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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
Furosemide speeds ureteral patency confirmation, but is time savings worth the risk?
TUCSON, ARIZ. – according to results from a new randomized, controlled trial.
“It does make a difference, but is that really a [meaningful] difference? Every medication has adverse effects, so is it worth that extra time [savings] to take on that potential for side effects? It highlights the importance of statistical significance versus clinical significance, and I think [the clinical significance] can just be answered by each individual physician,” Simon Patton, MD, said in an interview.
Dr. Patton is a urogynecologist at Ascension Via Christi Medical Group in Wichita, Kan. He presented the study, which was conducted during his time as a fellow at the University of South Florida, Tampa, at the annual scientific meeting of the Society of Gynecologic Surgeons. Dr. Patton isn’t sure just how often physicians use furosemide during routine cystoscopy. “It would be great to do a survey to find out how many people use it in their practice,” he said.
Cystoscopy is used to during a surgery to ensure that no injury has been done to the bladder or the urethra, and the American Urogynecological Society recommends that it be performed during any pelvic reconstructive surgery. A key element of the test is confirming that the ureters are open. By increasing urine flow, furosemide can reduce the time to confirmation. But after conferring with a colleague who used the procedure, Dr. Patton looked for some data to support the practice and couldn’t find any.
Although the cystoscopy itself generally is safe, furosemide can cause hypotension, change in renal function, and even dehydration at higher doses. During the question-and-answer period, one attendee noted these issues and pointed out that furosemide can potentiate renal failure, especially among patients taking cephalosporins. “If you’re going to do this sort of trial, you have to consider potential adverse events. A single dose is probably not going to [cause an issue], but in the context of a study you want to monitor the adverse events that have been reported,” this attendee said.
The researchers did not observe any of these adverse events during the study, but Dr. Patton noted that the study was not powered to detect them. “We felt that with the low-dose, single-time [exposure], it was appropriate to not worry too much about those side effects,” he replied.
Another potential concern is that the increased urine flow could mask a kink in the ureter by forcing it open.
In the study, his team randomized 145 patients with a planned cystoscopy as part of a procedure to receive 10-mg furosemide (1 cc) or saline (1 cc) during a cystoscopy performed by an attending or a fellow. The median time to confirmation of ureteral patency was 86.5 seconds in the furosemide group, compared with 165.0 seconds in the saline group (difference, 78.5 seconds; P less than .001). The time to the first ureteral jet was 59 seconds versus 74 seconds, respectively (P less than .006). A Kaplan-Meier survival curve analysis also showed a significant improvement in time to ureteral patency confirmation (log-rank P less than .001).
The study was not funded. Dr. Patton has no relevant financial disclosures.
SOURCE: Patton S et al. SGS 2019, Abstract 10.
TUCSON, ARIZ. – according to results from a new randomized, controlled trial.
“It does make a difference, but is that really a [meaningful] difference? Every medication has adverse effects, so is it worth that extra time [savings] to take on that potential for side effects? It highlights the importance of statistical significance versus clinical significance, and I think [the clinical significance] can just be answered by each individual physician,” Simon Patton, MD, said in an interview.
Dr. Patton is a urogynecologist at Ascension Via Christi Medical Group in Wichita, Kan. He presented the study, which was conducted during his time as a fellow at the University of South Florida, Tampa, at the annual scientific meeting of the Society of Gynecologic Surgeons. Dr. Patton isn’t sure just how often physicians use furosemide during routine cystoscopy. “It would be great to do a survey to find out how many people use it in their practice,” he said.
Cystoscopy is used to during a surgery to ensure that no injury has been done to the bladder or the urethra, and the American Urogynecological Society recommends that it be performed during any pelvic reconstructive surgery. A key element of the test is confirming that the ureters are open. By increasing urine flow, furosemide can reduce the time to confirmation. But after conferring with a colleague who used the procedure, Dr. Patton looked for some data to support the practice and couldn’t find any.
Although the cystoscopy itself generally is safe, furosemide can cause hypotension, change in renal function, and even dehydration at higher doses. During the question-and-answer period, one attendee noted these issues and pointed out that furosemide can potentiate renal failure, especially among patients taking cephalosporins. “If you’re going to do this sort of trial, you have to consider potential adverse events. A single dose is probably not going to [cause an issue], but in the context of a study you want to monitor the adverse events that have been reported,” this attendee said.
The researchers did not observe any of these adverse events during the study, but Dr. Patton noted that the study was not powered to detect them. “We felt that with the low-dose, single-time [exposure], it was appropriate to not worry too much about those side effects,” he replied.
Another potential concern is that the increased urine flow could mask a kink in the ureter by forcing it open.
In the study, his team randomized 145 patients with a planned cystoscopy as part of a procedure to receive 10-mg furosemide (1 cc) or saline (1 cc) during a cystoscopy performed by an attending or a fellow. The median time to confirmation of ureteral patency was 86.5 seconds in the furosemide group, compared with 165.0 seconds in the saline group (difference, 78.5 seconds; P less than .001). The time to the first ureteral jet was 59 seconds versus 74 seconds, respectively (P less than .006). A Kaplan-Meier survival curve analysis also showed a significant improvement in time to ureteral patency confirmation (log-rank P less than .001).
The study was not funded. Dr. Patton has no relevant financial disclosures.
SOURCE: Patton S et al. SGS 2019, Abstract 10.
TUCSON, ARIZ. – according to results from a new randomized, controlled trial.
“It does make a difference, but is that really a [meaningful] difference? Every medication has adverse effects, so is it worth that extra time [savings] to take on that potential for side effects? It highlights the importance of statistical significance versus clinical significance, and I think [the clinical significance] can just be answered by each individual physician,” Simon Patton, MD, said in an interview.
Dr. Patton is a urogynecologist at Ascension Via Christi Medical Group in Wichita, Kan. He presented the study, which was conducted during his time as a fellow at the University of South Florida, Tampa, at the annual scientific meeting of the Society of Gynecologic Surgeons. Dr. Patton isn’t sure just how often physicians use furosemide during routine cystoscopy. “It would be great to do a survey to find out how many people use it in their practice,” he said.
Cystoscopy is used to during a surgery to ensure that no injury has been done to the bladder or the urethra, and the American Urogynecological Society recommends that it be performed during any pelvic reconstructive surgery. A key element of the test is confirming that the ureters are open. By increasing urine flow, furosemide can reduce the time to confirmation. But after conferring with a colleague who used the procedure, Dr. Patton looked for some data to support the practice and couldn’t find any.
Although the cystoscopy itself generally is safe, furosemide can cause hypotension, change in renal function, and even dehydration at higher doses. During the question-and-answer period, one attendee noted these issues and pointed out that furosemide can potentiate renal failure, especially among patients taking cephalosporins. “If you’re going to do this sort of trial, you have to consider potential adverse events. A single dose is probably not going to [cause an issue], but in the context of a study you want to monitor the adverse events that have been reported,” this attendee said.
The researchers did not observe any of these adverse events during the study, but Dr. Patton noted that the study was not powered to detect them. “We felt that with the low-dose, single-time [exposure], it was appropriate to not worry too much about those side effects,” he replied.
Another potential concern is that the increased urine flow could mask a kink in the ureter by forcing it open.
In the study, his team randomized 145 patients with a planned cystoscopy as part of a procedure to receive 10-mg furosemide (1 cc) or saline (1 cc) during a cystoscopy performed by an attending or a fellow. The median time to confirmation of ureteral patency was 86.5 seconds in the furosemide group, compared with 165.0 seconds in the saline group (difference, 78.5 seconds; P less than .001). The time to the first ureteral jet was 59 seconds versus 74 seconds, respectively (P less than .006). A Kaplan-Meier survival curve analysis also showed a significant improvement in time to ureteral patency confirmation (log-rank P less than .001).
The study was not funded. Dr. Patton has no relevant financial disclosures.
SOURCE: Patton S et al. SGS 2019, Abstract 10.
REPORTING FROM SGS 2019
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
In endometrial cancer and SUI, concomitant surgery improves outcomes
TUCSON, ARIZ. – according to a study examining the effects of an SUI screen among endometrial cancer patients.
An estimated 40%-80% of women with endometrial cancer experience SUI. The malignancy often is caught early enough to be treated with curative intent, and that is leading physicians and patients to think more about quality of life outcomes.
And yet, few patients receive concomitant surgery. Twenty percent of the women in the current study opted for concomitant surgeries, yet large database studies show the frequency of concomitant surgeries is about 2.5%. “There’s huge room for improvement in this area. The take-home message is that this is prevalent, this is doable, and this is something that could truly benefit this population,” Evelyn Hall, MD, said in an interview. Dr. Hall is a fellow in female pelvic medicine and reconstructive medicine at Brown University, Providence, R.I. She presented the study at the annual scientific meeting of the Society of Gynecologic Surgeons.
It’s not entirely surprising that SUI tends to be overlooked in patients with endometrial cancer. After all, they are going through a life-changing medical diagnosis, and oncologists are laser focused on achieving a cure when possible. But a bigger picture view, especially in light of the high cure rate for endometrial cancer when detected early, should encourage physicians to think differently about patient management.
The biggest trick may be incorporating concomitant surgeries into the surgical work flow. “It can be challenging logistically. It requires surgical planning and coordination between the two surgeons,” said Dr. Hall. But she said the experience at Brown University showed that it was possible with some patience. “It took a while to get the balls rolling, but once we figured out [it] worked for our institution, we’ve seen a continued uptake,” she said.
An important remaining question is the safety of the concomitant surgeries. Dr. Hall did not report any between-group differences in her presentation, but analysis is ongoing. They found a statistically significant increase in the number of readmissions among the concomitant surgery group, but most were deemed unlikely to be related to concomitant surgery.
In the study, 1,322 endometrial surgical candidates were screened for SUI, and 53% tested positive. Of these, 556 patients were offered concomitant surgical or nonsurgical SUI treatment: 21% chose concomitant surgery, 19% chose nonsurgical SUI treatment, and 60% of patients opted for no SUI treatment.
At 6 months after surgery, the concomitant surgery group was more likely to have a Urinary Distress Inventory (UDI)–Stress score of 0 than were those who were treated nonsurgically (odds ratio, 2.8; P = .0001) and those in the no-treatment group (OR, 3.7; P less than .0001). The concomitant group also was more likely to have a surgical site infection (SSI) score of 0 than was the nonsurgical group (OR, 2.9; P = .0008) and the no-treatment group (OR, 2.7; P less than .0001). Severe/very severe SSI scores occurred in 57% of the concomitant group at baseline, and this frequency dropped to 14% at 6 weeks (P less than .0001).
The study was funded by the Patient-Centered Outcomes Research Institute. Dr. Hall has no relevant financial disclosures.
SOURCE: Hall E et al. SGS 2019, oral presentation 12.
TUCSON, ARIZ. – according to a study examining the effects of an SUI screen among endometrial cancer patients.
An estimated 40%-80% of women with endometrial cancer experience SUI. The malignancy often is caught early enough to be treated with curative intent, and that is leading physicians and patients to think more about quality of life outcomes.
And yet, few patients receive concomitant surgery. Twenty percent of the women in the current study opted for concomitant surgeries, yet large database studies show the frequency of concomitant surgeries is about 2.5%. “There’s huge room for improvement in this area. The take-home message is that this is prevalent, this is doable, and this is something that could truly benefit this population,” Evelyn Hall, MD, said in an interview. Dr. Hall is a fellow in female pelvic medicine and reconstructive medicine at Brown University, Providence, R.I. She presented the study at the annual scientific meeting of the Society of Gynecologic Surgeons.
It’s not entirely surprising that SUI tends to be overlooked in patients with endometrial cancer. After all, they are going through a life-changing medical diagnosis, and oncologists are laser focused on achieving a cure when possible. But a bigger picture view, especially in light of the high cure rate for endometrial cancer when detected early, should encourage physicians to think differently about patient management.
The biggest trick may be incorporating concomitant surgeries into the surgical work flow. “It can be challenging logistically. It requires surgical planning and coordination between the two surgeons,” said Dr. Hall. But she said the experience at Brown University showed that it was possible with some patience. “It took a while to get the balls rolling, but once we figured out [it] worked for our institution, we’ve seen a continued uptake,” she said.
An important remaining question is the safety of the concomitant surgeries. Dr. Hall did not report any between-group differences in her presentation, but analysis is ongoing. They found a statistically significant increase in the number of readmissions among the concomitant surgery group, but most were deemed unlikely to be related to concomitant surgery.
In the study, 1,322 endometrial surgical candidates were screened for SUI, and 53% tested positive. Of these, 556 patients were offered concomitant surgical or nonsurgical SUI treatment: 21% chose concomitant surgery, 19% chose nonsurgical SUI treatment, and 60% of patients opted for no SUI treatment.
At 6 months after surgery, the concomitant surgery group was more likely to have a Urinary Distress Inventory (UDI)–Stress score of 0 than were those who were treated nonsurgically (odds ratio, 2.8; P = .0001) and those in the no-treatment group (OR, 3.7; P less than .0001). The concomitant group also was more likely to have a surgical site infection (SSI) score of 0 than was the nonsurgical group (OR, 2.9; P = .0008) and the no-treatment group (OR, 2.7; P less than .0001). Severe/very severe SSI scores occurred in 57% of the concomitant group at baseline, and this frequency dropped to 14% at 6 weeks (P less than .0001).
The study was funded by the Patient-Centered Outcomes Research Institute. Dr. Hall has no relevant financial disclosures.
SOURCE: Hall E et al. SGS 2019, oral presentation 12.
TUCSON, ARIZ. – according to a study examining the effects of an SUI screen among endometrial cancer patients.
An estimated 40%-80% of women with endometrial cancer experience SUI. The malignancy often is caught early enough to be treated with curative intent, and that is leading physicians and patients to think more about quality of life outcomes.
And yet, few patients receive concomitant surgery. Twenty percent of the women in the current study opted for concomitant surgeries, yet large database studies show the frequency of concomitant surgeries is about 2.5%. “There’s huge room for improvement in this area. The take-home message is that this is prevalent, this is doable, and this is something that could truly benefit this population,” Evelyn Hall, MD, said in an interview. Dr. Hall is a fellow in female pelvic medicine and reconstructive medicine at Brown University, Providence, R.I. She presented the study at the annual scientific meeting of the Society of Gynecologic Surgeons.
It’s not entirely surprising that SUI tends to be overlooked in patients with endometrial cancer. After all, they are going through a life-changing medical diagnosis, and oncologists are laser focused on achieving a cure when possible. But a bigger picture view, especially in light of the high cure rate for endometrial cancer when detected early, should encourage physicians to think differently about patient management.
The biggest trick may be incorporating concomitant surgeries into the surgical work flow. “It can be challenging logistically. It requires surgical planning and coordination between the two surgeons,” said Dr. Hall. But she said the experience at Brown University showed that it was possible with some patience. “It took a while to get the balls rolling, but once we figured out [it] worked for our institution, we’ve seen a continued uptake,” she said.
An important remaining question is the safety of the concomitant surgeries. Dr. Hall did not report any between-group differences in her presentation, but analysis is ongoing. They found a statistically significant increase in the number of readmissions among the concomitant surgery group, but most were deemed unlikely to be related to concomitant surgery.
In the study, 1,322 endometrial surgical candidates were screened for SUI, and 53% tested positive. Of these, 556 patients were offered concomitant surgical or nonsurgical SUI treatment: 21% chose concomitant surgery, 19% chose nonsurgical SUI treatment, and 60% of patients opted for no SUI treatment.
At 6 months after surgery, the concomitant surgery group was more likely to have a Urinary Distress Inventory (UDI)–Stress score of 0 than were those who were treated nonsurgically (odds ratio, 2.8; P = .0001) and those in the no-treatment group (OR, 3.7; P less than .0001). The concomitant group also was more likely to have a surgical site infection (SSI) score of 0 than was the nonsurgical group (OR, 2.9; P = .0008) and the no-treatment group (OR, 2.7; P less than .0001). Severe/very severe SSI scores occurred in 57% of the concomitant group at baseline, and this frequency dropped to 14% at 6 weeks (P less than .0001).
The study was funded by the Patient-Centered Outcomes Research Institute. Dr. Hall has no relevant financial disclosures.
SOURCE: Hall E et al. SGS 2019, oral presentation 12.
REPORTING FROM SGS 2019
Stress incontinence surgery improves sexual dysfunction
TUCSON, ARIZ. –
The finding comes from a secondary analysis of two randomized, controlled trials comparing Burch colposuspension, autologous fascial slings, retropubic midurethral polypropylene slings, and transobturator midurethral polypropylene slings. The analysis looked at outcomes at 24 months after surgery. Stephanie Glass Clark, MD, a resident at Virginia Commonwealth University, Richmond, presented the results at the annual scientific meeting of the Society of Gynecologic Surgeons.
In the secondary analysis of the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) and the Trial of Midurethral Slings (TOMUS) trials, Dr. Clark and her fellow researchers looked at the effect of surgical failure on sexual dysfunction outcomes. Subjective failure was defined as self-reported SUI symptoms or self-reported leakage by 3-day voiding diary beyond 3 months after the surgery. Objective failure was defined as any treatment for SUI after the surgery or a positive stress test or pad test beyond 3 months after the surgery.
Participants were excluded from the two studies if they were sexually inactive in the previous 6 months at baseline, at 12 months post baseline, or at 24 months. The studies employed the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), which had 12 questions with scores ranging from 0 to 4. The secondary analysis sample included 488 women from SISTEr and 436 women from TOMUS.
There were some baseline differences among groups between the two trials, including vaginal deliveries, race/ethnicity, stage of prolapse, and concomitant surgeries performed at time of the anti-incontinence procedure.
All four surgeries were associated with improvements in sexual function, with no statistically significant between-group differences. Mean PISQ-12 scores improved from a range of 31-33 to a range of 36-38 at 24 months. Although there is no published minimum important difference for PISQ-12 scores, an improvement of at least one-half of a standard deviation is generally accepted as clinically meaningful. “In this case, the standard deviation at baseline was just under 3 and so the improvement of each treatment group by more than 1.5 is a clinically meaningful improvement in their sexual function,” Dr. Clark said.
“Sexual dysfunction is a much more common problem than we previously thought, so we’ve been trying to figure out if patients with pelvic floor disorders like stress incontinence are going to have any improvement in sexual dysfunction by surgically treating their stress incontinence. Previously published data had been pretty conflicting,” Dr. Clark added in an interview.
That previous research was mostly retrospective and could have been impacted by patient selection bias. By analyzing clinical trials, the researchers hoped to test their idea that the pelvic floor symptoms themselves may be key to sexual dysfunction and that treating it surgically would improve matters.
The positive result is encouraging, but it still leaves unanswered questions about the mechanism behind the relationship. Dr. Clark wondered whether leaking urine leakage during sex might be the culprit, or whether it is fear or shame associated with the condition.
The answer may come from further analysis of women who were sexually inactive at baseline, but became sexually active over the course of the studies. “I think looking at that patient population in particular is going to be an interesting area of research. Is it that it was completely related to their pelvic floor disorder, and then we fixed it [so] they could have a more fulfilling sexual life?” speculated Dr. Clark.
The study received some funding from the National Institutes of Health. Dr. Clark reported no relevant financial disclosures.
SOURCE: Clark SG et al. SGS 2019, Oral Presentation 11.
TUCSON, ARIZ. –
The finding comes from a secondary analysis of two randomized, controlled trials comparing Burch colposuspension, autologous fascial slings, retropubic midurethral polypropylene slings, and transobturator midurethral polypropylene slings. The analysis looked at outcomes at 24 months after surgery. Stephanie Glass Clark, MD, a resident at Virginia Commonwealth University, Richmond, presented the results at the annual scientific meeting of the Society of Gynecologic Surgeons.
In the secondary analysis of the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) and the Trial of Midurethral Slings (TOMUS) trials, Dr. Clark and her fellow researchers looked at the effect of surgical failure on sexual dysfunction outcomes. Subjective failure was defined as self-reported SUI symptoms or self-reported leakage by 3-day voiding diary beyond 3 months after the surgery. Objective failure was defined as any treatment for SUI after the surgery or a positive stress test or pad test beyond 3 months after the surgery.
Participants were excluded from the two studies if they were sexually inactive in the previous 6 months at baseline, at 12 months post baseline, or at 24 months. The studies employed the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), which had 12 questions with scores ranging from 0 to 4. The secondary analysis sample included 488 women from SISTEr and 436 women from TOMUS.
There were some baseline differences among groups between the two trials, including vaginal deliveries, race/ethnicity, stage of prolapse, and concomitant surgeries performed at time of the anti-incontinence procedure.
All four surgeries were associated with improvements in sexual function, with no statistically significant between-group differences. Mean PISQ-12 scores improved from a range of 31-33 to a range of 36-38 at 24 months. Although there is no published minimum important difference for PISQ-12 scores, an improvement of at least one-half of a standard deviation is generally accepted as clinically meaningful. “In this case, the standard deviation at baseline was just under 3 and so the improvement of each treatment group by more than 1.5 is a clinically meaningful improvement in their sexual function,” Dr. Clark said.
“Sexual dysfunction is a much more common problem than we previously thought, so we’ve been trying to figure out if patients with pelvic floor disorders like stress incontinence are going to have any improvement in sexual dysfunction by surgically treating their stress incontinence. Previously published data had been pretty conflicting,” Dr. Clark added in an interview.
That previous research was mostly retrospective and could have been impacted by patient selection bias. By analyzing clinical trials, the researchers hoped to test their idea that the pelvic floor symptoms themselves may be key to sexual dysfunction and that treating it surgically would improve matters.
The positive result is encouraging, but it still leaves unanswered questions about the mechanism behind the relationship. Dr. Clark wondered whether leaking urine leakage during sex might be the culprit, or whether it is fear or shame associated with the condition.
The answer may come from further analysis of women who were sexually inactive at baseline, but became sexually active over the course of the studies. “I think looking at that patient population in particular is going to be an interesting area of research. Is it that it was completely related to their pelvic floor disorder, and then we fixed it [so] they could have a more fulfilling sexual life?” speculated Dr. Clark.
The study received some funding from the National Institutes of Health. Dr. Clark reported no relevant financial disclosures.
SOURCE: Clark SG et al. SGS 2019, Oral Presentation 11.
TUCSON, ARIZ. –
The finding comes from a secondary analysis of two randomized, controlled trials comparing Burch colposuspension, autologous fascial slings, retropubic midurethral polypropylene slings, and transobturator midurethral polypropylene slings. The analysis looked at outcomes at 24 months after surgery. Stephanie Glass Clark, MD, a resident at Virginia Commonwealth University, Richmond, presented the results at the annual scientific meeting of the Society of Gynecologic Surgeons.
In the secondary analysis of the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr) and the Trial of Midurethral Slings (TOMUS) trials, Dr. Clark and her fellow researchers looked at the effect of surgical failure on sexual dysfunction outcomes. Subjective failure was defined as self-reported SUI symptoms or self-reported leakage by 3-day voiding diary beyond 3 months after the surgery. Objective failure was defined as any treatment for SUI after the surgery or a positive stress test or pad test beyond 3 months after the surgery.
Participants were excluded from the two studies if they were sexually inactive in the previous 6 months at baseline, at 12 months post baseline, or at 24 months. The studies employed the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), which had 12 questions with scores ranging from 0 to 4. The secondary analysis sample included 488 women from SISTEr and 436 women from TOMUS.
There were some baseline differences among groups between the two trials, including vaginal deliveries, race/ethnicity, stage of prolapse, and concomitant surgeries performed at time of the anti-incontinence procedure.
All four surgeries were associated with improvements in sexual function, with no statistically significant between-group differences. Mean PISQ-12 scores improved from a range of 31-33 to a range of 36-38 at 24 months. Although there is no published minimum important difference for PISQ-12 scores, an improvement of at least one-half of a standard deviation is generally accepted as clinically meaningful. “In this case, the standard deviation at baseline was just under 3 and so the improvement of each treatment group by more than 1.5 is a clinically meaningful improvement in their sexual function,” Dr. Clark said.
“Sexual dysfunction is a much more common problem than we previously thought, so we’ve been trying to figure out if patients with pelvic floor disorders like stress incontinence are going to have any improvement in sexual dysfunction by surgically treating their stress incontinence. Previously published data had been pretty conflicting,” Dr. Clark added in an interview.
That previous research was mostly retrospective and could have been impacted by patient selection bias. By analyzing clinical trials, the researchers hoped to test their idea that the pelvic floor symptoms themselves may be key to sexual dysfunction and that treating it surgically would improve matters.
The positive result is encouraging, but it still leaves unanswered questions about the mechanism behind the relationship. Dr. Clark wondered whether leaking urine leakage during sex might be the culprit, or whether it is fear or shame associated with the condition.
The answer may come from further analysis of women who were sexually inactive at baseline, but became sexually active over the course of the studies. “I think looking at that patient population in particular is going to be an interesting area of research. Is it that it was completely related to their pelvic floor disorder, and then we fixed it [so] they could have a more fulfilling sexual life?” speculated Dr. Clark.
The study received some funding from the National Institutes of Health. Dr. Clark reported no relevant financial disclosures.
SOURCE: Clark SG et al. SGS 2019, Oral Presentation 11.
REPORTING FROM SGS 2019
Older women have good functional recovery after POP surgery
TUCSON, ARIZ. – according to a new study.
Functional status was defined as the ability to perform activities essential to self-care, independent living, and recreation.
Patients with the highest level of function at baseline actually had a slight decrease in functionality scores, although this difference was not clinically meaningful.
“We can tell patients: You’re high functioning, your prolapse is bothering you in other ways, but we’re going to keep you as high functioning as you are now. I think that’s really important for older women who are retired and want to stay active. They want to make sure they don’t have a surgery that’s going to make them less so,” Daniel Lee, MD, of the University of Pennsylvania, Philadelphia, said in an interview. Dr. Lee presented the study at the annual scientific meeting of the Society of Gynecologic Surgeons.
The study used data from multiple centers across the United States and a range of patient ethnicities. “That helped strengthen the conclusions,” Dr. Lee said. Most previous studies used generalized questionnaires rather than functional outcome questionnaires to determine patient outcomes.
One confounder is the potential presence of cognitive dysfunction, which can occur sometimes in older women following surgery. The study relied on surveys and excluded patients who weren’t able to understand them. Two patients were much worse after the surgery, and Dr. Lee speculated that cognitive dysfunction could have been the cause, although the team could not confirm that. “There’s a possibility that preexisting dementia or cognitive dysfunction could be unmasked by the surgery,” he said. The team is working to incorporate accelerometers to more objectively measure outcomes and will soon publish a feasibility study of their use in older women with cognitive dysfunction.
One limitation of the study was that it excluded women who were considered poor candidates for surgery. But that also suggests that patient selection is working as intended. “I think it just shows that surgeons do a very good job of figuring out who is a good surgical candidate, that they turn out to be better off [functionally] or that their prolapse gets improved,” Dr. Lee said.
The researchers analyzed questionnaire data from 176 women. The mean age was 72 years, and mean body mass index was 27 kg/m2; 87% of the women were Caucasian and 10% were black. Using the Activities Assessment Scale (AAS), which covers sedentary, ambulatory, and work/exercise domains, as well as the Patient Health Questionnaire to measure depression, the researchers found that, by 3 months, 59% of patients had an improved functional status, 35% had returned to within one standard deviation of baseline, and 6% had worsened, compared with their baseline scores.
Patients in the improved group started at a mean baseline total AAS score of 85 and improved to 100 at 3 months. Those who returned to baseline started at 100 on average and returned to 100 at 3 months, while those in the worsened group had a mean baseline score of 100 and a mean score of 93 at 3 months (P less than .001 for all comparisons).
The study was funded by the Fellows Pelvic Research Network. The investigators reported no relevant financial disclosures.
SOURCE: Lee D et al. SGS 2019, Abstract 09.
TUCSON, ARIZ. – according to a new study.
Functional status was defined as the ability to perform activities essential to self-care, independent living, and recreation.
Patients with the highest level of function at baseline actually had a slight decrease in functionality scores, although this difference was not clinically meaningful.
“We can tell patients: You’re high functioning, your prolapse is bothering you in other ways, but we’re going to keep you as high functioning as you are now. I think that’s really important for older women who are retired and want to stay active. They want to make sure they don’t have a surgery that’s going to make them less so,” Daniel Lee, MD, of the University of Pennsylvania, Philadelphia, said in an interview. Dr. Lee presented the study at the annual scientific meeting of the Society of Gynecologic Surgeons.
The study used data from multiple centers across the United States and a range of patient ethnicities. “That helped strengthen the conclusions,” Dr. Lee said. Most previous studies used generalized questionnaires rather than functional outcome questionnaires to determine patient outcomes.
One confounder is the potential presence of cognitive dysfunction, which can occur sometimes in older women following surgery. The study relied on surveys and excluded patients who weren’t able to understand them. Two patients were much worse after the surgery, and Dr. Lee speculated that cognitive dysfunction could have been the cause, although the team could not confirm that. “There’s a possibility that preexisting dementia or cognitive dysfunction could be unmasked by the surgery,” he said. The team is working to incorporate accelerometers to more objectively measure outcomes and will soon publish a feasibility study of their use in older women with cognitive dysfunction.
One limitation of the study was that it excluded women who were considered poor candidates for surgery. But that also suggests that patient selection is working as intended. “I think it just shows that surgeons do a very good job of figuring out who is a good surgical candidate, that they turn out to be better off [functionally] or that their prolapse gets improved,” Dr. Lee said.
The researchers analyzed questionnaire data from 176 women. The mean age was 72 years, and mean body mass index was 27 kg/m2; 87% of the women were Caucasian and 10% were black. Using the Activities Assessment Scale (AAS), which covers sedentary, ambulatory, and work/exercise domains, as well as the Patient Health Questionnaire to measure depression, the researchers found that, by 3 months, 59% of patients had an improved functional status, 35% had returned to within one standard deviation of baseline, and 6% had worsened, compared with their baseline scores.
Patients in the improved group started at a mean baseline total AAS score of 85 and improved to 100 at 3 months. Those who returned to baseline started at 100 on average and returned to 100 at 3 months, while those in the worsened group had a mean baseline score of 100 and a mean score of 93 at 3 months (P less than .001 for all comparisons).
The study was funded by the Fellows Pelvic Research Network. The investigators reported no relevant financial disclosures.
SOURCE: Lee D et al. SGS 2019, Abstract 09.
TUCSON, ARIZ. – according to a new study.
Functional status was defined as the ability to perform activities essential to self-care, independent living, and recreation.
Patients with the highest level of function at baseline actually had a slight decrease in functionality scores, although this difference was not clinically meaningful.
“We can tell patients: You’re high functioning, your prolapse is bothering you in other ways, but we’re going to keep you as high functioning as you are now. I think that’s really important for older women who are retired and want to stay active. They want to make sure they don’t have a surgery that’s going to make them less so,” Daniel Lee, MD, of the University of Pennsylvania, Philadelphia, said in an interview. Dr. Lee presented the study at the annual scientific meeting of the Society of Gynecologic Surgeons.
The study used data from multiple centers across the United States and a range of patient ethnicities. “That helped strengthen the conclusions,” Dr. Lee said. Most previous studies used generalized questionnaires rather than functional outcome questionnaires to determine patient outcomes.
One confounder is the potential presence of cognitive dysfunction, which can occur sometimes in older women following surgery. The study relied on surveys and excluded patients who weren’t able to understand them. Two patients were much worse after the surgery, and Dr. Lee speculated that cognitive dysfunction could have been the cause, although the team could not confirm that. “There’s a possibility that preexisting dementia or cognitive dysfunction could be unmasked by the surgery,” he said. The team is working to incorporate accelerometers to more objectively measure outcomes and will soon publish a feasibility study of their use in older women with cognitive dysfunction.
One limitation of the study was that it excluded women who were considered poor candidates for surgery. But that also suggests that patient selection is working as intended. “I think it just shows that surgeons do a very good job of figuring out who is a good surgical candidate, that they turn out to be better off [functionally] or that their prolapse gets improved,” Dr. Lee said.
The researchers analyzed questionnaire data from 176 women. The mean age was 72 years, and mean body mass index was 27 kg/m2; 87% of the women were Caucasian and 10% were black. Using the Activities Assessment Scale (AAS), which covers sedentary, ambulatory, and work/exercise domains, as well as the Patient Health Questionnaire to measure depression, the researchers found that, by 3 months, 59% of patients had an improved functional status, 35% had returned to within one standard deviation of baseline, and 6% had worsened, compared with their baseline scores.
Patients in the improved group started at a mean baseline total AAS score of 85 and improved to 100 at 3 months. Those who returned to baseline started at 100 on average and returned to 100 at 3 months, while those in the worsened group had a mean baseline score of 100 and a mean score of 93 at 3 months (P less than .001 for all comparisons).
The study was funded by the Fellows Pelvic Research Network. The investigators reported no relevant financial disclosures.
SOURCE: Lee D et al. SGS 2019, Abstract 09.
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
