Urology

The Robotic or Open Radical Cystectomy in Treating Patients With Bladder Cancer trial is an interventional, randomized, phase 2 study recruiting patients with bladder cancer.

Patients who are recruited will undergo either open or robotic radical cystectomy. In open radical cystectomy, the surgeon cuts into the lower abdomen to expose the urinary tract in order to remove the bladder. In robotic radical cystectomy, small cuts are made in the abdomen into which a scope is inserted; with robotic help, the surgeon removes the bladder. It is currently unknown which approach results in fewer complications, better quality of life, and faster recovery time.

Patients are eligible for the study if they are indicated for radical cystectomy, have Tis-T3 urothelial cancer, and meet surgical candidate criteria. Exclusion factors include having a bulky lymphadenopathy, prior pelvic radiation, or uncontrolled coagulopathy.

The primary outcome measure is change in patient-reported quality of life, as reported using the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C30, 1 month post surgery. The secondary outcome measure is change in erectile dysfunction, as measured by the Sexual Health Inventory For Men score, over a follow-up of up to 12 months.

Recruitment ends on Oct. 12, 2019, and the estimated study completion date is Oct. 12, 2020. About 208 participants are expected to be included.

Find more information on the study page at Clinicaltrials.gov.

[email protected]

The Robotic or Open Radical Cystectomy in Treating Patients With Bladder Cancer trial is an interventional, randomized, phase 2 study recruiting patients with bladder cancer.

Patients who are recruited will undergo either open or robotic radical cystectomy. In open radical cystectomy, the surgeon cuts into the lower abdomen to expose the urinary tract in order to remove the bladder. In robotic radical cystectomy, small cuts are made in the abdomen into which a scope is inserted; with robotic help, the surgeon removes the bladder. It is currently unknown which approach results in fewer complications, better quality of life, and faster recovery time.

Patients are eligible for the study if they are indicated for radical cystectomy, have Tis-T3 urothelial cancer, and meet surgical candidate criteria. Exclusion factors include having a bulky lymphadenopathy, prior pelvic radiation, or uncontrolled coagulopathy.

The primary outcome measure is change in patient-reported quality of life, as reported using the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C30, 1 month post surgery. The secondary outcome measure is change in erectile dysfunction, as measured by the Sexual Health Inventory For Men score, over a follow-up of up to 12 months.

Recruitment ends on Oct. 12, 2019, and the estimated study completion date is Oct. 12, 2020. About 208 participants are expected to be included.

Find more information on the study page at Clinicaltrials.gov.

[email protected]

The Robotic or Open Radical Cystectomy in Treating Patients With Bladder Cancer trial is an interventional, randomized, phase 2 study recruiting patients with bladder cancer.

Patients who are recruited will undergo either open or robotic radical cystectomy. In open radical cystectomy, the surgeon cuts into the lower abdomen to expose the urinary tract in order to remove the bladder. In robotic radical cystectomy, small cuts are made in the abdomen into which a scope is inserted; with robotic help, the surgeon removes the bladder. It is currently unknown which approach results in fewer complications, better quality of life, and faster recovery time.

Patients are eligible for the study if they are indicated for radical cystectomy, have Tis-T3 urothelial cancer, and meet surgical candidate criteria. Exclusion factors include having a bulky lymphadenopathy, prior pelvic radiation, or uncontrolled coagulopathy.

The primary outcome measure is change in patient-reported quality of life, as reported using the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C30, 1 month post surgery. The secondary outcome measure is change in erectile dysfunction, as measured by the Sexual Health Inventory For Men score, over a follow-up of up to 12 months.

Recruitment ends on Oct. 12, 2019, and the estimated study completion date is Oct. 12, 2020. About 208 participants are expected to be included.

Find more information on the study page at Clinicaltrials.gov.

[email protected]

LAS VEGAS – A pelvic surgeon brought a bold message to a gathering of gynecologists: There’s a great gap in American care for pelvic floor disorders such as urinary incontinence, and they’re the right physicians to make a difference by treating these common conditions.

Courtesy Cashman Photo

“There are never going to be enough specialists to deal with these problems. This is a natural progression for many of you,” said urogynecologist and pelvic surgeon Mickey M. Karram, MD, in a joint presentation at the Pelvic Anatomy and Gynecologic Surgery Symposium. In fact, he said, “there’s so much disease out there to fix that you may become more overwhelmed.”

Dr. Karram, who has offices in Cincinnati, Beverly Hills, and Orange County, Calif., spoke about female urinary incontinence with obstetrician-gynecologist Beri M. Ridgeway, MD, of Cleveland Clinic. They offered these tips:

Test for stress incontinence

Dr. Karram recommends using a “quick and easy” cystometrogram (CMG) test to “corroborate or refute what the patient thinks is going on” in regard to urinary function. “With this simple test, you’ll get a clear understanding of sensation [to urinate] and of what their fullness and capacity numbers are,” he said. And if you have the patient cough or strain during the test, “you should be able to duplicate a sign of stress incontinence 90% of the time.”

If patients don’t leak when they take this test, there may be another problem such as overactive bladder, a condition that can’t be duplicated via the test, he said.
 

Ask the right questions

When it comes to identifying when they have urinary difficulties, some patients “say yes to every question we ask,” said Dr. Ridgeway, and they may not be able to distinguish between urgency and leakage.

A better approach is to ask women to provide specific examples of when they have continence issues, she said. It’s also useful to ask patients about what bothers them the most if they have multiple symptoms: Is it urgency (“Gotta go; gotta go”)? Leakage during certain situations like coughing and laughing? “That helps me decide how to go about treating them first and foremost,” she said. “It doesn’t mean you won’t treat both [problems], but it really gives you a reference point of where to start.”

Research suggests that women tend to be more bothered by urge incontinence than stress incontinence, she said, because they can regulate their activities or avoid the stress form.
 

Beware of acute incontinence cases

“If a woman walks in and says ‘Everything was great until a week or two ago, but now I’m living in pads,’ it could be a fecal impaction or a pelvic mass,” Dr. Karram said at the meeting jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.

Discuss the many treatment options

In some cases of incontinence, Dr. Ridgeway said she’ll mention “the array of treatment options, such as pelvic floor physical therapy, bladder retraining, vaginal estrogen, medications, and Botox.”

She added: “I explain that we’ll work together, and sometimes it will take a couple tries, or we’ll try a couple things at once.”

Dr. Ridgeway disclosed consulting for Coloplast and serving as an independent contractor (legal) for Ethicon. Dr. Karram disclosed speaking for Allergan, Astellas Pharma, Coloplast, and Cynosure/Hologic; consulting for Coloplast and Cynosure/Hologic; and receiving royalties from BihlerMed.

LAS VEGAS – A pelvic surgeon brought a bold message to a gathering of gynecologists: There’s a great gap in American care for pelvic floor disorders such as urinary incontinence, and they’re the right physicians to make a difference by treating these common conditions.

Courtesy Cashman Photo

“There are never going to be enough specialists to deal with these problems. This is a natural progression for many of you,” said urogynecologist and pelvic surgeon Mickey M. Karram, MD, in a joint presentation at the Pelvic Anatomy and Gynecologic Surgery Symposium. In fact, he said, “there’s so much disease out there to fix that you may become more overwhelmed.”

Dr. Karram, who has offices in Cincinnati, Beverly Hills, and Orange County, Calif., spoke about female urinary incontinence with obstetrician-gynecologist Beri M. Ridgeway, MD, of Cleveland Clinic. They offered these tips:

Test for stress incontinence

Dr. Karram recommends using a “quick and easy” cystometrogram (CMG) test to “corroborate or refute what the patient thinks is going on” in regard to urinary function. “With this simple test, you’ll get a clear understanding of sensation [to urinate] and of what their fullness and capacity numbers are,” he said. And if you have the patient cough or strain during the test, “you should be able to duplicate a sign of stress incontinence 90% of the time.”

If patients don’t leak when they take this test, there may be another problem such as overactive bladder, a condition that can’t be duplicated via the test, he said.
 

Ask the right questions

When it comes to identifying when they have urinary difficulties, some patients “say yes to every question we ask,” said Dr. Ridgeway, and they may not be able to distinguish between urgency and leakage.

A better approach is to ask women to provide specific examples of when they have continence issues, she said. It’s also useful to ask patients about what bothers them the most if they have multiple symptoms: Is it urgency (“Gotta go; gotta go”)? Leakage during certain situations like coughing and laughing? “That helps me decide how to go about treating them first and foremost,” she said. “It doesn’t mean you won’t treat both [problems], but it really gives you a reference point of where to start.”

Research suggests that women tend to be more bothered by urge incontinence than stress incontinence, she said, because they can regulate their activities or avoid the stress form.
 

Beware of acute incontinence cases

“If a woman walks in and says ‘Everything was great until a week or two ago, but now I’m living in pads,’ it could be a fecal impaction or a pelvic mass,” Dr. Karram said at the meeting jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.

Discuss the many treatment options

In some cases of incontinence, Dr. Ridgeway said she’ll mention “the array of treatment options, such as pelvic floor physical therapy, bladder retraining, vaginal estrogen, medications, and Botox.”

She added: “I explain that we’ll work together, and sometimes it will take a couple tries, or we’ll try a couple things at once.”

Dr. Ridgeway disclosed consulting for Coloplast and serving as an independent contractor (legal) for Ethicon. Dr. Karram disclosed speaking for Allergan, Astellas Pharma, Coloplast, and Cynosure/Hologic; consulting for Coloplast and Cynosure/Hologic; and receiving royalties from BihlerMed.

LAS VEGAS – A pelvic surgeon brought a bold message to a gathering of gynecologists: There’s a great gap in American care for pelvic floor disorders such as urinary incontinence, and they’re the right physicians to make a difference by treating these common conditions.

Courtesy Cashman Photo

“There are never going to be enough specialists to deal with these problems. This is a natural progression for many of you,” said urogynecologist and pelvic surgeon Mickey M. Karram, MD, in a joint presentation at the Pelvic Anatomy and Gynecologic Surgery Symposium. In fact, he said, “there’s so much disease out there to fix that you may become more overwhelmed.”

Dr. Karram, who has offices in Cincinnati, Beverly Hills, and Orange County, Calif., spoke about female urinary incontinence with obstetrician-gynecologist Beri M. Ridgeway, MD, of Cleveland Clinic. They offered these tips:

Test for stress incontinence

Dr. Karram recommends using a “quick and easy” cystometrogram (CMG) test to “corroborate or refute what the patient thinks is going on” in regard to urinary function. “With this simple test, you’ll get a clear understanding of sensation [to urinate] and of what their fullness and capacity numbers are,” he said. And if you have the patient cough or strain during the test, “you should be able to duplicate a sign of stress incontinence 90% of the time.”

If patients don’t leak when they take this test, there may be another problem such as overactive bladder, a condition that can’t be duplicated via the test, he said.
 

Ask the right questions

When it comes to identifying when they have urinary difficulties, some patients “say yes to every question we ask,” said Dr. Ridgeway, and they may not be able to distinguish between urgency and leakage.

A better approach is to ask women to provide specific examples of when they have continence issues, she said. It’s also useful to ask patients about what bothers them the most if they have multiple symptoms: Is it urgency (“Gotta go; gotta go”)? Leakage during certain situations like coughing and laughing? “That helps me decide how to go about treating them first and foremost,” she said. “It doesn’t mean you won’t treat both [problems], but it really gives you a reference point of where to start.”

Research suggests that women tend to be more bothered by urge incontinence than stress incontinence, she said, because they can regulate their activities or avoid the stress form.
 

Beware of acute incontinence cases

“If a woman walks in and says ‘Everything was great until a week or two ago, but now I’m living in pads,’ it could be a fecal impaction or a pelvic mass,” Dr. Karram said at the meeting jointly provided by Global Academy for Medical Education and the University of Cincinnati. Global Academy and this news organization are owned by the same company.

Discuss the many treatment options

In some cases of incontinence, Dr. Ridgeway said she’ll mention “the array of treatment options, such as pelvic floor physical therapy, bladder retraining, vaginal estrogen, medications, and Botox.”

She added: “I explain that we’ll work together, and sometimes it will take a couple tries, or we’ll try a couple things at once.”

Dr. Ridgeway disclosed consulting for Coloplast and serving as an independent contractor (legal) for Ethicon. Dr. Karram disclosed speaking for Allergan, Astellas Pharma, Coloplast, and Cynosure/Hologic; consulting for Coloplast and Cynosure/Hologic; and receiving royalties from BihlerMed.

Urinary retention following laparoscopic total extraperitoneal (TEP) inguinal hernia repair was more likely in patients aged more than 60 years, patients with benign prostatic hyperplasia, and patients with a decreased body mass index, according to findings published in the Journal of Surgical Research.

Courtesy Wikimedia Commons/Samuel Bendet, US Air Force/Creative Commons License

The researchers note that, while laparoscopic TEP is growing in popularity for inguinal hernia repair, postop urinary retention (POUR) is estimated at 2%-30%, but for open procedures, it is estimated at 0.4%-3%. POUR is linked to the development of urinary tract infections and also hospital readmissions. Since TEP may eventually become the norm, the study authors suggest that identifying patients at higher risk for POUR would contribute to the safety and quality of care for this operation.

In a retrospective chart review of 578 patients who had the procedure between 2009 and 2016, patients over age 60 years, patients with benign prostatic hyperplasia, and those with a body mass index (BMI) of less than or equal to 25.8 kg/m² were more likely to develop postoperative urinary retention (POUR). Patients with these risk factors were also more likely to develop a urinary tract infection within 30 days, reported Daniel Roadman, a medical student in the department of surgery at Medical College of Wisconsin in Milwaukee, and coauthors.

Investigators conducted a retrospective chart review of patients 18 years of age or older with a direct, indirect, and/or femoral inguinal hernia. POUR was defined as “inability to void spontaneously prior to hospital discharge, requiring straight or indwelling catheter placement,” the authors wrote.

Patients were required to void before being discharged. For patients unable to void, an indwelling catheter was placed and removed the following morning. Patients still unable to void at this point were discharged with an indwelling catheter and scheduled for follow-up within 1 week.

POUR occurred in 64 of the 578 patients (11.1%), and was significantly associated with benign prostatic hyperplasia, age of 60 years or older, development of urinary tract infection (UTI) within 30 days, and decreased BMI. Patients with POUR had increased incidence of UTI (6.3%), compared with patients without POUR (0.6%; P less than .0001).

Among patients who developed POUR, 54 (84.3%) were admitted for overnight observation with a stay of approximately 1.5 days. Three of these patients (5.6%) had a straight catheterization, and 51 (94.4%) had an indwelling urinary catheter placed. Two patients developed a UTI.

Of the 10 patients discharged home, six (60%) returned to the emergency department for catheterization; two (33.3%) patients had straight catheterization, and four (66.7%) were discharged home with an indwelling catheter. Two of these patients developed a UTI. In both groups, all patients who developed a UTI had an indwelling catheter placed, Mr. Roadman and colleagues reported.

During the study period, institutional protocol changed from routine intraoperative urinary catheterization to catheterization per surgeon discretion, though this did not affect POUR incidence.

“This is the first study to show a significant increase in UTI within 30 days after POUR,” the authors wrote. “Urinary stasis within the bladder due to the inability to void could lead to increased bacterial load and risk of infection.”

“It is important for providers, especially surgeons, to understand the risk of POUR and therefore increased risk of UTI after laparoscopic TEP inguinal hernia repair,” they added. “Identifying patients at higher risk … can help with patient education and expectations.”

No disclosures were reported by the study authors.
 

SOURCE: Roadman D et al. J Surg Res. 2018;11(231):309-15.

Urinary retention following laparoscopic total extraperitoneal (TEP) inguinal hernia repair was more likely in patients aged more than 60 years, patients with benign prostatic hyperplasia, and patients with a decreased body mass index, according to findings published in the Journal of Surgical Research.

Courtesy Wikimedia Commons/Samuel Bendet, US Air Force/Creative Commons License

The researchers note that, while laparoscopic TEP is growing in popularity for inguinal hernia repair, postop urinary retention (POUR) is estimated at 2%-30%, but for open procedures, it is estimated at 0.4%-3%. POUR is linked to the development of urinary tract infections and also hospital readmissions. Since TEP may eventually become the norm, the study authors suggest that identifying patients at higher risk for POUR would contribute to the safety and quality of care for this operation.

In a retrospective chart review of 578 patients who had the procedure between 2009 and 2016, patients over age 60 years, patients with benign prostatic hyperplasia, and those with a body mass index (BMI) of less than or equal to 25.8 kg/m² were more likely to develop postoperative urinary retention (POUR). Patients with these risk factors were also more likely to develop a urinary tract infection within 30 days, reported Daniel Roadman, a medical student in the department of surgery at Medical College of Wisconsin in Milwaukee, and coauthors.

Investigators conducted a retrospective chart review of patients 18 years of age or older with a direct, indirect, and/or femoral inguinal hernia. POUR was defined as “inability to void spontaneously prior to hospital discharge, requiring straight or indwelling catheter placement,” the authors wrote.

Patients were required to void before being discharged. For patients unable to void, an indwelling catheter was placed and removed the following morning. Patients still unable to void at this point were discharged with an indwelling catheter and scheduled for follow-up within 1 week.

POUR occurred in 64 of the 578 patients (11.1%), and was significantly associated with benign prostatic hyperplasia, age of 60 years or older, development of urinary tract infection (UTI) within 30 days, and decreased BMI. Patients with POUR had increased incidence of UTI (6.3%), compared with patients without POUR (0.6%; P less than .0001).

Among patients who developed POUR, 54 (84.3%) were admitted for overnight observation with a stay of approximately 1.5 days. Three of these patients (5.6%) had a straight catheterization, and 51 (94.4%) had an indwelling urinary catheter placed. Two patients developed a UTI.

Of the 10 patients discharged home, six (60%) returned to the emergency department for catheterization; two (33.3%) patients had straight catheterization, and four (66.7%) were discharged home with an indwelling catheter. Two of these patients developed a UTI. In both groups, all patients who developed a UTI had an indwelling catheter placed, Mr. Roadman and colleagues reported.

During the study period, institutional protocol changed from routine intraoperative urinary catheterization to catheterization per surgeon discretion, though this did not affect POUR incidence.

“This is the first study to show a significant increase in UTI within 30 days after POUR,” the authors wrote. “Urinary stasis within the bladder due to the inability to void could lead to increased bacterial load and risk of infection.”

“It is important for providers, especially surgeons, to understand the risk of POUR and therefore increased risk of UTI after laparoscopic TEP inguinal hernia repair,” they added. “Identifying patients at higher risk … can help with patient education and expectations.”

No disclosures were reported by the study authors.
 

SOURCE: Roadman D et al. J Surg Res. 2018;11(231):309-15.

Urinary retention following laparoscopic total extraperitoneal (TEP) inguinal hernia repair was more likely in patients aged more than 60 years, patients with benign prostatic hyperplasia, and patients with a decreased body mass index, according to findings published in the Journal of Surgical Research.

Courtesy Wikimedia Commons/Samuel Bendet, US Air Force/Creative Commons License

The researchers note that, while laparoscopic TEP is growing in popularity for inguinal hernia repair, postop urinary retention (POUR) is estimated at 2%-30%, but for open procedures, it is estimated at 0.4%-3%. POUR is linked to the development of urinary tract infections and also hospital readmissions. Since TEP may eventually become the norm, the study authors suggest that identifying patients at higher risk for POUR would contribute to the safety and quality of care for this operation.

In a retrospective chart review of 578 patients who had the procedure between 2009 and 2016, patients over age 60 years, patients with benign prostatic hyperplasia, and those with a body mass index (BMI) of less than or equal to 25.8 kg/m² were more likely to develop postoperative urinary retention (POUR). Patients with these risk factors were also more likely to develop a urinary tract infection within 30 days, reported Daniel Roadman, a medical student in the department of surgery at Medical College of Wisconsin in Milwaukee, and coauthors.

Investigators conducted a retrospective chart review of patients 18 years of age or older with a direct, indirect, and/or femoral inguinal hernia. POUR was defined as “inability to void spontaneously prior to hospital discharge, requiring straight or indwelling catheter placement,” the authors wrote.

Patients were required to void before being discharged. For patients unable to void, an indwelling catheter was placed and removed the following morning. Patients still unable to void at this point were discharged with an indwelling catheter and scheduled for follow-up within 1 week.

POUR occurred in 64 of the 578 patients (11.1%), and was significantly associated with benign prostatic hyperplasia, age of 60 years or older, development of urinary tract infection (UTI) within 30 days, and decreased BMI. Patients with POUR had increased incidence of UTI (6.3%), compared with patients without POUR (0.6%; P less than .0001).

Among patients who developed POUR, 54 (84.3%) were admitted for overnight observation with a stay of approximately 1.5 days. Three of these patients (5.6%) had a straight catheterization, and 51 (94.4%) had an indwelling urinary catheter placed. Two patients developed a UTI.

Of the 10 patients discharged home, six (60%) returned to the emergency department for catheterization; two (33.3%) patients had straight catheterization, and four (66.7%) were discharged home with an indwelling catheter. Two of these patients developed a UTI. In both groups, all patients who developed a UTI had an indwelling catheter placed, Mr. Roadman and colleagues reported.

During the study period, institutional protocol changed from routine intraoperative urinary catheterization to catheterization per surgeon discretion, though this did not affect POUR incidence.

“This is the first study to show a significant increase in UTI within 30 days after POUR,” the authors wrote. “Urinary stasis within the bladder due to the inability to void could lead to increased bacterial load and risk of infection.”

“It is important for providers, especially surgeons, to understand the risk of POUR and therefore increased risk of UTI after laparoscopic TEP inguinal hernia repair,” they added. “Identifying patients at higher risk … can help with patient education and expectations.”

No disclosures were reported by the study authors.
 

SOURCE: Roadman D et al. J Surg Res. 2018;11(231):309-15.

SAN FRANCISCO – Among men aged younger than 55 years undergoing prostate biopsies, black men were more likely to have a diagnosis of prostate cancer, according to a new study that drew subjects aged 40-54 years from three public and two private hospitals in the Chicago area.

Black race, rather than socioeconomic or clinical factors, appeared to be the strongest nonmodifiable predictor of prostate cancer risk in that age group, the researchers concluded, based on multivariate analyses that examined the association between prostate cancer risk and clinical setting, race, genetically determined West African ancestry, and clinical and socioeconomic risk factors.

For patients of all ages, biopsies were positive in 63.1% of black men, compared with 41.5% of nonblack men (P less than .001). Cancers were also more advanced in black men: 47.5% were Gleason 3+4 in black men, compared with 40% in nonblack men (P less than .001), and 14.4% were Gleason 4+4 in black men, compared with 9.6% in nonblack men (P = .02).

After researchers controlled for other risk factors, black race was associated with heightened risk of prostate cancer diagnosis (OR, 5.66; P = .02), as was family history (OR, 4.98; P = .01).

There was no association between West African ancestry and prostate cancer risk either as a continuous variable or in quartiles.

Limitations of the study include the fact that race was self-reported and that this was a referred population.

The study received funding from the National Institutes of Health and the U.S. Department of Veterans Affairs. Dr. Nettey reported having no financial disclosures.

SOURCE: Nettey OS et al. AUA Annual Meeting. Abstract MP 21-17.

SAN FRANCISCO – Among men aged younger than 55 years undergoing prostate biopsies, black men were more likely to have a diagnosis of prostate cancer, according to a new study that drew subjects aged 40-54 years from three public and two private hospitals in the Chicago area.

Black race, rather than socioeconomic or clinical factors, appeared to be the strongest nonmodifiable predictor of prostate cancer risk in that age group, the researchers concluded, based on multivariate analyses that examined the association between prostate cancer risk and clinical setting, race, genetically determined West African ancestry, and clinical and socioeconomic risk factors.

For patients of all ages, biopsies were positive in 63.1% of black men, compared with 41.5% of nonblack men (P less than .001). Cancers were also more advanced in black men: 47.5% were Gleason 3+4 in black men, compared with 40% in nonblack men (P less than .001), and 14.4% were Gleason 4+4 in black men, compared with 9.6% in nonblack men (P = .02).

After researchers controlled for other risk factors, black race was associated with heightened risk of prostate cancer diagnosis (OR, 5.66; P = .02), as was family history (OR, 4.98; P = .01).

There was no association between West African ancestry and prostate cancer risk either as a continuous variable or in quartiles.

Limitations of the study include the fact that race was self-reported and that this was a referred population.

The study received funding from the National Institutes of Health and the U.S. Department of Veterans Affairs. Dr. Nettey reported having no financial disclosures.

SOURCE: Nettey OS et al. AUA Annual Meeting. Abstract MP 21-17.

SAN FRANCISCO – Among men aged younger than 55 years undergoing prostate biopsies, black men were more likely to have a diagnosis of prostate cancer, according to a new study that drew subjects aged 40-54 years from three public and two private hospitals in the Chicago area.

Black race, rather than socioeconomic or clinical factors, appeared to be the strongest nonmodifiable predictor of prostate cancer risk in that age group, the researchers concluded, based on multivariate analyses that examined the association between prostate cancer risk and clinical setting, race, genetically determined West African ancestry, and clinical and socioeconomic risk factors.

For patients of all ages, biopsies were positive in 63.1% of black men, compared with 41.5% of nonblack men (P less than .001). Cancers were also more advanced in black men: 47.5% were Gleason 3+4 in black men, compared with 40% in nonblack men (P less than .001), and 14.4% were Gleason 4+4 in black men, compared with 9.6% in nonblack men (P = .02).

After researchers controlled for other risk factors, black race was associated with heightened risk of prostate cancer diagnosis (OR, 5.66; P = .02), as was family history (OR, 4.98; P = .01).

There was no association between West African ancestry and prostate cancer risk either as a continuous variable or in quartiles.

Limitations of the study include the fact that race was self-reported and that this was a referred population.

The study received funding from the National Institutes of Health and the U.S. Department of Veterans Affairs. Dr. Nettey reported having no financial disclosures.

SOURCE: Nettey OS et al. AUA Annual Meeting. Abstract MP 21-17.

SAN FRANCISCO – Stress urinary incontinence (SUI) following removal of a mid-urethral sling (MUS) mesh is not necessarily associated with increased risk of postsurgical urinary incontinence, according to a retrospective study at a high-volume, tertiary medical center.

Follow-up procedures occurred more often in women with preoperative urodynamic SUI and less often in women who were stress continent.

Jim Kling/MDedge

Among women who were stress continent, obesity and postmenopausal status were linked to postsurgical SUI. There was no association between postsurgical SUI and the extent of mesh excision or prior revisions.

The study grew out of observations that SUI occurred less often than expected.

“There’s an increasing recognition of complications related to synthetic MUS,” said Janine Oliver, MD, who presented the study at the annual meeting of the American Urological Association. “As mesh removal procedures were being performed, we assumed that the majority of patients, if not all, would be incontinent afterward, since we were removing the sling that was put in to fix stress incontinence in most cases.”

In a patient who would benefit from a complete mesh removal, “the fear that it may lead to a higher risk of urinary incontinence is not a good justification to not do it,” Dr. Oliver said. She did note, however, that the procedures were done by specialists, so findings may not be applicable to general practitioners.

The study was performed while Dr. Oliver was a fellow at the University of California, Los Angeles. She is now with the division of urology at the University of Colorado, Anschutz, in Aurora.

SOURCE: Oliver J et al. AUA Annual Meeting. Abstract PD05-10.

SAN FRANCISCO – Stress urinary incontinence (SUI) following removal of a mid-urethral sling (MUS) mesh is not necessarily associated with increased risk of postsurgical urinary incontinence, according to a retrospective study at a high-volume, tertiary medical center.

Follow-up procedures occurred more often in women with preoperative urodynamic SUI and less often in women who were stress continent.

Jim Kling/MDedge

Among women who were stress continent, obesity and postmenopausal status were linked to postsurgical SUI. There was no association between postsurgical SUI and the extent of mesh excision or prior revisions.

The study grew out of observations that SUI occurred less often than expected.

“There’s an increasing recognition of complications related to synthetic MUS,” said Janine Oliver, MD, who presented the study at the annual meeting of the American Urological Association. “As mesh removal procedures were being performed, we assumed that the majority of patients, if not all, would be incontinent afterward, since we were removing the sling that was put in to fix stress incontinence in most cases.”

In a patient who would benefit from a complete mesh removal, “the fear that it may lead to a higher risk of urinary incontinence is not a good justification to not do it,” Dr. Oliver said. She did note, however, that the procedures were done by specialists, so findings may not be applicable to general practitioners.

The study was performed while Dr. Oliver was a fellow at the University of California, Los Angeles. She is now with the division of urology at the University of Colorado, Anschutz, in Aurora.

SOURCE: Oliver J et al. AUA Annual Meeting. Abstract PD05-10.

SAN FRANCISCO – Stress urinary incontinence (SUI) following removal of a mid-urethral sling (MUS) mesh is not necessarily associated with increased risk of postsurgical urinary incontinence, according to a retrospective study at a high-volume, tertiary medical center.

Follow-up procedures occurred more often in women with preoperative urodynamic SUI and less often in women who were stress continent.

Jim Kling/MDedge

Among women who were stress continent, obesity and postmenopausal status were linked to postsurgical SUI. There was no association between postsurgical SUI and the extent of mesh excision or prior revisions.

The study grew out of observations that SUI occurred less often than expected.

“There’s an increasing recognition of complications related to synthetic MUS,” said Janine Oliver, MD, who presented the study at the annual meeting of the American Urological Association. “As mesh removal procedures were being performed, we assumed that the majority of patients, if not all, would be incontinent afterward, since we were removing the sling that was put in to fix stress incontinence in most cases.”

In a patient who would benefit from a complete mesh removal, “the fear that it may lead to a higher risk of urinary incontinence is not a good justification to not do it,” Dr. Oliver said. She did note, however, that the procedures were done by specialists, so findings may not be applicable to general practitioners.

The study was performed while Dr. Oliver was a fellow at the University of California, Los Angeles. She is now with the division of urology at the University of Colorado, Anschutz, in Aurora.

SOURCE: Oliver J et al. AUA Annual Meeting. Abstract PD05-10.

SAN FRANCISCO – Two concurrent chemoradiation induction regimens had similar safety and efficacy when used as part of a bladder-sparing strategy in patients with muscle-invasive bladder cancer, suggest primary results of the NRG/RTOG 0712 trial. But one offers better patient convenience.

The selective bladder-preservation paradigm entails maximal transurethral resection of the bladder tumor (TURBT) followed by induction radiation and concomitant chemotherapy, lead author John J. Coen, MD, a radiation oncologist with 21st Century Oncology, Providence, Rhode Island, noted at the 2018 Genitourinary Cancers Symposium. Patients then undergo cystoscopy to assess their response.

“A key component of this therapy is close urologic surveillance,” he noted. “This is trimodality therapy with close urologic surveillance, and cystectomy is prompted at the earliest time it’s indicated.”

Clinical implications

“I would have to see more details about the toxicity data for the chemotherapy, the radiosensitizers,” session co-chair Yair Lotan, MD, a professor of urology at the UT Southwestern Medical Center, Dallas, Texas, commented in an interview. “But in general, if you have two equivalent protocols in terms of effectiveness, and one is less toxic or more convenient, that’s always preferable. From the standpoint of coming once a day rather than twice a day to get radiation, if I were a patient, I would prefer that regimen”

Current practice in this patient population likely hinges on where a patient is treated, he said. “Based on the new nonmetastatic muscle-invasive guidelines, many of them would be recommended surgery or possibly chemoradiation protocols, and then there are a lot of factors such as patient preference and outcomes that would probably impact the decision making.”

“Certainly, this study won’t prove standard of care because standard of care in the global picture for a patient with muscle-invasive disease really will depend on a randomized trial of surgery versus radiation or chemoradiation, multimodal therapies,” Dr. Lotan maintained. “Not every patient is even eligible; some patients with hydronephrosis or unresectable disease may not be the best candidates for multimodal therapy. But more information from these types of trials may help clinicians decide which multimodal therapy approach to use.”

Study details

Patients enrolled in NRG/RTOG 0712, a multicenter randomized phase 2 trial supported by the National Cancer Institute, had clinical T2 or T3-4a bladder cancer. Hydronephrosis and obvious lymph node involvement were exclusion criteria.

Like the rate of freedom from metastasis, the rate of complete response after induction therapy was similar for the two arms: 87.9% with twice-daily radiation plus 5-flourouracil-cisplatin and 75.8% with daily radiation plus gemcitabine.

“These rates exceed historical complete response rates, and this is likely a result of improved selection over time and more thorough TURBTs performed over time,” Dr. Coen proposed. “Over the course of multiple successive RTOG trials, our selection criteria have been refined. One excellent example would be that hydronephrosis has been excluded on more contemporary trials, but if you look at older trials, those patients were included.”

The 3-year rate of bladder-intact distant metastasis–free survival was 66.7% and 69%, respectively. “This is a very important endpoint. These results are excellent,” he commented. “And there is really no appreciable difference between the two arms on the actuarial analysis.”

As far as specific treatment failure events in the trial overall, three patients died, eight underwent cystectomy, and eight developed distant metastases. Although numbers were small, these events appeared fairly evenly distributed across arms.

The rate of grade 3 or 4 acute toxicity was 57.6% with twice-daily radiation plus 5-flourouracil-cisplatin and 54.6% with daily radiation plus gemcitabine. The large majority of events were blood and bone marrow toxicity. “It’s quite notable that the rates of GU and GI toxicity were very low,” commented Dr. Coen, who disclosed that he had no relevant conflicts of interest.

SOURCE: Coen, J. et al, 2018 Genitourinary Cancers Symposium, Abstract 408

SAN FRANCISCO – Two concurrent chemoradiation induction regimens had similar safety and efficacy when used as part of a bladder-sparing strategy in patients with muscle-invasive bladder cancer, suggest primary results of the NRG/RTOG 0712 trial. But one offers better patient convenience.

The selective bladder-preservation paradigm entails maximal transurethral resection of the bladder tumor (TURBT) followed by induction radiation and concomitant chemotherapy, lead author John J. Coen, MD, a radiation oncologist with 21st Century Oncology, Providence, Rhode Island, noted at the 2018 Genitourinary Cancers Symposium. Patients then undergo cystoscopy to assess their response.

“A key component of this therapy is close urologic surveillance,” he noted. “This is trimodality therapy with close urologic surveillance, and cystectomy is prompted at the earliest time it’s indicated.”

Clinical implications

“I would have to see more details about the toxicity data for the chemotherapy, the radiosensitizers,” session co-chair Yair Lotan, MD, a professor of urology at the UT Southwestern Medical Center, Dallas, Texas, commented in an interview. “But in general, if you have two equivalent protocols in terms of effectiveness, and one is less toxic or more convenient, that’s always preferable. From the standpoint of coming once a day rather than twice a day to get radiation, if I were a patient, I would prefer that regimen”

Current practice in this patient population likely hinges on where a patient is treated, he said. “Based on the new nonmetastatic muscle-invasive guidelines, many of them would be recommended surgery or possibly chemoradiation protocols, and then there are a lot of factors such as patient preference and outcomes that would probably impact the decision making.”

“Certainly, this study won’t prove standard of care because standard of care in the global picture for a patient with muscle-invasive disease really will depend on a randomized trial of surgery versus radiation or chemoradiation, multimodal therapies,” Dr. Lotan maintained. “Not every patient is even eligible; some patients with hydronephrosis or unresectable disease may not be the best candidates for multimodal therapy. But more information from these types of trials may help clinicians decide which multimodal therapy approach to use.”

Study details

Patients enrolled in NRG/RTOG 0712, a multicenter randomized phase 2 trial supported by the National Cancer Institute, had clinical T2 or T3-4a bladder cancer. Hydronephrosis and obvious lymph node involvement were exclusion criteria.

Like the rate of freedom from metastasis, the rate of complete response after induction therapy was similar for the two arms: 87.9% with twice-daily radiation plus 5-flourouracil-cisplatin and 75.8% with daily radiation plus gemcitabine.

“These rates exceed historical complete response rates, and this is likely a result of improved selection over time and more thorough TURBTs performed over time,” Dr. Coen proposed. “Over the course of multiple successive RTOG trials, our selection criteria have been refined. One excellent example would be that hydronephrosis has been excluded on more contemporary trials, but if you look at older trials, those patients were included.”

The 3-year rate of bladder-intact distant metastasis–free survival was 66.7% and 69%, respectively. “This is a very important endpoint. These results are excellent,” he commented. “And there is really no appreciable difference between the two arms on the actuarial analysis.”

As far as specific treatment failure events in the trial overall, three patients died, eight underwent cystectomy, and eight developed distant metastases. Although numbers were small, these events appeared fairly evenly distributed across arms.

The rate of grade 3 or 4 acute toxicity was 57.6% with twice-daily radiation plus 5-flourouracil-cisplatin and 54.6% with daily radiation plus gemcitabine. The large majority of events were blood and bone marrow toxicity. “It’s quite notable that the rates of GU and GI toxicity were very low,” commented Dr. Coen, who disclosed that he had no relevant conflicts of interest.

SOURCE: Coen, J. et al, 2018 Genitourinary Cancers Symposium, Abstract 408

SAN FRANCISCO – Two concurrent chemoradiation induction regimens had similar safety and efficacy when used as part of a bladder-sparing strategy in patients with muscle-invasive bladder cancer, suggest primary results of the NRG/RTOG 0712 trial. But one offers better patient convenience.

The selective bladder-preservation paradigm entails maximal transurethral resection of the bladder tumor (TURBT) followed by induction radiation and concomitant chemotherapy, lead author John J. Coen, MD, a radiation oncologist with 21st Century Oncology, Providence, Rhode Island, noted at the 2018 Genitourinary Cancers Symposium. Patients then undergo cystoscopy to assess their response.

“A key component of this therapy is close urologic surveillance,” he noted. “This is trimodality therapy with close urologic surveillance, and cystectomy is prompted at the earliest time it’s indicated.”

Clinical implications

“I would have to see more details about the toxicity data for the chemotherapy, the radiosensitizers,” session co-chair Yair Lotan, MD, a professor of urology at the UT Southwestern Medical Center, Dallas, Texas, commented in an interview. “But in general, if you have two equivalent protocols in terms of effectiveness, and one is less toxic or more convenient, that’s always preferable. From the standpoint of coming once a day rather than twice a day to get radiation, if I were a patient, I would prefer that regimen”

Current practice in this patient population likely hinges on where a patient is treated, he said. “Based on the new nonmetastatic muscle-invasive guidelines, many of them would be recommended surgery or possibly chemoradiation protocols, and then there are a lot of factors such as patient preference and outcomes that would probably impact the decision making.”

“Certainly, this study won’t prove standard of care because standard of care in the global picture for a patient with muscle-invasive disease really will depend on a randomized trial of surgery versus radiation or chemoradiation, multimodal therapies,” Dr. Lotan maintained. “Not every patient is even eligible; some patients with hydronephrosis or unresectable disease may not be the best candidates for multimodal therapy. But more information from these types of trials may help clinicians decide which multimodal therapy approach to use.”

Study details

Patients enrolled in NRG/RTOG 0712, a multicenter randomized phase 2 trial supported by the National Cancer Institute, had clinical T2 or T3-4a bladder cancer. Hydronephrosis and obvious lymph node involvement were exclusion criteria.

Like the rate of freedom from metastasis, the rate of complete response after induction therapy was similar for the two arms: 87.9% with twice-daily radiation plus 5-flourouracil-cisplatin and 75.8% with daily radiation plus gemcitabine.

“These rates exceed historical complete response rates, and this is likely a result of improved selection over time and more thorough TURBTs performed over time,” Dr. Coen proposed. “Over the course of multiple successive RTOG trials, our selection criteria have been refined. One excellent example would be that hydronephrosis has been excluded on more contemporary trials, but if you look at older trials, those patients were included.”

The 3-year rate of bladder-intact distant metastasis–free survival was 66.7% and 69%, respectively. “This is a very important endpoint. These results are excellent,” he commented. “And there is really no appreciable difference between the two arms on the actuarial analysis.”

As far as specific treatment failure events in the trial overall, three patients died, eight underwent cystectomy, and eight developed distant metastases. Although numbers were small, these events appeared fairly evenly distributed across arms.

The rate of grade 3 or 4 acute toxicity was 57.6% with twice-daily radiation plus 5-flourouracil-cisplatin and 54.6% with daily radiation plus gemcitabine. The large majority of events were blood and bone marrow toxicity. “It’s quite notable that the rates of GU and GI toxicity were very low,” commented Dr. Coen, who disclosed that he had no relevant conflicts of interest.

SOURCE: Coen, J. et al, 2018 Genitourinary Cancers Symposium, Abstract 408

SAN FRANCISCO – Patients who have undergone nephro-ureterectomy for upper-tract urothelial cancer (UTUC) fare much better if they are given adjuvant chemotherapy, according to the first results of the POUT trial reported at the 2018 Genitourinary Cancers Symposium.

Standard treatment for this rare cancer is radical nephro-ureterectomy followed by surveillance, noted lead author Alison Jane Birtle, MD, MRCP, FRCR, a consultant clinical oncologist at the Rosemere Cancer Centre, Royal Preston Hospital, Preston, United Kingdom. Evidence has been insufficient to recommend adjuvant therapy.

“We know that UTUC shares a similar etiology with bladder cancer, where there is strong evidence for chemotherapy,” she said. “Trials of adjuvant chemotherapy in bladder cancer have been challenging because of cystectomy being a much more morbid operation. So adjuvant chemotherapy after nephro-ureterectomy should be much easier to give because of the less morbid procedure.”

Other viewpoints

“It’s fantastic that we finally have data in upper-tract cancer. However, I worry about how this data is going to be interpreted, and I argue that it should not be considered the standard of care,” session attendee Matthew Campbell, MD, of the MD Anderson Cancer Center, Houston, commented during a question and answer period.

“I believe that this is showing that chemotherapy is very important in this disease, and if anything, it should be moved into the neoadjuvant setting, where more patients will be cisplatin candidates. Though there is challenge with staging upper-tract disease, at MD Anderson, we consider patients with high-grade disease or hydronephrosis to be at high enough risk to consider for neoadjuvant chemotherapy, and that’s been our approach.”

“When we looked at developing POUT, there was a big debate about whether it should be a neoadjuvant or adjuvant study,” Dr. Birtle replied. UK oncologists expressed concern that not all patients have histologic confirmation of UTUC preoperatively; therefore, chemotherapy could lead to overtreatment for some.

“We plan to go back and look at the CT urograms and the diagnostic imaging done prior to surgery just to see if we can be 100% confident in our diagnostic accuracy preoperatively, to see if we would be more confident with a neoadjuvant study,” she added. The investigators have also reviewed data from the British Association of Urological Surgeons on the postoperative dip in GFR. “It didn’t really seem from that 2015 data that there was a huge unmet need for patients postoperatively, where we would have missed them had we not treated them preoperatively,” she said.

On a related note, session attendee Surena Matin, MD, also of MD Anderson, asked “How many patients were potentially precluded because of their GFR, and do you have any data regarding response rates in the carboplatin arm?”

The main reason for exclusion was ineligible pathology and not GFR, according to Dr. Birtle. “This goes back to the previous question of can you be certain that a patient has locally advanced disease prior to nephro-ureterectomy? About 60% of patients who were thought to have muscle-invasive disease ultimately on nephro-ureterectomy didn’t.”

Confidence intervals for chemotherapy benefit in the subgroup given carboplatin were wide and overlapped unity, but still favoring benefit and falling within the overall treatment effect, she said.

Session attendee Joaquim Bellmunt, MD, Dana-Farber Cancer Institute, Boston, noted that the chemotherapy benefit was not significant in that subgroup and also in the subgroups with lymph node–positive disease and with positive margins. “I think that saying … chemotherapy is for everybody based on this trial” is incorrect, he asserted. “It may be good just to tone down the message that this is the new standard of care.” He further questioned the trial’s early stopping, noting that continuing would have provided more information in these patients.

Those subgroups were small, so analyses were underpowered to definitively rule out chemotherapy benefit, according to Dr. Birtle. The investigators had intensive discussion about the recommendation to stop early, because of a goal to determine overall survival impact. Ultimately, “when we saw the data in terms of disease-free survival and metastasis-free survival, the magnitude of the effect was so big that we felt it was uncomfortable and unethical not to offer patients treatment,” she said.

Study details

Patients in POUT’s chemotherapy arm received four cycles of chemotherapy—gemcitabine-cisplatin if their GFR was 50 mL/min or higher, or gemcitabine-carboplatin if their GFR was 30-49 mL/min—starting within 90 days of nephro-ureterectomy.

Of note, approximately 40% of all patients in the trial were aged 70 years or older, including the 5% who were aged 80 years or older. “This is very reassuring for a study of adjuvant platinum-based chemotherapy,” Dr. Birtle commented. Fully 71.2% of the chemotherapy patients received all four planned cycles.

In an intention-to-treat analysis, risk of disease-free survival events (death from any cause, metastasis, or any ureteric or renal bed recurrence) was sharply reduced with chemotherapy versus surveillance (hazard ratio, 0.49; P=.001). The proportion of patients event free at 2 years was 71% in the chemotherapy group and 54% in the surveillance group. Benefit was generally similar across subgroups, and findings were much the same after adjustment for nodal involvement, microscopic margin status, and planned chemotherapy regimen (hazard ratio, 0.47; P=.001).

Risk of metastasis-free survival events was also sharply lower with chemotherapy (hazard ratio, 0.49; P=.002), with a proportion event free at 2 years of 74% in the chemotherapy group and 60% in the surveillance group. These findings were also much the same after adjustment for the above factors (hazard ratio, 0.47; P=.002).

Overall survival tended to be better with chemotherapy than with surveillance (hazard ratio, 0.55), but data are still immature for this endpoint.

The rate of grade 3 or worse adverse events during the treatment period was 53.2% with chemotherapy and 13.5% with surveillance; events with chemotherapy were as expected, with neutropenia, thrombocytopenia, and gastrointestinal events predominating. The rate of febrile neutropenia was 5.7% with gemcitabine-cisplatin and 7.8% with gemcitabine-carboplatin, but there were no neutropenic deaths.

The rate of grade 3 or worse adverse events for the entire trial period was 62.1% with chemotherapy and 24.8% with surveillance.

Data on nephrotoxicity are still being evaluated, according to Dr. Birtle. Only seven patients who started on gemcitabine-cisplatin had to switch to gemcitabine-carboplatin because their GFR fell.

In a related translational study, the investigators are evaluating both the baseline CT urograms and the resected tumors to identify prognostic and predictive markers, she said.

Dr. Birtle disclosed that she receives honoraria from Roche, Janssen, Astellas, and Bayer, and is a consultant to Sanofi-Aventis. The trial was funded by the UK Clinical Trials Awards and Advisory Committee.

SOURCE: Birtle A et al. Genitourinary Cancers Symposium. Abstract 407

SAN FRANCISCO – Patients who have undergone nephro-ureterectomy for upper-tract urothelial cancer (UTUC) fare much better if they are given adjuvant chemotherapy, according to the first results of the POUT trial reported at the 2018 Genitourinary Cancers Symposium.

Standard treatment for this rare cancer is radical nephro-ureterectomy followed by surveillance, noted lead author Alison Jane Birtle, MD, MRCP, FRCR, a consultant clinical oncologist at the Rosemere Cancer Centre, Royal Preston Hospital, Preston, United Kingdom. Evidence has been insufficient to recommend adjuvant therapy.

“We know that UTUC shares a similar etiology with bladder cancer, where there is strong evidence for chemotherapy,” she said. “Trials of adjuvant chemotherapy in bladder cancer have been challenging because of cystectomy being a much more morbid operation. So adjuvant chemotherapy after nephro-ureterectomy should be much easier to give because of the less morbid procedure.”

Other viewpoints

“It’s fantastic that we finally have data in upper-tract cancer. However, I worry about how this data is going to be interpreted, and I argue that it should not be considered the standard of care,” session attendee Matthew Campbell, MD, of the MD Anderson Cancer Center, Houston, commented during a question and answer period.

“I believe that this is showing that chemotherapy is very important in this disease, and if anything, it should be moved into the neoadjuvant setting, where more patients will be cisplatin candidates. Though there is challenge with staging upper-tract disease, at MD Anderson, we consider patients with high-grade disease or hydronephrosis to be at high enough risk to consider for neoadjuvant chemotherapy, and that’s been our approach.”

“When we looked at developing POUT, there was a big debate about whether it should be a neoadjuvant or adjuvant study,” Dr. Birtle replied. UK oncologists expressed concern that not all patients have histologic confirmation of UTUC preoperatively; therefore, chemotherapy could lead to overtreatment for some.

“We plan to go back and look at the CT urograms and the diagnostic imaging done prior to surgery just to see if we can be 100% confident in our diagnostic accuracy preoperatively, to see if we would be more confident with a neoadjuvant study,” she added. The investigators have also reviewed data from the British Association of Urological Surgeons on the postoperative dip in GFR. “It didn’t really seem from that 2015 data that there was a huge unmet need for patients postoperatively, where we would have missed them had we not treated them preoperatively,” she said.

On a related note, session attendee Surena Matin, MD, also of MD Anderson, asked “How many patients were potentially precluded because of their GFR, and do you have any data regarding response rates in the carboplatin arm?”

The main reason for exclusion was ineligible pathology and not GFR, according to Dr. Birtle. “This goes back to the previous question of can you be certain that a patient has locally advanced disease prior to nephro-ureterectomy? About 60% of patients who were thought to have muscle-invasive disease ultimately on nephro-ureterectomy didn’t.”

Confidence intervals for chemotherapy benefit in the subgroup given carboplatin were wide and overlapped unity, but still favoring benefit and falling within the overall treatment effect, she said.

Session attendee Joaquim Bellmunt, MD, Dana-Farber Cancer Institute, Boston, noted that the chemotherapy benefit was not significant in that subgroup and also in the subgroups with lymph node–positive disease and with positive margins. “I think that saying … chemotherapy is for everybody based on this trial” is incorrect, he asserted. “It may be good just to tone down the message that this is the new standard of care.” He further questioned the trial’s early stopping, noting that continuing would have provided more information in these patients.

Those subgroups were small, so analyses were underpowered to definitively rule out chemotherapy benefit, according to Dr. Birtle. The investigators had intensive discussion about the recommendation to stop early, because of a goal to determine overall survival impact. Ultimately, “when we saw the data in terms of disease-free survival and metastasis-free survival, the magnitude of the effect was so big that we felt it was uncomfortable and unethical not to offer patients treatment,” she said.

Study details

Patients in POUT’s chemotherapy arm received four cycles of chemotherapy—gemcitabine-cisplatin if their GFR was 50 mL/min or higher, or gemcitabine-carboplatin if their GFR was 30-49 mL/min—starting within 90 days of nephro-ureterectomy.

Of note, approximately 40% of all patients in the trial were aged 70 years or older, including the 5% who were aged 80 years or older. “This is very reassuring for a study of adjuvant platinum-based chemotherapy,” Dr. Birtle commented. Fully 71.2% of the chemotherapy patients received all four planned cycles.

In an intention-to-treat analysis, risk of disease-free survival events (death from any cause, metastasis, or any ureteric or renal bed recurrence) was sharply reduced with chemotherapy versus surveillance (hazard ratio, 0.49; P=.001). The proportion of patients event free at 2 years was 71% in the chemotherapy group and 54% in the surveillance group. Benefit was generally similar across subgroups, and findings were much the same after adjustment for nodal involvement, microscopic margin status, and planned chemotherapy regimen (hazard ratio, 0.47; P=.001).

Risk of metastasis-free survival events was also sharply lower with chemotherapy (hazard ratio, 0.49; P=.002), with a proportion event free at 2 years of 74% in the chemotherapy group and 60% in the surveillance group. These findings were also much the same after adjustment for the above factors (hazard ratio, 0.47; P=.002).

Overall survival tended to be better with chemotherapy than with surveillance (hazard ratio, 0.55), but data are still immature for this endpoint.

The rate of grade 3 or worse adverse events during the treatment period was 53.2% with chemotherapy and 13.5% with surveillance; events with chemotherapy were as expected, with neutropenia, thrombocytopenia, and gastrointestinal events predominating. The rate of febrile neutropenia was 5.7% with gemcitabine-cisplatin and 7.8% with gemcitabine-carboplatin, but there were no neutropenic deaths.

The rate of grade 3 or worse adverse events for the entire trial period was 62.1% with chemotherapy and 24.8% with surveillance.

Data on nephrotoxicity are still being evaluated, according to Dr. Birtle. Only seven patients who started on gemcitabine-cisplatin had to switch to gemcitabine-carboplatin because their GFR fell.

In a related translational study, the investigators are evaluating both the baseline CT urograms and the resected tumors to identify prognostic and predictive markers, she said.

Dr. Birtle disclosed that she receives honoraria from Roche, Janssen, Astellas, and Bayer, and is a consultant to Sanofi-Aventis. The trial was funded by the UK Clinical Trials Awards and Advisory Committee.

SOURCE: Birtle A et al. Genitourinary Cancers Symposium. Abstract 407

SAN FRANCISCO – Patients who have undergone nephro-ureterectomy for upper-tract urothelial cancer (UTUC) fare much better if they are given adjuvant chemotherapy, according to the first results of the POUT trial reported at the 2018 Genitourinary Cancers Symposium.

Standard treatment for this rare cancer is radical nephro-ureterectomy followed by surveillance, noted lead author Alison Jane Birtle, MD, MRCP, FRCR, a consultant clinical oncologist at the Rosemere Cancer Centre, Royal Preston Hospital, Preston, United Kingdom. Evidence has been insufficient to recommend adjuvant therapy.

“We know that UTUC shares a similar etiology with bladder cancer, where there is strong evidence for chemotherapy,” she said. “Trials of adjuvant chemotherapy in bladder cancer have been challenging because of cystectomy being a much more morbid operation. So adjuvant chemotherapy after nephro-ureterectomy should be much easier to give because of the less morbid procedure.”

Other viewpoints

“It’s fantastic that we finally have data in upper-tract cancer. However, I worry about how this data is going to be interpreted, and I argue that it should not be considered the standard of care,” session attendee Matthew Campbell, MD, of the MD Anderson Cancer Center, Houston, commented during a question and answer period.

“I believe that this is showing that chemotherapy is very important in this disease, and if anything, it should be moved into the neoadjuvant setting, where more patients will be cisplatin candidates. Though there is challenge with staging upper-tract disease, at MD Anderson, we consider patients with high-grade disease or hydronephrosis to be at high enough risk to consider for neoadjuvant chemotherapy, and that’s been our approach.”

“When we looked at developing POUT, there was a big debate about whether it should be a neoadjuvant or adjuvant study,” Dr. Birtle replied. UK oncologists expressed concern that not all patients have histologic confirmation of UTUC preoperatively; therefore, chemotherapy could lead to overtreatment for some.

“We plan to go back and look at the CT urograms and the diagnostic imaging done prior to surgery just to see if we can be 100% confident in our diagnostic accuracy preoperatively, to see if we would be more confident with a neoadjuvant study,” she added. The investigators have also reviewed data from the British Association of Urological Surgeons on the postoperative dip in GFR. “It didn’t really seem from that 2015 data that there was a huge unmet need for patients postoperatively, where we would have missed them had we not treated them preoperatively,” she said.

On a related note, session attendee Surena Matin, MD, also of MD Anderson, asked “How many patients were potentially precluded because of their GFR, and do you have any data regarding response rates in the carboplatin arm?”

The main reason for exclusion was ineligible pathology and not GFR, according to Dr. Birtle. “This goes back to the previous question of can you be certain that a patient has locally advanced disease prior to nephro-ureterectomy? About 60% of patients who were thought to have muscle-invasive disease ultimately on nephro-ureterectomy didn’t.”

Confidence intervals for chemotherapy benefit in the subgroup given carboplatin were wide and overlapped unity, but still favoring benefit and falling within the overall treatment effect, she said.

Session attendee Joaquim Bellmunt, MD, Dana-Farber Cancer Institute, Boston, noted that the chemotherapy benefit was not significant in that subgroup and also in the subgroups with lymph node–positive disease and with positive margins. “I think that saying … chemotherapy is for everybody based on this trial” is incorrect, he asserted. “It may be good just to tone down the message that this is the new standard of care.” He further questioned the trial’s early stopping, noting that continuing would have provided more information in these patients.

Those subgroups were small, so analyses were underpowered to definitively rule out chemotherapy benefit, according to Dr. Birtle. The investigators had intensive discussion about the recommendation to stop early, because of a goal to determine overall survival impact. Ultimately, “when we saw the data in terms of disease-free survival and metastasis-free survival, the magnitude of the effect was so big that we felt it was uncomfortable and unethical not to offer patients treatment,” she said.

Study details

Patients in POUT’s chemotherapy arm received four cycles of chemotherapy—gemcitabine-cisplatin if their GFR was 50 mL/min or higher, or gemcitabine-carboplatin if their GFR was 30-49 mL/min—starting within 90 days of nephro-ureterectomy.

Of note, approximately 40% of all patients in the trial were aged 70 years or older, including the 5% who were aged 80 years or older. “This is very reassuring for a study of adjuvant platinum-based chemotherapy,” Dr. Birtle commented. Fully 71.2% of the chemotherapy patients received all four planned cycles.

In an intention-to-treat analysis, risk of disease-free survival events (death from any cause, metastasis, or any ureteric or renal bed recurrence) was sharply reduced with chemotherapy versus surveillance (hazard ratio, 0.49; P=.001). The proportion of patients event free at 2 years was 71% in the chemotherapy group and 54% in the surveillance group. Benefit was generally similar across subgroups, and findings were much the same after adjustment for nodal involvement, microscopic margin status, and planned chemotherapy regimen (hazard ratio, 0.47; P=.001).

Risk of metastasis-free survival events was also sharply lower with chemotherapy (hazard ratio, 0.49; P=.002), with a proportion event free at 2 years of 74% in the chemotherapy group and 60% in the surveillance group. These findings were also much the same after adjustment for the above factors (hazard ratio, 0.47; P=.002).

Overall survival tended to be better with chemotherapy than with surveillance (hazard ratio, 0.55), but data are still immature for this endpoint.

The rate of grade 3 or worse adverse events during the treatment period was 53.2% with chemotherapy and 13.5% with surveillance; events with chemotherapy were as expected, with neutropenia, thrombocytopenia, and gastrointestinal events predominating. The rate of febrile neutropenia was 5.7% with gemcitabine-cisplatin and 7.8% with gemcitabine-carboplatin, but there were no neutropenic deaths.

The rate of grade 3 or worse adverse events for the entire trial period was 62.1% with chemotherapy and 24.8% with surveillance.

Data on nephrotoxicity are still being evaluated, according to Dr. Birtle. Only seven patients who started on gemcitabine-cisplatin had to switch to gemcitabine-carboplatin because their GFR fell.

In a related translational study, the investigators are evaluating both the baseline CT urograms and the resected tumors to identify prognostic and predictive markers, she said.

Dr. Birtle disclosed that she receives honoraria from Roche, Janssen, Astellas, and Bayer, and is a consultant to Sanofi-Aventis. The trial was funded by the UK Clinical Trials Awards and Advisory Committee.

SOURCE: Birtle A et al. Genitourinary Cancers Symposium. Abstract 407

ESTES PARK, CO. – When patients with interstitial cystitis (IC) learn that first-line therapy is a rigorous diet designed to eliminate common bladder irritants, they tend to react in one of two ways, according to Julie A. Chacko, MD, a urologist in private practice in Santa Barbara, Calif.

Some “are just so grateful that they’re not crazy, which is what they’ve been told after 15 negative urine cultures. (Others) “look at the diet and think I’m sentencing them to death,” she said.

The sole medication approved by the Food and Drug Administration for IC is pentosan polysulfate sodium (Elmiron), and it should be reserved for the minority of patients who don’t experience significant improvement after giving the diet a reasonable shot, Dr. Chako advised. “When Elmiron works it’s great, but it’s not usually my go-to agent because it’s very expensive, you have to take it for 3-6 months to know for sure if it’s efficacious, and it has to be taken on an empty stomach. It’s a difficult medication.”

A poorly understood yet common disorder, IC has a prevalence estimated at 0.5%-4% in women, less in men. Although typically diagnosed in the fourth decade or later, IC occurs at all ages. In some studies, the delay from first appearance of symptoms to arrival at a diagnosis is up to 8 years.

Interstitial cystitis is increasingly being called bladder pain syndrome in the literature, said Dr. Chako, who added, “I personally don’t love bladder pain syndrome as a description for this process. This syndrome has variable symptoms, and patients can have no pain at all.”

The mechanisms that result in IC are a mystery. The leading theory is that a bladder permeability problem allows urinary irritants to reach the interstitium. Nearly 80% of patients with IC can, with coaxing, identify dietary triggers for their symptoms, thereby basically establishing the diagnosis.

Other proposed mechanisms include an infectious agent that’s yet to be identified, allergic reaction, and neuromodulatory dysfunction. Common triggers other than foods include menses, copulation, emotional distress, and bladder trauma, including transvaginal ultrasound.

Conditions commonly associated with IC include fibromyalgia, irritable bowel syndrome, chronic fatigue, vulvodynia, migraines, depression, and anxiety.

The most common symptoms of IC are urinary urgency and frequency. Many affected patients have dysuria. Some have pain, which is typically suprapubic. However, pain can be present anywhere in a band circumscribing the whole central section of the torso, including the lower back, lower abdomen, urethra, vagina, and vulva. Patients describe a range of pain – burning, aching, stabbing, itching, buzzing, or a feeling of pressure.

“Most women who come in with IC are married to the idea that they’re having recurrent UTIs. They’re going to get antibiotics any way they can for their UTIs: over the phone, at urgent care. You need to get them to buy into the idea that even though UTIs are common, maybe not all of their flares are infections. They ask, ‘Then why do I feel better when I’m on antibiotics for recurrent UTI even though the cultures are negative?’ I say, ‘You feel less stress and anxiety because you think you’re on effective treatment,” Dr. Chacko said.

The diagnosis of IC is one of exclusions. Diagnoses to rule out before arriving at IC include recurrent UTI; overactive bladder, which should present with pure urge frequency and respond to medications for that condition; kidney stone disease present at the end of the ureter where it enters the bladder; gastrointestinal pathology; bladder cancer; and ovarian or uterine pathology.

Referral to a urologist for cystoscopy and cytology is appropriate in patients with microscopic hematuria, a significant smoking history predisposing to bladder cancer, or severe pain with severe frequency, which raises the possibility of Hunner’s ulcers, considered pathognomic for IC, respond “beautifully” to fulguration, she said.

Otherwise, IC can readily be managed by interested primary care physicians. The IC diet initially calls for 2 weeks of strict avoidance of all high-risk foods, most of which are acidic foods. These include fruits and fruit juices, especially citrus and cranberry juices; tomatoes and tomato products, including ketchup; yogurt; chocolate; coffee and tea, including decaf; vinegar; spicy foods; and carbonated beverages, water included.

These foods can later be added back one at a time to the diet while watching for IC flares, which typically occur within hours to several days of re-introducing the food. The return to coffee consumption, if that’s something important to the patient, should be with low-acid coffee. If that triggers an IC flare, try decaf. In time, many patients find they can consume some trigger foods in modest amounts.

“I tell patients it will take 12-18 months to get a good handle on their IC,” Dr. Chacko noted.

The use of OTC alkalizing agents such as Prelief may diffuse dietary triggers. A teaspoon of baking soda in water is also effective.

Second-line treatments include oral hydroxyzine 10-20 mg at bedtime; amitriptyline 10-20 mg at bedtime, mainly for patients with predominant pain symptoms; cimeditine; and pentosan polysulfate at 100 mg TID.

For IC patients with pelvic muscle tightness on pelvic examination, referral to a physical therapist adept at pelvic floor trigger point release can work wonders, she added.

One second-line option is bladder instillations of dimethyl sulfoxide weekly for 6 weeks, cutting back to once monthly maintenance therapy if the more intensive regimen is effective. Instillation of “heparin with lidocaine is a rescue solution. If it’s going to work, it kicks in within a few hours and usually lasts for 24-72 hours. It gets patients through a weekend, a wedding, or a funeral. A response can help make the IC diagnosis, too,” Dr. Chacko said.

She reported having no financial conflicts of interest regarding her presentation.
 

[email protected]


 

ESTES PARK, CO. – When patients with interstitial cystitis (IC) learn that first-line therapy is a rigorous diet designed to eliminate common bladder irritants, they tend to react in one of two ways, according to Julie A. Chacko, MD, a urologist in private practice in Santa Barbara, Calif.

Some “are just so grateful that they’re not crazy, which is what they’ve been told after 15 negative urine cultures. (Others) “look at the diet and think I’m sentencing them to death,” she said.

The sole medication approved by the Food and Drug Administration for IC is pentosan polysulfate sodium (Elmiron), and it should be reserved for the minority of patients who don’t experience significant improvement after giving the diet a reasonable shot, Dr. Chako advised. “When Elmiron works it’s great, but it’s not usually my go-to agent because it’s very expensive, you have to take it for 3-6 months to know for sure if it’s efficacious, and it has to be taken on an empty stomach. It’s a difficult medication.”

A poorly understood yet common disorder, IC has a prevalence estimated at 0.5%-4% in women, less in men. Although typically diagnosed in the fourth decade or later, IC occurs at all ages. In some studies, the delay from first appearance of symptoms to arrival at a diagnosis is up to 8 years.

Interstitial cystitis is increasingly being called bladder pain syndrome in the literature, said Dr. Chako, who added, “I personally don’t love bladder pain syndrome as a description for this process. This syndrome has variable symptoms, and patients can have no pain at all.”

The mechanisms that result in IC are a mystery. The leading theory is that a bladder permeability problem allows urinary irritants to reach the interstitium. Nearly 80% of patients with IC can, with coaxing, identify dietary triggers for their symptoms, thereby basically establishing the diagnosis.

Other proposed mechanisms include an infectious agent that’s yet to be identified, allergic reaction, and neuromodulatory dysfunction. Common triggers other than foods include menses, copulation, emotional distress, and bladder trauma, including transvaginal ultrasound.

Conditions commonly associated with IC include fibromyalgia, irritable bowel syndrome, chronic fatigue, vulvodynia, migraines, depression, and anxiety.

The most common symptoms of IC are urinary urgency and frequency. Many affected patients have dysuria. Some have pain, which is typically suprapubic. However, pain can be present anywhere in a band circumscribing the whole central section of the torso, including the lower back, lower abdomen, urethra, vagina, and vulva. Patients describe a range of pain – burning, aching, stabbing, itching, buzzing, or a feeling of pressure.

“Most women who come in with IC are married to the idea that they’re having recurrent UTIs. They’re going to get antibiotics any way they can for their UTIs: over the phone, at urgent care. You need to get them to buy into the idea that even though UTIs are common, maybe not all of their flares are infections. They ask, ‘Then why do I feel better when I’m on antibiotics for recurrent UTI even though the cultures are negative?’ I say, ‘You feel less stress and anxiety because you think you’re on effective treatment,” Dr. Chacko said.

The diagnosis of IC is one of exclusions. Diagnoses to rule out before arriving at IC include recurrent UTI; overactive bladder, which should present with pure urge frequency and respond to medications for that condition; kidney stone disease present at the end of the ureter where it enters the bladder; gastrointestinal pathology; bladder cancer; and ovarian or uterine pathology.

Referral to a urologist for cystoscopy and cytology is appropriate in patients with microscopic hematuria, a significant smoking history predisposing to bladder cancer, or severe pain with severe frequency, which raises the possibility of Hunner’s ulcers, considered pathognomic for IC, respond “beautifully” to fulguration, she said.

Otherwise, IC can readily be managed by interested primary care physicians. The IC diet initially calls for 2 weeks of strict avoidance of all high-risk foods, most of which are acidic foods. These include fruits and fruit juices, especially citrus and cranberry juices; tomatoes and tomato products, including ketchup; yogurt; chocolate; coffee and tea, including decaf; vinegar; spicy foods; and carbonated beverages, water included.

These foods can later be added back one at a time to the diet while watching for IC flares, which typically occur within hours to several days of re-introducing the food. The return to coffee consumption, if that’s something important to the patient, should be with low-acid coffee. If that triggers an IC flare, try decaf. In time, many patients find they can consume some trigger foods in modest amounts.

“I tell patients it will take 12-18 months to get a good handle on their IC,” Dr. Chacko noted.

The use of OTC alkalizing agents such as Prelief may diffuse dietary triggers. A teaspoon of baking soda in water is also effective.

Second-line treatments include oral hydroxyzine 10-20 mg at bedtime; amitriptyline 10-20 mg at bedtime, mainly for patients with predominant pain symptoms; cimeditine; and pentosan polysulfate at 100 mg TID.

For IC patients with pelvic muscle tightness on pelvic examination, referral to a physical therapist adept at pelvic floor trigger point release can work wonders, she added.

One second-line option is bladder instillations of dimethyl sulfoxide weekly for 6 weeks, cutting back to once monthly maintenance therapy if the more intensive regimen is effective. Instillation of “heparin with lidocaine is a rescue solution. If it’s going to work, it kicks in within a few hours and usually lasts for 24-72 hours. It gets patients through a weekend, a wedding, or a funeral. A response can help make the IC diagnosis, too,” Dr. Chacko said.

She reported having no financial conflicts of interest regarding her presentation.
 

[email protected]


 

ESTES PARK, CO. – When patients with interstitial cystitis (IC) learn that first-line therapy is a rigorous diet designed to eliminate common bladder irritants, they tend to react in one of two ways, according to Julie A. Chacko, MD, a urologist in private practice in Santa Barbara, Calif.

Some “are just so grateful that they’re not crazy, which is what they’ve been told after 15 negative urine cultures. (Others) “look at the diet and think I’m sentencing them to death,” she said.

The sole medication approved by the Food and Drug Administration for IC is pentosan polysulfate sodium (Elmiron), and it should be reserved for the minority of patients who don’t experience significant improvement after giving the diet a reasonable shot, Dr. Chako advised. “When Elmiron works it’s great, but it’s not usually my go-to agent because it’s very expensive, you have to take it for 3-6 months to know for sure if it’s efficacious, and it has to be taken on an empty stomach. It’s a difficult medication.”

A poorly understood yet common disorder, IC has a prevalence estimated at 0.5%-4% in women, less in men. Although typically diagnosed in the fourth decade or later, IC occurs at all ages. In some studies, the delay from first appearance of symptoms to arrival at a diagnosis is up to 8 years.

Interstitial cystitis is increasingly being called bladder pain syndrome in the literature, said Dr. Chako, who added, “I personally don’t love bladder pain syndrome as a description for this process. This syndrome has variable symptoms, and patients can have no pain at all.”

The mechanisms that result in IC are a mystery. The leading theory is that a bladder permeability problem allows urinary irritants to reach the interstitium. Nearly 80% of patients with IC can, with coaxing, identify dietary triggers for their symptoms, thereby basically establishing the diagnosis.

Other proposed mechanisms include an infectious agent that’s yet to be identified, allergic reaction, and neuromodulatory dysfunction. Common triggers other than foods include menses, copulation, emotional distress, and bladder trauma, including transvaginal ultrasound.

Conditions commonly associated with IC include fibromyalgia, irritable bowel syndrome, chronic fatigue, vulvodynia, migraines, depression, and anxiety.

The most common symptoms of IC are urinary urgency and frequency. Many affected patients have dysuria. Some have pain, which is typically suprapubic. However, pain can be present anywhere in a band circumscribing the whole central section of the torso, including the lower back, lower abdomen, urethra, vagina, and vulva. Patients describe a range of pain – burning, aching, stabbing, itching, buzzing, or a feeling of pressure.

“Most women who come in with IC are married to the idea that they’re having recurrent UTIs. They’re going to get antibiotics any way they can for their UTIs: over the phone, at urgent care. You need to get them to buy into the idea that even though UTIs are common, maybe not all of their flares are infections. They ask, ‘Then why do I feel better when I’m on antibiotics for recurrent UTI even though the cultures are negative?’ I say, ‘You feel less stress and anxiety because you think you’re on effective treatment,” Dr. Chacko said.

The diagnosis of IC is one of exclusions. Diagnoses to rule out before arriving at IC include recurrent UTI; overactive bladder, which should present with pure urge frequency and respond to medications for that condition; kidney stone disease present at the end of the ureter where it enters the bladder; gastrointestinal pathology; bladder cancer; and ovarian or uterine pathology.

Referral to a urologist for cystoscopy and cytology is appropriate in patients with microscopic hematuria, a significant smoking history predisposing to bladder cancer, or severe pain with severe frequency, which raises the possibility of Hunner’s ulcers, considered pathognomic for IC, respond “beautifully” to fulguration, she said.

Otherwise, IC can readily be managed by interested primary care physicians. The IC diet initially calls for 2 weeks of strict avoidance of all high-risk foods, most of which are acidic foods. These include fruits and fruit juices, especially citrus and cranberry juices; tomatoes and tomato products, including ketchup; yogurt; chocolate; coffee and tea, including decaf; vinegar; spicy foods; and carbonated beverages, water included.

These foods can later be added back one at a time to the diet while watching for IC flares, which typically occur within hours to several days of re-introducing the food. The return to coffee consumption, if that’s something important to the patient, should be with low-acid coffee. If that triggers an IC flare, try decaf. In time, many patients find they can consume some trigger foods in modest amounts.

“I tell patients it will take 12-18 months to get a good handle on their IC,” Dr. Chacko noted.

The use of OTC alkalizing agents such as Prelief may diffuse dietary triggers. A teaspoon of baking soda in water is also effective.

Second-line treatments include oral hydroxyzine 10-20 mg at bedtime; amitriptyline 10-20 mg at bedtime, mainly for patients with predominant pain symptoms; cimeditine; and pentosan polysulfate at 100 mg TID.

For IC patients with pelvic muscle tightness on pelvic examination, referral to a physical therapist adept at pelvic floor trigger point release can work wonders, she added.

One second-line option is bladder instillations of dimethyl sulfoxide weekly for 6 weeks, cutting back to once monthly maintenance therapy if the more intensive regimen is effective. Instillation of “heparin with lidocaine is a rescue solution. If it’s going to work, it kicks in within a few hours and usually lasts for 24-72 hours. It gets patients through a weekend, a wedding, or a funeral. A response can help make the IC diagnosis, too,” Dr. Chacko said.

She reported having no financial conflicts of interest regarding her presentation.
 

[email protected]


 

NEW YORK – Prior to October 2014, urology patients undergoing radical cystectomy at a 950-bed, tertiary care hospital experienced postoperative morbidity at a relative high rate, according to NSQIP data.

“Despite improvements in surgical techniques and perioperative care protocols, the rate of the overall morbidity for radical cystectomy was higher than we would like to see,” said Tracey Hong, RN, BScN, of the Clinical Quality and Patient Safety Department at Vancouver (B.C.) General Hospital. “We took this as an opportunity to improve our patient outcomes and experience.”

Vancouver General joined the American College of Surgeons National Surgical Improvement Quality Program (ACS NSQIP) in 2011. The enhanced recovery after surgery (ERAS) perioperative protocol the institution adopted in late 2014 was associated with a 32% decrease in overall morbidity. The rate dropped from 31.3% in the pre-ERAS study period from May 2011 to September 2014, to 21.1% after implementation, from October 2014 to September 2016, according to a study Ms. Hong presented at the American College of Surgeons Quality and Safety Conference.

The investigators compared outcomes between all 92 people undergoing elective radical cystectomy during the first time period to 152 consecutive patients treated under the ERAS protocol. Median length of stay decreased from 8 days before ERAS to 7 days after, a significant difference (P less than .05).

The researchers also assessed outcomes based on how adherent clinicians were to 12 key elements of the 26-item ERAS initiative. These elements included preoperative counseling, preoperative anesthesia consultation, and carbohydrate loading on the morning of surgery. Intraoperatively, they tracked normothermia, use of multimodal anesthesia, use of goal-directed fluid therapy using a monitor, timely antibiotics, and adequate postoperative nausea and vomiting prophylaxis. The four postoperative key measures were mobilization at least once by postoperative day 0, full fluids and mobilization twice on postoperative day 1, and starting solid food by postoperative day 4.

A total 52% of the ERAS cases were associated with 75% or greater adherence to these 12 key items. Adherence with the intraoperative fluid therapy and all the postoperative elements proved to be the most challenging, Ms. Hong said.

The more adherent cases experienced a lower overall postoperative morbidity rate, 15.2%, compared with 27.4% among the less adherent group. The 15.2% morbidity among the more adherent cases also compared favorably with the 31.1% rate for cases prior to ERAS adoption.

“We will continue working on improving compliance,” Ms. Hong said. “We need to increase adherence to goal-directed fluid therapy and the postoperative components,” Ms. Hong said.

Three main strategies remain essential to the ongoing success of the ERAS program, Ms. Hong said. Empowering patients to be active participants and to engage in their own health outcomes is one. “Second, we involve a multidisciplinary team at an early stage so they take ownership and get engaged in the program,” she said. “Last but not least, we continue to measure the outcomes in 100% of cases.”

Continuous auditing and sharing results with the team on a regular basis will be necessary to maintain engagement in the ERAS protocol going forward, Ms. Hong added. “Tenacity is vital.”

Ms. Hong had no relevant financial disclosures.

[email protected]

NEW YORK – Prior to October 2014, urology patients undergoing radical cystectomy at a 950-bed, tertiary care hospital experienced postoperative morbidity at a relative high rate, according to NSQIP data.

“Despite improvements in surgical techniques and perioperative care protocols, the rate of the overall morbidity for radical cystectomy was higher than we would like to see,” said Tracey Hong, RN, BScN, of the Clinical Quality and Patient Safety Department at Vancouver (B.C.) General Hospital. “We took this as an opportunity to improve our patient outcomes and experience.”

Vancouver General joined the American College of Surgeons National Surgical Improvement Quality Program (ACS NSQIP) in 2011. The enhanced recovery after surgery (ERAS) perioperative protocol the institution adopted in late 2014 was associated with a 32% decrease in overall morbidity. The rate dropped from 31.3% in the pre-ERAS study period from May 2011 to September 2014, to 21.1% after implementation, from October 2014 to September 2016, according to a study Ms. Hong presented at the American College of Surgeons Quality and Safety Conference.

The investigators compared outcomes between all 92 people undergoing elective radical cystectomy during the first time period to 152 consecutive patients treated under the ERAS protocol. Median length of stay decreased from 8 days before ERAS to 7 days after, a significant difference (P less than .05).

The researchers also assessed outcomes based on how adherent clinicians were to 12 key elements of the 26-item ERAS initiative. These elements included preoperative counseling, preoperative anesthesia consultation, and carbohydrate loading on the morning of surgery. Intraoperatively, they tracked normothermia, use of multimodal anesthesia, use of goal-directed fluid therapy using a monitor, timely antibiotics, and adequate postoperative nausea and vomiting prophylaxis. The four postoperative key measures were mobilization at least once by postoperative day 0, full fluids and mobilization twice on postoperative day 1, and starting solid food by postoperative day 4.

A total 52% of the ERAS cases were associated with 75% or greater adherence to these 12 key items. Adherence with the intraoperative fluid therapy and all the postoperative elements proved to be the most challenging, Ms. Hong said.

The more adherent cases experienced a lower overall postoperative morbidity rate, 15.2%, compared with 27.4% among the less adherent group. The 15.2% morbidity among the more adherent cases also compared favorably with the 31.1% rate for cases prior to ERAS adoption.

“We will continue working on improving compliance,” Ms. Hong said. “We need to increase adherence to goal-directed fluid therapy and the postoperative components,” Ms. Hong said.

Three main strategies remain essential to the ongoing success of the ERAS program, Ms. Hong said. Empowering patients to be active participants and to engage in their own health outcomes is one. “Second, we involve a multidisciplinary team at an early stage so they take ownership and get engaged in the program,” she said. “Last but not least, we continue to measure the outcomes in 100% of cases.”

Continuous auditing and sharing results with the team on a regular basis will be necessary to maintain engagement in the ERAS protocol going forward, Ms. Hong added. “Tenacity is vital.”

Ms. Hong had no relevant financial disclosures.

[email protected]

NEW YORK – Prior to October 2014, urology patients undergoing radical cystectomy at a 950-bed, tertiary care hospital experienced postoperative morbidity at a relative high rate, according to NSQIP data.

“Despite improvements in surgical techniques and perioperative care protocols, the rate of the overall morbidity for radical cystectomy was higher than we would like to see,” said Tracey Hong, RN, BScN, of the Clinical Quality and Patient Safety Department at Vancouver (B.C.) General Hospital. “We took this as an opportunity to improve our patient outcomes and experience.”

Vancouver General joined the American College of Surgeons National Surgical Improvement Quality Program (ACS NSQIP) in 2011. The enhanced recovery after surgery (ERAS) perioperative protocol the institution adopted in late 2014 was associated with a 32% decrease in overall morbidity. The rate dropped from 31.3% in the pre-ERAS study period from May 2011 to September 2014, to 21.1% after implementation, from October 2014 to September 2016, according to a study Ms. Hong presented at the American College of Surgeons Quality and Safety Conference.

The investigators compared outcomes between all 92 people undergoing elective radical cystectomy during the first time period to 152 consecutive patients treated under the ERAS protocol. Median length of stay decreased from 8 days before ERAS to 7 days after, a significant difference (P less than .05).

The researchers also assessed outcomes based on how adherent clinicians were to 12 key elements of the 26-item ERAS initiative. These elements included preoperative counseling, preoperative anesthesia consultation, and carbohydrate loading on the morning of surgery. Intraoperatively, they tracked normothermia, use of multimodal anesthesia, use of goal-directed fluid therapy using a monitor, timely antibiotics, and adequate postoperative nausea and vomiting prophylaxis. The four postoperative key measures were mobilization at least once by postoperative day 0, full fluids and mobilization twice on postoperative day 1, and starting solid food by postoperative day 4.

A total 52% of the ERAS cases were associated with 75% or greater adherence to these 12 key items. Adherence with the intraoperative fluid therapy and all the postoperative elements proved to be the most challenging, Ms. Hong said.

The more adherent cases experienced a lower overall postoperative morbidity rate, 15.2%, compared with 27.4% among the less adherent group. The 15.2% morbidity among the more adherent cases also compared favorably with the 31.1% rate for cases prior to ERAS adoption.

“We will continue working on improving compliance,” Ms. Hong said. “We need to increase adherence to goal-directed fluid therapy and the postoperative components,” Ms. Hong said.

Three main strategies remain essential to the ongoing success of the ERAS program, Ms. Hong said. Empowering patients to be active participants and to engage in their own health outcomes is one. “Second, we involve a multidisciplinary team at an early stage so they take ownership and get engaged in the program,” she said. “Last but not least, we continue to measure the outcomes in 100% of cases.”

Continuous auditing and sharing results with the team on a regular basis will be necessary to maintain engagement in the ERAS protocol going forward, Ms. Hong added. “Tenacity is vital.”

Ms. Hong had no relevant financial disclosures.

[email protected]

SAN DIEGO – Should a man with a distant history of pedophilia be allowed to get a penile prosthetic implant to treat his erectile dysfunction? Mental health professionals at a Veterans Affairs medical center in San Diego recently faced this question and decided the risk was too great. They denied his request.

“This kind of dilemma occurs throughout all health systems, and it’s very challenging. It obviously puts the physician in a very ethically challenging situation,” said Kristin Beizai, MD, a psychiatrist and coauthor of a case report presented at the annual meeting of the American Psychiatric Association.

Yash B. Joshi, MD, PhD, and Dr. Beizai, both psychiatrists at the University of California, San Diego, and the VA San Diego Healthcare System, reported the penile prosthetic implant case in a poster at APA.

According to them, a married veteran sought treatment for erectile dysfunction (ED) from VA hospital urologists after oral treatment had failed. The elderly man, who had been imprisoned for 3 years some 25-30 years previously, sought a penile prosthetic implant – an alternative to treatments for ED when drugs have failed. Other options include self-injections and vacuum devices.

Men with the implants trigger erections by squeezing a pump in the scrotum that allows fluid to flow from a reservoir into the cylinder.

The man had been imprisoned in his 40s for 3 years because of a single incident of sexually abusing a toddler. According to the case report, his primary care doctors previously had offered him ED treatments “without acknowledging this history in their clinical-decision making process.”

A psychologist determined the man to be at low risk of committing a sexual offense again and cleared him for an implant. But his urologists requested an ethics consultation, which was provided by a team that included representatives from the fields of psychiatry, internal medicine, nursing, and social work.

“The ethics team determined that the most appropriate course of action hinged on a thorough and individualized risk-benefit assessment to determine if providing the treatment was ethically justifiable,” Dr. Beizai said in an interview.

An on-site psychologist and an outside expert evaluated the patient using a tool known as the Violence Risk Assessment Instrument–Sexual and determined the man was at moderate to severe risk of committing a sexual offense again.

“It was also discovered that the patient never completed treatment for pedophilia in the community as previously recommended,” the psychiatrists reported. “He was offered a plan for reevaluation and rehabilitation by subspecialists but declined this option.”

The man subsequently died of natural causes.

Dr. Beizai said those kinds of cases present numerous challenges. “This case involves surgery/urology, but this is an issue with primary care as well, and they likely do not have the time, resources, or protocol to address fully, particularly when legal information may be withheld and there are confidentiality issues.”

In regard to a risk-benefit analysis, she said, “a general mental health practitioner may not be comfortable completing this kind of assessment, and there may be an indication to refer to a forensic psychiatrist or psychologist. But this can be an expensive and scarce resource.”

There’s also the potential for political storms if the news gets out that a convicted sex offender received ED treatment. News reports in the mid-2000s about this kind of care persuaded several states to ban government payments for ED treatment for convicted sex offenders, and Medicaid funding was eliminated.

Two researchers who study pedophilia said in an interview that these decisions are far from simple and must take several factors into account.

Fred S. Berlin, MD, PhD, director of the Sexual Behavior Consultation Unit, and associate professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, said a sexual offense background isn’t necessarily enough of a reason to deny ED treatment to a patient. Important factors for decision making, he said, include the nature of the previous offenses (such as whether they involved penile penetration, or the use of drugs or alcohol) and the state of an offender’s current relationship.

He added that it’s important to understand that the lack of functioning genitals isn’t a barrier to sexual abuse. “There shouldn’t be a narrow focus on the capacity of the penis to have an erection,” he said.

Treatment for ED in convicted sex offenders can be helpful in some cases, said Richard B. Krueger, MD, an associate clinical professor of psychiatry at Columbia University, New York, and medical director of the Sexual Behavior Clinic at New York State Psychiatric Institute. “The general sense is that it would be a benefit to enable an appropriate, peer-related relationship with a spouse, significant other, or adults,” Dr. Krueger said.

Red flags regarding ED treatment in sex offenders, he said, include high scores on predictive tests, a history of extreme sadism or sociopathy, and challenges regarding monitoring of the offender.

Dr. Beizai, Dr. Joshi, Dr. Krueger, and Dr. Berlin reported no relevant disclosures.

[polldaddy:9767052]

SAN DIEGO – Should a man with a distant history of pedophilia be allowed to get a penile prosthetic implant to treat his erectile dysfunction? Mental health professionals at a Veterans Affairs medical center in San Diego recently faced this question and decided the risk was too great. They denied his request.

“This kind of dilemma occurs throughout all health systems, and it’s very challenging. It obviously puts the physician in a very ethically challenging situation,” said Kristin Beizai, MD, a psychiatrist and coauthor of a case report presented at the annual meeting of the American Psychiatric Association.

Yash B. Joshi, MD, PhD, and Dr. Beizai, both psychiatrists at the University of California, San Diego, and the VA San Diego Healthcare System, reported the penile prosthetic implant case in a poster at APA.

According to them, a married veteran sought treatment for erectile dysfunction (ED) from VA hospital urologists after oral treatment had failed. The elderly man, who had been imprisoned for 3 years some 25-30 years previously, sought a penile prosthetic implant – an alternative to treatments for ED when drugs have failed. Other options include self-injections and vacuum devices.

Men with the implants trigger erections by squeezing a pump in the scrotum that allows fluid to flow from a reservoir into the cylinder.

The man had been imprisoned in his 40s for 3 years because of a single incident of sexually abusing a toddler. According to the case report, his primary care doctors previously had offered him ED treatments “without acknowledging this history in their clinical-decision making process.”

A psychologist determined the man to be at low risk of committing a sexual offense again and cleared him for an implant. But his urologists requested an ethics consultation, which was provided by a team that included representatives from the fields of psychiatry, internal medicine, nursing, and social work.

“The ethics team determined that the most appropriate course of action hinged on a thorough and individualized risk-benefit assessment to determine if providing the treatment was ethically justifiable,” Dr. Beizai said in an interview.

An on-site psychologist and an outside expert evaluated the patient using a tool known as the Violence Risk Assessment Instrument–Sexual and determined the man was at moderate to severe risk of committing a sexual offense again.

“It was also discovered that the patient never completed treatment for pedophilia in the community as previously recommended,” the psychiatrists reported. “He was offered a plan for reevaluation and rehabilitation by subspecialists but declined this option.”

The man subsequently died of natural causes.

Dr. Beizai said those kinds of cases present numerous challenges. “This case involves surgery/urology, but this is an issue with primary care as well, and they likely do not have the time, resources, or protocol to address fully, particularly when legal information may be withheld and there are confidentiality issues.”

In regard to a risk-benefit analysis, she said, “a general mental health practitioner may not be comfortable completing this kind of assessment, and there may be an indication to refer to a forensic psychiatrist or psychologist. But this can be an expensive and scarce resource.”

There’s also the potential for political storms if the news gets out that a convicted sex offender received ED treatment. News reports in the mid-2000s about this kind of care persuaded several states to ban government payments for ED treatment for convicted sex offenders, and Medicaid funding was eliminated.

Two researchers who study pedophilia said in an interview that these decisions are far from simple and must take several factors into account.

Fred S. Berlin, MD, PhD, director of the Sexual Behavior Consultation Unit, and associate professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, said a sexual offense background isn’t necessarily enough of a reason to deny ED treatment to a patient. Important factors for decision making, he said, include the nature of the previous offenses (such as whether they involved penile penetration, or the use of drugs or alcohol) and the state of an offender’s current relationship.

He added that it’s important to understand that the lack of functioning genitals isn’t a barrier to sexual abuse. “There shouldn’t be a narrow focus on the capacity of the penis to have an erection,” he said.

Treatment for ED in convicted sex offenders can be helpful in some cases, said Richard B. Krueger, MD, an associate clinical professor of psychiatry at Columbia University, New York, and medical director of the Sexual Behavior Clinic at New York State Psychiatric Institute. “The general sense is that it would be a benefit to enable an appropriate, peer-related relationship with a spouse, significant other, or adults,” Dr. Krueger said.

Red flags regarding ED treatment in sex offenders, he said, include high scores on predictive tests, a history of extreme sadism or sociopathy, and challenges regarding monitoring of the offender.

Dr. Beizai, Dr. Joshi, Dr. Krueger, and Dr. Berlin reported no relevant disclosures.

[polldaddy:9767052]

SAN DIEGO – Should a man with a distant history of pedophilia be allowed to get a penile prosthetic implant to treat his erectile dysfunction? Mental health professionals at a Veterans Affairs medical center in San Diego recently faced this question and decided the risk was too great. They denied his request.

“This kind of dilemma occurs throughout all health systems, and it’s very challenging. It obviously puts the physician in a very ethically challenging situation,” said Kristin Beizai, MD, a psychiatrist and coauthor of a case report presented at the annual meeting of the American Psychiatric Association.

Yash B. Joshi, MD, PhD, and Dr. Beizai, both psychiatrists at the University of California, San Diego, and the VA San Diego Healthcare System, reported the penile prosthetic implant case in a poster at APA.

According to them, a married veteran sought treatment for erectile dysfunction (ED) from VA hospital urologists after oral treatment had failed. The elderly man, who had been imprisoned for 3 years some 25-30 years previously, sought a penile prosthetic implant – an alternative to treatments for ED when drugs have failed. Other options include self-injections and vacuum devices.

Men with the implants trigger erections by squeezing a pump in the scrotum that allows fluid to flow from a reservoir into the cylinder.

The man had been imprisoned in his 40s for 3 years because of a single incident of sexually abusing a toddler. According to the case report, his primary care doctors previously had offered him ED treatments “without acknowledging this history in their clinical-decision making process.”

A psychologist determined the man to be at low risk of committing a sexual offense again and cleared him for an implant. But his urologists requested an ethics consultation, which was provided by a team that included representatives from the fields of psychiatry, internal medicine, nursing, and social work.

“The ethics team determined that the most appropriate course of action hinged on a thorough and individualized risk-benefit assessment to determine if providing the treatment was ethically justifiable,” Dr. Beizai said in an interview.

An on-site psychologist and an outside expert evaluated the patient using a tool known as the Violence Risk Assessment Instrument–Sexual and determined the man was at moderate to severe risk of committing a sexual offense again.

“It was also discovered that the patient never completed treatment for pedophilia in the community as previously recommended,” the psychiatrists reported. “He was offered a plan for reevaluation and rehabilitation by subspecialists but declined this option.”

The man subsequently died of natural causes.

Dr. Beizai said those kinds of cases present numerous challenges. “This case involves surgery/urology, but this is an issue with primary care as well, and they likely do not have the time, resources, or protocol to address fully, particularly when legal information may be withheld and there are confidentiality issues.”

In regard to a risk-benefit analysis, she said, “a general mental health practitioner may not be comfortable completing this kind of assessment, and there may be an indication to refer to a forensic psychiatrist or psychologist. But this can be an expensive and scarce resource.”

There’s also the potential for political storms if the news gets out that a convicted sex offender received ED treatment. News reports in the mid-2000s about this kind of care persuaded several states to ban government payments for ED treatment for convicted sex offenders, and Medicaid funding was eliminated.

Two researchers who study pedophilia said in an interview that these decisions are far from simple and must take several factors into account.

Fred S. Berlin, MD, PhD, director of the Sexual Behavior Consultation Unit, and associate professor of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, said a sexual offense background isn’t necessarily enough of a reason to deny ED treatment to a patient. Important factors for decision making, he said, include the nature of the previous offenses (such as whether they involved penile penetration, or the use of drugs or alcohol) and the state of an offender’s current relationship.

He added that it’s important to understand that the lack of functioning genitals isn’t a barrier to sexual abuse. “There shouldn’t be a narrow focus on the capacity of the penis to have an erection,” he said.

Treatment for ED in convicted sex offenders can be helpful in some cases, said Richard B. Krueger, MD, an associate clinical professor of psychiatry at Columbia University, New York, and medical director of the Sexual Behavior Clinic at New York State Psychiatric Institute. “The general sense is that it would be a benefit to enable an appropriate, peer-related relationship with a spouse, significant other, or adults,” Dr. Krueger said.

Red flags regarding ED treatment in sex offenders, he said, include high scores on predictive tests, a history of extreme sadism or sociopathy, and challenges regarding monitoring of the offender.

Dr. Beizai, Dr. Joshi, Dr. Krueger, and Dr. Berlin reported no relevant disclosures.

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