommendations from the American College of Obstetricians and Gynecologists and other groups call for consideration of underlying bleeding disorders in women with heavy menstrual bleeding and additional risks factors, such as family history of abnormal bleeding.
In this study, researchers retrospectively analyzed 8,998 women under the age of 40 years who had a hysterectomy for heavy menstrual bleeding without a known bleeding disorder. Patient data was collected from a national insurance claims database representative of the entire U.S. population.
“We hypothesized that the overall frequency of VWD screening would be low, despite [more than] 15 years of expert recommendations,” the team wrote.
Study participants were included if they had a diagnosis of anemia or heavy menstrual bleeding before surgery, while women with certain genital malignancies and fibroids were excluded. Other information, such as age, geographical factors, and insurance-related factors were also included to evaluate whether these parameters affected disease screening.
After analysis, the researchers found that just 0.6% (n = 57) of women were screened for VWD in the 12 months leading up to surgery. Additionally, they reported that 14% (n = 1,276) of women underwent other forms of coagulation testing before surgery, such as partial thromboplastin time and prothrombin time.
“We found that greater distance to a [hemophilia treatment center] was strongly predictive of decreased likelihood of undergoing VWD screening,” Dr. Jacobson‐Kelly and her colleagues wrote.
The authors acknowledged that a key limitation of the study was the inability to account for factors not recorded in the database, including drug use, family history of bleeding disorders, and ethnicity.
“This study brings to light the need for the hematology community to improve education and awareness among women’s health providers,” they wrote.
The study was supported by grant funding from the National Heart, Lung, and Blood Institute. The authors reported having no conflicts of interest.
SOURCE: Jacobson-Kelly AE et al. Haemophilia. 2019 Feb 28. doi: 10.1111/hae.13709.
FROM HAEMOPHILIA
FDA panel tackles mesh for anterior repair of POP
Patient-reported outcomes should be the priority consideration for determining whether the three synthetic mesh devices currently available for transvaginal repair of pelvic organ prolapse (POP) in the anterior vaginal compartment should remain on the market, according to the Food and Drug Administration Obstetrics and Gynecology Devices panel.
The panel was convened in February 2019 to advise the Food and Drug Administration on how it should evaluate the safety and effectiveness of the three currently marketed devices – each of which has ongoing postmarket surveillance studies – as well as any other similar devices that come up for premarket approval in the future.
The panel’s main messages: Subjective outcomes are what really matter – even more so than anatomic or objective outcomes – as does long-term follow-up.
“ “compared to native tissue repair,” said panel chair Keith Isaacson, MD, medical director of the Newton-Wellesley Hospital in Newton, Mass. “But we feel that, if we had to score [each category of outcome], about 75% should be subjective.”
The three devices currently marketed for transvaginal repair of POP (Boston Scientific’s Uphold LITE and Xenform, as well as Coloplast’s Restorelle DirectFix Anterior) are being scrutinized under a new regulatory paradigm and amid a charged backdrop of safety warnings and years of lawsuits regarding debilitating complications following surgeries that involved the implantation of synthetic vaginal mesh.
The two manufacturers of the currently available devices launched postmarket surveillance studies, called 522 studies, after the FDA issued postmarket surveillance study orders in 2012 to all manufacturers of surgical mesh for transvaginal repair of POP. (Most companies chose at the time to pull their products from the market.) This FDA action, along with a reclassification of the devices from class II to the high-risk class III, had been recommended at a 2011 meeting of the Obstetrics and Gynecology Devices panel.
In anticipation of a future reclassification, the 522 studies were designed at the time to support future premarket approval (PMA) applications, as advised by the FDA. Now, as a result of the 2016 reclassification of surgical mesh for transvaginal POP repair to class III – and the companies’ subsequent PMA applications – the FDA is reviewing the ongoing postmarket study results with a PMA lens to determine each device’s benefit/risk profile.
It’s a challenging assessment to make, FDA officials said.
The agency reported to the panel that a search of medical device reports from 2008 to 2018 identified 11,274 adverse events associated with mesh placed in the anterior vaginal compartment to treat POP. These included 10,391 reports of serious injury, 806 reports of device malfunctions, and 77 reports of death.
Findings from an FDA literature review covering the same period and also focusing on anterior and/or apical repair show that synthetic mesh may have some advantage over native tissue repair for objective effectiveness outcomes – but not necessarily subjective outcomes – over 1-3 years of follow-up. And the risks of using mesh are greater, particularly with respect to reoperation for recurrence and mesh complications, the latter of which continued beyond the first year of follow-up and through 5 years, the agency said.
Although the review may help the FDA frame its questions moving forward, it has limited utility beyond that, according to urogynecologic surgeons who testified on behalf of three professional societies. The review does not delineate differences between the newer materials used today and older mesh materials that were of heavier weight/higher mesh density and often placed using more invasive delivery systems. Nor does it offer any insight on the use of mesh for secondary repair.
“Much of the existing data on the use of transvaginal mesh in POP surgery comes from low to moderate quality, short-term studies of synthetic mesh that is no longer used in clinical practice,” said Cheryl Iglesia, MD, a Washington-based ob.gyn. who spoke to the advisory panel on behalf of the American College of Obstetricians and Gynecologists. “There’s a critical need for data from high-quality studies on the use of the newer, lightweight type 1 transvaginal meshes used in POP surgery.”
The FDA’s 522 orders requested that manufacturers conduct a randomized, controlled study or parallel cohort study comparing their device to native tissue repair. Requested effectiveness endpoints included anatomic success, subjective success, and retreatment for prolapse. For safety endpoints, the agency requested all device- and procedure-related adverse events, as well as the rate of individual adverse events, such as mesh erosion and de novo dyspareunia and urinary dysfunction. The FDA asked for all endpoints at 6-month intervals out to 24 months and at 36 months.
The panel advised that superiority should be the standard for the general population of women with POP – that mesh used in the anterior/apical vaginal compartment should be shown to be superior to native tissue repair at each time point. In specific patient populations for whom native tissue repair is not deemed feasible or appropriate, demonstrating equivalence is sufficient, they advised.
They called for “more diligent” presurgical assessments of sexual function and activity, as well as other symptoms that will be assessed later. And the panel agreed with the FDA that concomitant procedures (for example, hysterectomy and sling placement) and certain preexisting medical conditions and patient characteristics (such as obesity and diabetes) can affect outcomes and should be delineated and considered in the FDA’s evaluations and interpretation of study results.
Regarding surgeon characteristics, the panel’s biostatisticians and physicians (largely urogynecologists, but also one community ob.gyn.) advised the FDA to pay attention to surgeon training, experience, and volume, but they declined to offer any specific recommendations. Discussions often came back to the value of a registry that would capture both surgeon data and patient experience. And throughout the panel’s discussion, surgeons stepped away from the main questions at hand and emphasized the individualized nature of risk-benefit ratios and decision making.
Registries have been successfully used for cardiology and orthopedic implants and, within obstetrics and gynecology, for assisted reproductive technologies, Dr. Iglesia said in an interview after the meeting. “We have models … we just need to make it easy for physicians, using our EMRs. But I’m hopeful.”
The American Urogynecologic Society (AUGS) operates a quality improvement registry (AQUIRE) that is collecting information on surgical and nonsurgical treatment of POP and stress urinary incontinence – including surgical complications – from a diverse group of physicians, not just those at academic medical centers. AUGS is growing its registry this year to include device identifiers and patient-reported outcomes that are sent directly to the registry by the patient.
The panel generally agreed that postmarket follow-up of synthetic mesh for transvaginal anterior repair of POP should extend up to 5 years, Dr. Isaacson said, though “from the patients’ perspective, 10 years of experience [is meaningful].”
Geoffrey Cundiff, MD, who is AUGS president, told the committee that there are lessons to be gleaned from the CARE trial, which looked at outcomes up to 7 years after abdominal sacrocolpopexy (JAMA. 2013 May 15;309[19]:2016-24). “At 7 years, the complications [including rates of mesh erosion] had increased,” he said. “It’s a different procedure, but it’s a good example.”
Prior to its deliberations, the panel heard preliminary results of the ongoing SUPeR trial (Female Pelvic Med Reconstr Surg. 2016 Jul-Aug;22[4]:182-9), a randomized, controlled superiority trial of vaginal hysterectomy with suture apical suspension versus uterine conservation with vaginal mesh (Boston Scientific’s Uphold LITE) hysteropexy for uterovaginal prolapse. Researchers have found comparable rates of primary outcome success – no objective prolapse beyond the hymen, no retreatment, and no bulge symptoms – through 36 months and no differences in patient-reported outcomes thus far.
Hysteroplexy mesh exposure rates were approximately 8% at 36 months, and suture exposure and excessive granulation were 11%-20% in the hysterectomy group. None of these exposure cases has required reoperation. Both groups have shown improvements in sexual function and decreases in dyspareunia, said Charles W. Nager, MD, a San Diego ob.gyn. who is primary investigator of the trial.
The trial is sponsored by the Pelvic Floor Disorders Network of the National Institute of Child Health and Human Development, as was the CARE trial of abdominal sacrocolpopexy. It is following patients for 60 months and collecting data every 6 months, including data from validated functional and quality of life assessments. Patients were masked to their treatment assignment to eliminate patient reporting bias. At 36 months, approximately three-quarters of the patients in each group remained masked.
In addition to the ongoing 522 studies for anterior/apical prolapse, there is another 522 study underway of a mesh device designed for transvaginal repair of total prolapse (the Acell Matristem Pelvic Floor Repair Matrix). In addition, Coloplast is studying a mesh device designed for posterior/apical prolapse (Restorelle DirectFix) as part of its 522 study. Neither device is being marketed currently, however.
Patient-reported outcomes should be the priority consideration for determining whether the three synthetic mesh devices currently available for transvaginal repair of pelvic organ prolapse (POP) in the anterior vaginal compartment should remain on the market, according to the Food and Drug Administration Obstetrics and Gynecology Devices panel.
The panel was convened in February 2019 to advise the Food and Drug Administration on how it should evaluate the safety and effectiveness of the three currently marketed devices – each of which has ongoing postmarket surveillance studies – as well as any other similar devices that come up for premarket approval in the future.
The panel’s main messages: Subjective outcomes are what really matter – even more so than anatomic or objective outcomes – as does long-term follow-up.
“ “compared to native tissue repair,” said panel chair Keith Isaacson, MD, medical director of the Newton-Wellesley Hospital in Newton, Mass. “But we feel that, if we had to score [each category of outcome], about 75% should be subjective.”
The three devices currently marketed for transvaginal repair of POP (Boston Scientific’s Uphold LITE and Xenform, as well as Coloplast’s Restorelle DirectFix Anterior) are being scrutinized under a new regulatory paradigm and amid a charged backdrop of safety warnings and years of lawsuits regarding debilitating complications following surgeries that involved the implantation of synthetic vaginal mesh.
The two manufacturers of the currently available devices launched postmarket surveillance studies, called 522 studies, after the FDA issued postmarket surveillance study orders in 2012 to all manufacturers of surgical mesh for transvaginal repair of POP. (Most companies chose at the time to pull their products from the market.) This FDA action, along with a reclassification of the devices from class II to the high-risk class III, had been recommended at a 2011 meeting of the Obstetrics and Gynecology Devices panel.
In anticipation of a future reclassification, the 522 studies were designed at the time to support future premarket approval (PMA) applications, as advised by the FDA. Now, as a result of the 2016 reclassification of surgical mesh for transvaginal POP repair to class III – and the companies’ subsequent PMA applications – the FDA is reviewing the ongoing postmarket study results with a PMA lens to determine each device’s benefit/risk profile.
It’s a challenging assessment to make, FDA officials said.
The agency reported to the panel that a search of medical device reports from 2008 to 2018 identified 11,274 adverse events associated with mesh placed in the anterior vaginal compartment to treat POP. These included 10,391 reports of serious injury, 806 reports of device malfunctions, and 77 reports of death.
Findings from an FDA literature review covering the same period and also focusing on anterior and/or apical repair show that synthetic mesh may have some advantage over native tissue repair for objective effectiveness outcomes – but not necessarily subjective outcomes – over 1-3 years of follow-up. And the risks of using mesh are greater, particularly with respect to reoperation for recurrence and mesh complications, the latter of which continued beyond the first year of follow-up and through 5 years, the agency said.
Although the review may help the FDA frame its questions moving forward, it has limited utility beyond that, according to urogynecologic surgeons who testified on behalf of three professional societies. The review does not delineate differences between the newer materials used today and older mesh materials that were of heavier weight/higher mesh density and often placed using more invasive delivery systems. Nor does it offer any insight on the use of mesh for secondary repair.
“Much of the existing data on the use of transvaginal mesh in POP surgery comes from low to moderate quality, short-term studies of synthetic mesh that is no longer used in clinical practice,” said Cheryl Iglesia, MD, a Washington-based ob.gyn. who spoke to the advisory panel on behalf of the American College of Obstetricians and Gynecologists. “There’s a critical need for data from high-quality studies on the use of the newer, lightweight type 1 transvaginal meshes used in POP surgery.”
The FDA’s 522 orders requested that manufacturers conduct a randomized, controlled study or parallel cohort study comparing their device to native tissue repair. Requested effectiveness endpoints included anatomic success, subjective success, and retreatment for prolapse. For safety endpoints, the agency requested all device- and procedure-related adverse events, as well as the rate of individual adverse events, such as mesh erosion and de novo dyspareunia and urinary dysfunction. The FDA asked for all endpoints at 6-month intervals out to 24 months and at 36 months.
The panel advised that superiority should be the standard for the general population of women with POP – that mesh used in the anterior/apical vaginal compartment should be shown to be superior to native tissue repair at each time point. In specific patient populations for whom native tissue repair is not deemed feasible or appropriate, demonstrating equivalence is sufficient, they advised.
They called for “more diligent” presurgical assessments of sexual function and activity, as well as other symptoms that will be assessed later. And the panel agreed with the FDA that concomitant procedures (for example, hysterectomy and sling placement) and certain preexisting medical conditions and patient characteristics (such as obesity and diabetes) can affect outcomes and should be delineated and considered in the FDA’s evaluations and interpretation of study results.
Regarding surgeon characteristics, the panel’s biostatisticians and physicians (largely urogynecologists, but also one community ob.gyn.) advised the FDA to pay attention to surgeon training, experience, and volume, but they declined to offer any specific recommendations. Discussions often came back to the value of a registry that would capture both surgeon data and patient experience. And throughout the panel’s discussion, surgeons stepped away from the main questions at hand and emphasized the individualized nature of risk-benefit ratios and decision making.
Registries have been successfully used for cardiology and orthopedic implants and, within obstetrics and gynecology, for assisted reproductive technologies, Dr. Iglesia said in an interview after the meeting. “We have models … we just need to make it easy for physicians, using our EMRs. But I’m hopeful.”
The American Urogynecologic Society (AUGS) operates a quality improvement registry (AQUIRE) that is collecting information on surgical and nonsurgical treatment of POP and stress urinary incontinence – including surgical complications – from a diverse group of physicians, not just those at academic medical centers. AUGS is growing its registry this year to include device identifiers and patient-reported outcomes that are sent directly to the registry by the patient.
The panel generally agreed that postmarket follow-up of synthetic mesh for transvaginal anterior repair of POP should extend up to 5 years, Dr. Isaacson said, though “from the patients’ perspective, 10 years of experience [is meaningful].”
Geoffrey Cundiff, MD, who is AUGS president, told the committee that there are lessons to be gleaned from the CARE trial, which looked at outcomes up to 7 years after abdominal sacrocolpopexy (JAMA. 2013 May 15;309[19]:2016-24). “At 7 years, the complications [including rates of mesh erosion] had increased,” he said. “It’s a different procedure, but it’s a good example.”
Prior to its deliberations, the panel heard preliminary results of the ongoing SUPeR trial (Female Pelvic Med Reconstr Surg. 2016 Jul-Aug;22[4]:182-9), a randomized, controlled superiority trial of vaginal hysterectomy with suture apical suspension versus uterine conservation with vaginal mesh (Boston Scientific’s Uphold LITE) hysteropexy for uterovaginal prolapse. Researchers have found comparable rates of primary outcome success – no objective prolapse beyond the hymen, no retreatment, and no bulge symptoms – through 36 months and no differences in patient-reported outcomes thus far.
Hysteroplexy mesh exposure rates were approximately 8% at 36 months, and suture exposure and excessive granulation were 11%-20% in the hysterectomy group. None of these exposure cases has required reoperation. Both groups have shown improvements in sexual function and decreases in dyspareunia, said Charles W. Nager, MD, a San Diego ob.gyn. who is primary investigator of the trial.
The trial is sponsored by the Pelvic Floor Disorders Network of the National Institute of Child Health and Human Development, as was the CARE trial of abdominal sacrocolpopexy. It is following patients for 60 months and collecting data every 6 months, including data from validated functional and quality of life assessments. Patients were masked to their treatment assignment to eliminate patient reporting bias. At 36 months, approximately three-quarters of the patients in each group remained masked.
In addition to the ongoing 522 studies for anterior/apical prolapse, there is another 522 study underway of a mesh device designed for transvaginal repair of total prolapse (the Acell Matristem Pelvic Floor Repair Matrix). In addition, Coloplast is studying a mesh device designed for posterior/apical prolapse (Restorelle DirectFix) as part of its 522 study. Neither device is being marketed currently, however.
Patient-reported outcomes should be the priority consideration for determining whether the three synthetic mesh devices currently available for transvaginal repair of pelvic organ prolapse (POP) in the anterior vaginal compartment should remain on the market, according to the Food and Drug Administration Obstetrics and Gynecology Devices panel.
The panel was convened in February 2019 to advise the Food and Drug Administration on how it should evaluate the safety and effectiveness of the three currently marketed devices – each of which has ongoing postmarket surveillance studies – as well as any other similar devices that come up for premarket approval in the future.
The panel’s main messages: Subjective outcomes are what really matter – even more so than anatomic or objective outcomes – as does long-term follow-up.
“ “compared to native tissue repair,” said panel chair Keith Isaacson, MD, medical director of the Newton-Wellesley Hospital in Newton, Mass. “But we feel that, if we had to score [each category of outcome], about 75% should be subjective.”
The three devices currently marketed for transvaginal repair of POP (Boston Scientific’s Uphold LITE and Xenform, as well as Coloplast’s Restorelle DirectFix Anterior) are being scrutinized under a new regulatory paradigm and amid a charged backdrop of safety warnings and years of lawsuits regarding debilitating complications following surgeries that involved the implantation of synthetic vaginal mesh.
The two manufacturers of the currently available devices launched postmarket surveillance studies, called 522 studies, after the FDA issued postmarket surveillance study orders in 2012 to all manufacturers of surgical mesh for transvaginal repair of POP. (Most companies chose at the time to pull their products from the market.) This FDA action, along with a reclassification of the devices from class II to the high-risk class III, had been recommended at a 2011 meeting of the Obstetrics and Gynecology Devices panel.
In anticipation of a future reclassification, the 522 studies were designed at the time to support future premarket approval (PMA) applications, as advised by the FDA. Now, as a result of the 2016 reclassification of surgical mesh for transvaginal POP repair to class III – and the companies’ subsequent PMA applications – the FDA is reviewing the ongoing postmarket study results with a PMA lens to determine each device’s benefit/risk profile.
It’s a challenging assessment to make, FDA officials said.
The agency reported to the panel that a search of medical device reports from 2008 to 2018 identified 11,274 adverse events associated with mesh placed in the anterior vaginal compartment to treat POP. These included 10,391 reports of serious injury, 806 reports of device malfunctions, and 77 reports of death.
Findings from an FDA literature review covering the same period and also focusing on anterior and/or apical repair show that synthetic mesh may have some advantage over native tissue repair for objective effectiveness outcomes – but not necessarily subjective outcomes – over 1-3 years of follow-up. And the risks of using mesh are greater, particularly with respect to reoperation for recurrence and mesh complications, the latter of which continued beyond the first year of follow-up and through 5 years, the agency said.
Although the review may help the FDA frame its questions moving forward, it has limited utility beyond that, according to urogynecologic surgeons who testified on behalf of three professional societies. The review does not delineate differences between the newer materials used today and older mesh materials that were of heavier weight/higher mesh density and often placed using more invasive delivery systems. Nor does it offer any insight on the use of mesh for secondary repair.
“Much of the existing data on the use of transvaginal mesh in POP surgery comes from low to moderate quality, short-term studies of synthetic mesh that is no longer used in clinical practice,” said Cheryl Iglesia, MD, a Washington-based ob.gyn. who spoke to the advisory panel on behalf of the American College of Obstetricians and Gynecologists. “There’s a critical need for data from high-quality studies on the use of the newer, lightweight type 1 transvaginal meshes used in POP surgery.”
The FDA’s 522 orders requested that manufacturers conduct a randomized, controlled study or parallel cohort study comparing their device to native tissue repair. Requested effectiveness endpoints included anatomic success, subjective success, and retreatment for prolapse. For safety endpoints, the agency requested all device- and procedure-related adverse events, as well as the rate of individual adverse events, such as mesh erosion and de novo dyspareunia and urinary dysfunction. The FDA asked for all endpoints at 6-month intervals out to 24 months and at 36 months.
The panel advised that superiority should be the standard for the general population of women with POP – that mesh used in the anterior/apical vaginal compartment should be shown to be superior to native tissue repair at each time point. In specific patient populations for whom native tissue repair is not deemed feasible or appropriate, demonstrating equivalence is sufficient, they advised.
They called for “more diligent” presurgical assessments of sexual function and activity, as well as other symptoms that will be assessed later. And the panel agreed with the FDA that concomitant procedures (for example, hysterectomy and sling placement) and certain preexisting medical conditions and patient characteristics (such as obesity and diabetes) can affect outcomes and should be delineated and considered in the FDA’s evaluations and interpretation of study results.
Regarding surgeon characteristics, the panel’s biostatisticians and physicians (largely urogynecologists, but also one community ob.gyn.) advised the FDA to pay attention to surgeon training, experience, and volume, but they declined to offer any specific recommendations. Discussions often came back to the value of a registry that would capture both surgeon data and patient experience. And throughout the panel’s discussion, surgeons stepped away from the main questions at hand and emphasized the individualized nature of risk-benefit ratios and decision making.
Registries have been successfully used for cardiology and orthopedic implants and, within obstetrics and gynecology, for assisted reproductive technologies, Dr. Iglesia said in an interview after the meeting. “We have models … we just need to make it easy for physicians, using our EMRs. But I’m hopeful.”
The American Urogynecologic Society (AUGS) operates a quality improvement registry (AQUIRE) that is collecting information on surgical and nonsurgical treatment of POP and stress urinary incontinence – including surgical complications – from a diverse group of physicians, not just those at academic medical centers. AUGS is growing its registry this year to include device identifiers and patient-reported outcomes that are sent directly to the registry by the patient.
The panel generally agreed that postmarket follow-up of synthetic mesh for transvaginal anterior repair of POP should extend up to 5 years, Dr. Isaacson said, though “from the patients’ perspective, 10 years of experience [is meaningful].”
Geoffrey Cundiff, MD, who is AUGS president, told the committee that there are lessons to be gleaned from the CARE trial, which looked at outcomes up to 7 years after abdominal sacrocolpopexy (JAMA. 2013 May 15;309[19]:2016-24). “At 7 years, the complications [including rates of mesh erosion] had increased,” he said. “It’s a different procedure, but it’s a good example.”
Prior to its deliberations, the panel heard preliminary results of the ongoing SUPeR trial (Female Pelvic Med Reconstr Surg. 2016 Jul-Aug;22[4]:182-9), a randomized, controlled superiority trial of vaginal hysterectomy with suture apical suspension versus uterine conservation with vaginal mesh (Boston Scientific’s Uphold LITE) hysteropexy for uterovaginal prolapse. Researchers have found comparable rates of primary outcome success – no objective prolapse beyond the hymen, no retreatment, and no bulge symptoms – through 36 months and no differences in patient-reported outcomes thus far.
Hysteroplexy mesh exposure rates were approximately 8% at 36 months, and suture exposure and excessive granulation were 11%-20% in the hysterectomy group. None of these exposure cases has required reoperation. Both groups have shown improvements in sexual function and decreases in dyspareunia, said Charles W. Nager, MD, a San Diego ob.gyn. who is primary investigator of the trial.
The trial is sponsored by the Pelvic Floor Disorders Network of the National Institute of Child Health and Human Development, as was the CARE trial of abdominal sacrocolpopexy. It is following patients for 60 months and collecting data every 6 months, including data from validated functional and quality of life assessments. Patients were masked to their treatment assignment to eliminate patient reporting bias. At 36 months, approximately three-quarters of the patients in each group remained masked.
In addition to the ongoing 522 studies for anterior/apical prolapse, there is another 522 study underway of a mesh device designed for transvaginal repair of total prolapse (the Acell Matristem Pelvic Floor Repair Matrix). In addition, Coloplast is studying a mesh device designed for posterior/apical prolapse (Restorelle DirectFix) as part of its 522 study. Neither device is being marketed currently, however.
Riboflavin helps visualize urine flow during cystoscopy
By increasing urine color, 400 mg of oral riboflavin the night before gynecologic surgery makes it easier to see and confirm urine flow during intraoperative cystoscopy, according to results of a randomized, blinded, placebo-controlled trial.
The traditional go-to for that purpose, intravenous indigo carmine, has been in short supply, if possible to get at all, so surgeons have been looking for other options. Alternatives include intravenous methylene blue, intravenous fluorescein, and oral phenazopyridine, but each have their own problems, including cost, contraindications, and anaphylaxis.
So the study team turned to riboflavin – vitamin B2 – which, in excess, turns the urine bright, sometimes almost neon yellow. It’s “safe, readily available without prescription, and inexpensive ... and should be considered for routine use,” wrote investigators led by Michael L. Stitely, MD, an ob.gyn. at the University of Otago in Dunedin, New Zealand.
The team randomized 33 women to four 100-mg capsules of riboflavin the night before surgery and 33 to four 1,000-IU capsules of vitamin D3, which served as the placebo. Participants, clinicians, researchers, and study staff all were blinded to group allocation, the investigators noted in Obstetrics & Gynecology.
Surgeons rated urine color a median of 2 (slight yellow) in the riboflavin group, compared with 1 (clear) in the placebo arm, on a 3-point scale (P less than .001). About 13 women on riboflavin got a rating of 3 – strong yellow – versus 1 woman in the placebo arm.
The operating surgeons also said it was easier to visualize urine flow in the riboflavin group, giving a median of 5, compared with 4 in the placebo group, on a 5-point scale (P less than .013). They gave a score of 5 to 19 women in the riboflavin group but only to 8 placebo women, meaning that they “strongly agreed” that it was easy to see urine flow; a score of 4 meant that they simply agreed with the statement.
Overall, surgeons confirmed bilateral urine flow in 30 women (91%) in the riboflavin group, compared with 28 women (85%) in the placebo group (P = .71). When a blinded investigator checked the videos, their assessments of the same parameters correlated with those of the surgeons.
No significant differences were found between the groups in age, height, weight, body mass index, or ethnicity. The most common procedure was a midurethral sling (10 in the riboflavin group; 4 in the placebo arm), followed by cystoscopy with botox (4 in the riboflavin group; 7 in the placebo group). None of the women required intervention for urinary tract injury.
Among the limitations cited was the use of subjective and nonvalidated measures of urine color.
The work was funded by the Healthcare Otago Charitable Trust and the Australasian Gynaecological Endoscopy and Surgery Society. The authors reported no conflicts of interest.
SOURCE: Stitely ML et al. Obstet Gynecol. 2019 Jan 8. doi: 10.1097/AOG.0000000000003063.
By increasing urine color, 400 mg of oral riboflavin the night before gynecologic surgery makes it easier to see and confirm urine flow during intraoperative cystoscopy, according to results of a randomized, blinded, placebo-controlled trial.
The traditional go-to for that purpose, intravenous indigo carmine, has been in short supply, if possible to get at all, so surgeons have been looking for other options. Alternatives include intravenous methylene blue, intravenous fluorescein, and oral phenazopyridine, but each have their own problems, including cost, contraindications, and anaphylaxis.
So the study team turned to riboflavin – vitamin B2 – which, in excess, turns the urine bright, sometimes almost neon yellow. It’s “safe, readily available without prescription, and inexpensive ... and should be considered for routine use,” wrote investigators led by Michael L. Stitely, MD, an ob.gyn. at the University of Otago in Dunedin, New Zealand.
The team randomized 33 women to four 100-mg capsules of riboflavin the night before surgery and 33 to four 1,000-IU capsules of vitamin D3, which served as the placebo. Participants, clinicians, researchers, and study staff all were blinded to group allocation, the investigators noted in Obstetrics & Gynecology.
Surgeons rated urine color a median of 2 (slight yellow) in the riboflavin group, compared with 1 (clear) in the placebo arm, on a 3-point scale (P less than .001). About 13 women on riboflavin got a rating of 3 – strong yellow – versus 1 woman in the placebo arm.
The operating surgeons also said it was easier to visualize urine flow in the riboflavin group, giving a median of 5, compared with 4 in the placebo group, on a 5-point scale (P less than .013). They gave a score of 5 to 19 women in the riboflavin group but only to 8 placebo women, meaning that they “strongly agreed” that it was easy to see urine flow; a score of 4 meant that they simply agreed with the statement.
Overall, surgeons confirmed bilateral urine flow in 30 women (91%) in the riboflavin group, compared with 28 women (85%) in the placebo group (P = .71). When a blinded investigator checked the videos, their assessments of the same parameters correlated with those of the surgeons.
No significant differences were found between the groups in age, height, weight, body mass index, or ethnicity. The most common procedure was a midurethral sling (10 in the riboflavin group; 4 in the placebo arm), followed by cystoscopy with botox (4 in the riboflavin group; 7 in the placebo group). None of the women required intervention for urinary tract injury.
Among the limitations cited was the use of subjective and nonvalidated measures of urine color.
The work was funded by the Healthcare Otago Charitable Trust and the Australasian Gynaecological Endoscopy and Surgery Society. The authors reported no conflicts of interest.
SOURCE: Stitely ML et al. Obstet Gynecol. 2019 Jan 8. doi: 10.1097/AOG.0000000000003063.
By increasing urine color, 400 mg of oral riboflavin the night before gynecologic surgery makes it easier to see and confirm urine flow during intraoperative cystoscopy, according to results of a randomized, blinded, placebo-controlled trial.
The traditional go-to for that purpose, intravenous indigo carmine, has been in short supply, if possible to get at all, so surgeons have been looking for other options. Alternatives include intravenous methylene blue, intravenous fluorescein, and oral phenazopyridine, but each have their own problems, including cost, contraindications, and anaphylaxis.
So the study team turned to riboflavin – vitamin B2 – which, in excess, turns the urine bright, sometimes almost neon yellow. It’s “safe, readily available without prescription, and inexpensive ... and should be considered for routine use,” wrote investigators led by Michael L. Stitely, MD, an ob.gyn. at the University of Otago in Dunedin, New Zealand.
The team randomized 33 women to four 100-mg capsules of riboflavin the night before surgery and 33 to four 1,000-IU capsules of vitamin D3, which served as the placebo. Participants, clinicians, researchers, and study staff all were blinded to group allocation, the investigators noted in Obstetrics & Gynecology.
Surgeons rated urine color a median of 2 (slight yellow) in the riboflavin group, compared with 1 (clear) in the placebo arm, on a 3-point scale (P less than .001). About 13 women on riboflavin got a rating of 3 – strong yellow – versus 1 woman in the placebo arm.
The operating surgeons also said it was easier to visualize urine flow in the riboflavin group, giving a median of 5, compared with 4 in the placebo group, on a 5-point scale (P less than .013). They gave a score of 5 to 19 women in the riboflavin group but only to 8 placebo women, meaning that they “strongly agreed” that it was easy to see urine flow; a score of 4 meant that they simply agreed with the statement.
Overall, surgeons confirmed bilateral urine flow in 30 women (91%) in the riboflavin group, compared with 28 women (85%) in the placebo group (P = .71). When a blinded investigator checked the videos, their assessments of the same parameters correlated with those of the surgeons.
No significant differences were found between the groups in age, height, weight, body mass index, or ethnicity. The most common procedure was a midurethral sling (10 in the riboflavin group; 4 in the placebo arm), followed by cystoscopy with botox (4 in the riboflavin group; 7 in the placebo group). None of the women required intervention for urinary tract injury.
Among the limitations cited was the use of subjective and nonvalidated measures of urine color.
The work was funded by the Healthcare Otago Charitable Trust and the Australasian Gynaecological Endoscopy and Surgery Society. The authors reported no conflicts of interest.
SOURCE: Stitely ML et al. Obstet Gynecol. 2019 Jan 8. doi: 10.1097/AOG.0000000000003063.
FROM OBSTETRICS & GYNECOLOGY
Key clinical point: Oral riboflavin the night before gynecologic surgery is a sound alternative to indigo carmine for cystoscopy visualization.
Major finding: Surgeons rated urine color a median of 2 (slight yellow) in the riboflavin group, compared with 1 (clear) in the placebo arm on a 3-point scale (P less than .001). About 13 women on riboflavin got a rating of 3 – strong yellow – versus 1 woman in the placebo arm.
Study details: A randomized trial with 66 women.
Disclosures: The work was funded by the Healthcare Otago Charitable Trust and the Australasian Gynaecological Endoscopy and Surgery Society. The authors reported no conflicts of interest.
Source: Stitely ML et al. Obstet Gynecol. 2019 Jan 8. doi: 10.1097/AOG.0000000000003063.
Preoperative acetaminophen does not improve prolapse surgery pain
Preoperative intravenous acetaminophen does not appear to reduce postoperative pain in women undergoing surgery for pelvic organ prolapse, new research suggests.
“Owing to its lack of clinical benefit, routine use of IV acetaminophen as the sole preemptive analgesia agent is not supported by this study,” reported Lindsay C. Turner, MD, of the department of obstetrics and gynecology at the Allegheny Health Network in Pittsburgh, and her coauthors.
In a double-blind placebo-controlled trial, published in Obstetrics & Gynecology, Dr. Turner and her coauthors randomized 202 women undergoing laparoscopic or vaginal surgery to either 1,000 mg intravenous acetaminophen or saline.
Among the 162 patients for whom pain score data were available at baseline and 24 hours after surgery, there were no significant differences in the mean change in pain scores from baseline to 24 hours between the acetaminophen group and the placebo group, or at any other time point in the 24 hours, regardless of surgical route.
, which was similar between the intervention and placebo groups, irrespective of surgical route.
The women in the study also were asked to complete pain diaries for the 7 days after their operation. This revealed no significant difference between the acetaminophen and placebo groups in narcotic pain relief use during that week. Patients used a median of 30 of the narcotic tablets prescribed at discharge, which represented less than one-quarter of the total tablets prescribed.
“Although preoperative IV acetaminophen is included in many extended recovery pathways owing to its improvement in pain scores and reduction in narcotic use after many other types of procedures, the use of IV acetaminophen alone before surgery for [pelvic organ prolapse] is not supported,” wrote Dr. Turner and her coauthors.
The rates of side effects, such as nausea, drowsiness, itching, or dizziness also were similar between the two groups. However, Dr. Turner and her coauthors noted a significantly higher rate of urinary retention among women who underwent surgery by the vaginal route and received intravenous acetaminophen, compared with those who received placebo (59.2% vs. 33.3%; P = .01).
“The increased rates of urinary retention with IV acetaminophen in women undergoing vaginal surgery are surprising, because more women in the placebo group underwent posterior repair, which historically has been thought to increase risks of postoperative urinary retention,” the authors wrote. They suggested that the medium in which the IV acetaminophen was suspended might have had a diuretic effect but said that further study was needed to explore the observation.
Dr. Turner and her coauthors cited as a limitation the absence of primary outcome data for 40 of the patients. They said the inconsistency found in the patients’ completion of postoperative and pain diaries was a limitation.
The study was supported by the American Urogynecologic Society Pelvic Floor Disorders Research Foundation. No conflicts of interest were declared.
SOURCE: Turner LC et al. Obstet Gynecol. 2019;133:492-502.
Preoperative intravenous acetaminophen does not appear to reduce postoperative pain in women undergoing surgery for pelvic organ prolapse, new research suggests.
“Owing to its lack of clinical benefit, routine use of IV acetaminophen as the sole preemptive analgesia agent is not supported by this study,” reported Lindsay C. Turner, MD, of the department of obstetrics and gynecology at the Allegheny Health Network in Pittsburgh, and her coauthors.
In a double-blind placebo-controlled trial, published in Obstetrics & Gynecology, Dr. Turner and her coauthors randomized 202 women undergoing laparoscopic or vaginal surgery to either 1,000 mg intravenous acetaminophen or saline.
Among the 162 patients for whom pain score data were available at baseline and 24 hours after surgery, there were no significant differences in the mean change in pain scores from baseline to 24 hours between the acetaminophen group and the placebo group, or at any other time point in the 24 hours, regardless of surgical route.
, which was similar between the intervention and placebo groups, irrespective of surgical route.
The women in the study also were asked to complete pain diaries for the 7 days after their operation. This revealed no significant difference between the acetaminophen and placebo groups in narcotic pain relief use during that week. Patients used a median of 30 of the narcotic tablets prescribed at discharge, which represented less than one-quarter of the total tablets prescribed.
“Although preoperative IV acetaminophen is included in many extended recovery pathways owing to its improvement in pain scores and reduction in narcotic use after many other types of procedures, the use of IV acetaminophen alone before surgery for [pelvic organ prolapse] is not supported,” wrote Dr. Turner and her coauthors.
The rates of side effects, such as nausea, drowsiness, itching, or dizziness also were similar between the two groups. However, Dr. Turner and her coauthors noted a significantly higher rate of urinary retention among women who underwent surgery by the vaginal route and received intravenous acetaminophen, compared with those who received placebo (59.2% vs. 33.3%; P = .01).
“The increased rates of urinary retention with IV acetaminophen in women undergoing vaginal surgery are surprising, because more women in the placebo group underwent posterior repair, which historically has been thought to increase risks of postoperative urinary retention,” the authors wrote. They suggested that the medium in which the IV acetaminophen was suspended might have had a diuretic effect but said that further study was needed to explore the observation.
Dr. Turner and her coauthors cited as a limitation the absence of primary outcome data for 40 of the patients. They said the inconsistency found in the patients’ completion of postoperative and pain diaries was a limitation.
The study was supported by the American Urogynecologic Society Pelvic Floor Disorders Research Foundation. No conflicts of interest were declared.
SOURCE: Turner LC et al. Obstet Gynecol. 2019;133:492-502.
Preoperative intravenous acetaminophen does not appear to reduce postoperative pain in women undergoing surgery for pelvic organ prolapse, new research suggests.
“Owing to its lack of clinical benefit, routine use of IV acetaminophen as the sole preemptive analgesia agent is not supported by this study,” reported Lindsay C. Turner, MD, of the department of obstetrics and gynecology at the Allegheny Health Network in Pittsburgh, and her coauthors.
In a double-blind placebo-controlled trial, published in Obstetrics & Gynecology, Dr. Turner and her coauthors randomized 202 women undergoing laparoscopic or vaginal surgery to either 1,000 mg intravenous acetaminophen or saline.
Among the 162 patients for whom pain score data were available at baseline and 24 hours after surgery, there were no significant differences in the mean change in pain scores from baseline to 24 hours between the acetaminophen group and the placebo group, or at any other time point in the 24 hours, regardless of surgical route.
, which was similar between the intervention and placebo groups, irrespective of surgical route.
The women in the study also were asked to complete pain diaries for the 7 days after their operation. This revealed no significant difference between the acetaminophen and placebo groups in narcotic pain relief use during that week. Patients used a median of 30 of the narcotic tablets prescribed at discharge, which represented less than one-quarter of the total tablets prescribed.
“Although preoperative IV acetaminophen is included in many extended recovery pathways owing to its improvement in pain scores and reduction in narcotic use after many other types of procedures, the use of IV acetaminophen alone before surgery for [pelvic organ prolapse] is not supported,” wrote Dr. Turner and her coauthors.
The rates of side effects, such as nausea, drowsiness, itching, or dizziness also were similar between the two groups. However, Dr. Turner and her coauthors noted a significantly higher rate of urinary retention among women who underwent surgery by the vaginal route and received intravenous acetaminophen, compared with those who received placebo (59.2% vs. 33.3%; P = .01).
“The increased rates of urinary retention with IV acetaminophen in women undergoing vaginal surgery are surprising, because more women in the placebo group underwent posterior repair, which historically has been thought to increase risks of postoperative urinary retention,” the authors wrote. They suggested that the medium in which the IV acetaminophen was suspended might have had a diuretic effect but said that further study was needed to explore the observation.
Dr. Turner and her coauthors cited as a limitation the absence of primary outcome data for 40 of the patients. They said the inconsistency found in the patients’ completion of postoperative and pain diaries was a limitation.
The study was supported by the American Urogynecologic Society Pelvic Floor Disorders Research Foundation. No conflicts of interest were declared.
SOURCE: Turner LC et al. Obstet Gynecol. 2019;133:492-502.
FROM OBSTETRICS & GYNECOLOGY
Key clinical point: “Routine use of IV acetaminophen as the sole preemptive analgesia agent is not supported by this study.”
Major finding: Pain scores and narcotic use were similar in women given preoperative IV acetaminophen and those given placebo.
Study details: Prospective randomized, controlled trial in 202 women undergoing prolapse surgery.
Disclosures: The study was supported by the American Urogynecologic Society Pelvic Floor Disorders Research Foundation. No conflicts of interest were declared.
Source: Turner LC et al. Obstet Gynecol. 2019;133:492-502.
Surgeon: Sacral colpopexy can be smart strategy in POP repairs
LAS VEGAS – While research suggests that vaginal mesh grafts are inappropriate for many prolapse repairs, an obstetrician-gynecologist told colleagues that they’re still a valid tool in the repair procedure known as sacral colpopexy, in which mesh is attached via an abdominal route.
Beri M. Ridgeway, MD, of Cleveland Clinic, spoke about the role of mesh grafts and prolapse repairs at the Pelvic Anatomy and Gynecologic Surgery Symposium.
As Dr. Ridgeway noted, vaginal mesh grafts are controversial because of concerns about their safety. Although many women had favorable outcomes, an unacceptable proportion have experienced complications.
In 2011, the Food and Drug Administration warned that urogynecologic surgical mesh had been linked to 2,874 reports of injuries, deaths, and malfunctions, mostly in pelvic organ prolapse (POP) repairs, over 3 years. The other injuries were in stress urinary incontinence repairs. The report focuses on transvaginal mesh for prolapse and not sacral colpopexy or synthetic midurethral slings, which are considered to have a more favorable risk profile.
The FDA declared that “serious adverse events are NOT rare ... and transvaginally placed mesh in POP repair does NOT conclusively improve clinical outcomes over traditional non-mesh repair.” Subsequently, most companies stopped marketing mesh for transvaginal repair of POP.
Since 2011, research has offered new perspective on the use of mesh in specific POP situations.
“We know that mesh does have some slight improvement in medium-term outcome for subjective and objective symptoms,” Dr. Ridgeway said at the meeting, which was jointly provided by Global Academy for Medical Education and the University of Cincinnati. “This all comes at a price. There’s more blood loss, and you can actually have prolapse in other compartments and de novo SUI.”
She pointed out that these outcomes were noted in a 2013 Cochrane Review. It found improvements in subjective and objective results after treatment with polypropylene mesh vs. native tissue for anterior compartment POP repairs. But the review found multiple disadvantages for mesh vs. native tissue in operating time, blood loss, and reoperations (Cochrane Database Syst Rev. 2013 Apr 30;[4]:CD004014).
In 2016, an updated Cochrane Review declared that “current evidence does not support the use of mesh repair compared with native tissue repair for anterior compartment prolapse owing to increased morbidity.” The review also cautioned that while new light-weight transvaginal meshes are available, they haven’t been fully studied. “Clinicians and women should be cautious when utilizing these products, as their safety and efficacy have not been established,” according to the review (Cochrane Database of Syst Rev. 2016[11];CD004014).
In a follow-up interview, Dr. Ridgeway said “the data are scarce, so it is hard to have an opinion on this.”
She focused much of her presentation on sacral colpopexy. .
“Compared to native tissue prolapse repair using a vaginal approach, sacral colpopexy does have an increased risk profile but likely is associated with better durability,” she said in the interview. “The long-term outcomes following sacral colpopexy are favorable and the risk profile is acceptably low.”
She prefers the approach for recurrent prolapse and post-hysterectomy prolapse, especially in patients with a shorter vagina. She also offers this procedure for younger patients with significant prolapse and those women who are very active or perform repetitive heavy lifting.
In the interview, she offered these tips about the procedure:
- “Identify pertinent anatomy and set yourself up for success. Restore anatomy, retract the colon if necessary, use angled laparoscopes to optimize visualization, and don’t place the vagina on significant tension.”
- “In cases with unusual anatomy, one must recheck anatomic landmarks because it is critical to avoid the middle sacral artery and left common iliac vein, which is often located close to the midline.”
- “The vagina should be well supported but not on tension. One must communicate with assistants to elevate the vagina but not push it too much. I often demonstrate to the assistant how I like it to be.”
- “In regard to closing the peritoneum over the mesh, I like to make sure this dissection is sufficient at the beginning of the case so this part is not a struggle.”
Dr. Ridgeway discloses consulting for Coloplast and serving as an independent contractor (Legal) for Ethicon.
Global Academy and this news organization are owned by the same company.
LAS VEGAS – While research suggests that vaginal mesh grafts are inappropriate for many prolapse repairs, an obstetrician-gynecologist told colleagues that they’re still a valid tool in the repair procedure known as sacral colpopexy, in which mesh is attached via an abdominal route.
Beri M. Ridgeway, MD, of Cleveland Clinic, spoke about the role of mesh grafts and prolapse repairs at the Pelvic Anatomy and Gynecologic Surgery Symposium.
As Dr. Ridgeway noted, vaginal mesh grafts are controversial because of concerns about their safety. Although many women had favorable outcomes, an unacceptable proportion have experienced complications.
In 2011, the Food and Drug Administration warned that urogynecologic surgical mesh had been linked to 2,874 reports of injuries, deaths, and malfunctions, mostly in pelvic organ prolapse (POP) repairs, over 3 years. The other injuries were in stress urinary incontinence repairs. The report focuses on transvaginal mesh for prolapse and not sacral colpopexy or synthetic midurethral slings, which are considered to have a more favorable risk profile.
The FDA declared that “serious adverse events are NOT rare ... and transvaginally placed mesh in POP repair does NOT conclusively improve clinical outcomes over traditional non-mesh repair.” Subsequently, most companies stopped marketing mesh for transvaginal repair of POP.
Since 2011, research has offered new perspective on the use of mesh in specific POP situations.
“We know that mesh does have some slight improvement in medium-term outcome for subjective and objective symptoms,” Dr. Ridgeway said at the meeting, which was jointly provided by Global Academy for Medical Education and the University of Cincinnati. “This all comes at a price. There’s more blood loss, and you can actually have prolapse in other compartments and de novo SUI.”
She pointed out that these outcomes were noted in a 2013 Cochrane Review. It found improvements in subjective and objective results after treatment with polypropylene mesh vs. native tissue for anterior compartment POP repairs. But the review found multiple disadvantages for mesh vs. native tissue in operating time, blood loss, and reoperations (Cochrane Database Syst Rev. 2013 Apr 30;[4]:CD004014).
In 2016, an updated Cochrane Review declared that “current evidence does not support the use of mesh repair compared with native tissue repair for anterior compartment prolapse owing to increased morbidity.” The review also cautioned that while new light-weight transvaginal meshes are available, they haven’t been fully studied. “Clinicians and women should be cautious when utilizing these products, as their safety and efficacy have not been established,” according to the review (Cochrane Database of Syst Rev. 2016[11];CD004014).
In a follow-up interview, Dr. Ridgeway said “the data are scarce, so it is hard to have an opinion on this.”
She focused much of her presentation on sacral colpopexy. .
“Compared to native tissue prolapse repair using a vaginal approach, sacral colpopexy does have an increased risk profile but likely is associated with better durability,” she said in the interview. “The long-term outcomes following sacral colpopexy are favorable and the risk profile is acceptably low.”
She prefers the approach for recurrent prolapse and post-hysterectomy prolapse, especially in patients with a shorter vagina. She also offers this procedure for younger patients with significant prolapse and those women who are very active or perform repetitive heavy lifting.
In the interview, she offered these tips about the procedure:
- “Identify pertinent anatomy and set yourself up for success. Restore anatomy, retract the colon if necessary, use angled laparoscopes to optimize visualization, and don’t place the vagina on significant tension.”
- “In cases with unusual anatomy, one must recheck anatomic landmarks because it is critical to avoid the middle sacral artery and left common iliac vein, which is often located close to the midline.”
- “The vagina should be well supported but not on tension. One must communicate with assistants to elevate the vagina but not push it too much. I often demonstrate to the assistant how I like it to be.”
- “In regard to closing the peritoneum over the mesh, I like to make sure this dissection is sufficient at the beginning of the case so this part is not a struggle.”
Dr. Ridgeway discloses consulting for Coloplast and serving as an independent contractor (Legal) for Ethicon.
Global Academy and this news organization are owned by the same company.
LAS VEGAS – While research suggests that vaginal mesh grafts are inappropriate for many prolapse repairs, an obstetrician-gynecologist told colleagues that they’re still a valid tool in the repair procedure known as sacral colpopexy, in which mesh is attached via an abdominal route.
Beri M. Ridgeway, MD, of Cleveland Clinic, spoke about the role of mesh grafts and prolapse repairs at the Pelvic Anatomy and Gynecologic Surgery Symposium.
As Dr. Ridgeway noted, vaginal mesh grafts are controversial because of concerns about their safety. Although many women had favorable outcomes, an unacceptable proportion have experienced complications.
In 2011, the Food and Drug Administration warned that urogynecologic surgical mesh had been linked to 2,874 reports of injuries, deaths, and malfunctions, mostly in pelvic organ prolapse (POP) repairs, over 3 years. The other injuries were in stress urinary incontinence repairs. The report focuses on transvaginal mesh for prolapse and not sacral colpopexy or synthetic midurethral slings, which are considered to have a more favorable risk profile.
The FDA declared that “serious adverse events are NOT rare ... and transvaginally placed mesh in POP repair does NOT conclusively improve clinical outcomes over traditional non-mesh repair.” Subsequently, most companies stopped marketing mesh for transvaginal repair of POP.
Since 2011, research has offered new perspective on the use of mesh in specific POP situations.
“We know that mesh does have some slight improvement in medium-term outcome for subjective and objective symptoms,” Dr. Ridgeway said at the meeting, which was jointly provided by Global Academy for Medical Education and the University of Cincinnati. “This all comes at a price. There’s more blood loss, and you can actually have prolapse in other compartments and de novo SUI.”
She pointed out that these outcomes were noted in a 2013 Cochrane Review. It found improvements in subjective and objective results after treatment with polypropylene mesh vs. native tissue for anterior compartment POP repairs. But the review found multiple disadvantages for mesh vs. native tissue in operating time, blood loss, and reoperations (Cochrane Database Syst Rev. 2013 Apr 30;[4]:CD004014).
In 2016, an updated Cochrane Review declared that “current evidence does not support the use of mesh repair compared with native tissue repair for anterior compartment prolapse owing to increased morbidity.” The review also cautioned that while new light-weight transvaginal meshes are available, they haven’t been fully studied. “Clinicians and women should be cautious when utilizing these products, as their safety and efficacy have not been established,” according to the review (Cochrane Database of Syst Rev. 2016[11];CD004014).
In a follow-up interview, Dr. Ridgeway said “the data are scarce, so it is hard to have an opinion on this.”
She focused much of her presentation on sacral colpopexy. .
“Compared to native tissue prolapse repair using a vaginal approach, sacral colpopexy does have an increased risk profile but likely is associated with better durability,” she said in the interview. “The long-term outcomes following sacral colpopexy are favorable and the risk profile is acceptably low.”
She prefers the approach for recurrent prolapse and post-hysterectomy prolapse, especially in patients with a shorter vagina. She also offers this procedure for younger patients with significant prolapse and those women who are very active or perform repetitive heavy lifting.
In the interview, she offered these tips about the procedure:
- “Identify pertinent anatomy and set yourself up for success. Restore anatomy, retract the colon if necessary, use angled laparoscopes to optimize visualization, and don’t place the vagina on significant tension.”
- “In cases with unusual anatomy, one must recheck anatomic landmarks because it is critical to avoid the middle sacral artery and left common iliac vein, which is often located close to the midline.”
- “The vagina should be well supported but not on tension. One must communicate with assistants to elevate the vagina but not push it too much. I often demonstrate to the assistant how I like it to be.”
- “In regard to closing the peritoneum over the mesh, I like to make sure this dissection is sufficient at the beginning of the case so this part is not a struggle.”
Dr. Ridgeway discloses consulting for Coloplast and serving as an independent contractor (Legal) for Ethicon.
Global Academy and this news organization are owned by the same company.
EXPERT ANALYSIS FROM PAGS