Urology

Compared with open radical cystectomy, robot-assisted laparoscopic radical cystectomy did not reduce the number or severity of complications among patients with bladder cancer enrolled in a single-center randomized clinical trial, according to a letter to the editor in the New England Journal of Medicine.

Retrospective studies have suggested that the robot-assisted laparoscopic approach reduces the complication rate and shortens the length of hospitalization in patients with bladder cancer, many of whom are older, are smokers, and have coexisting conditions. This trial was designed to compare that approach against open radical cystectomy, with both procedures using extracorporeal urinary diversion, in 118 patients who had stage Ta-3N0-3M0 bladder cancer, said Dr. Bernard H. Bochner and his associates at Memorial Sloan Kettering Cancer Center, New York.

Courtesy Wikimedia Commons/Nimur/Creative Commons

The primary outcome – the rate of complications of grade 2-5 within 90 days of surgery—was 62% (37 of 60 patients) with robot-assisted laparoscopic surgery, which was not significantly different from the 66% rate (38 of 58 patients) with open surgery. Similarly, the rates of high-grade complications were not significantly different (22% vs 21%), and the mean length of hospitalization was identical (8 days) in both groups. The amount of intraoperative blood loss was smaller with the robot-assisted surgery (mean difference, 159 cc), but the duration of surgery was shorter with open surgery (mean difference, 127 minutes).

"Because the trial was performed by experienced surgeons at a single, high-volume referral center, the results may not be generalizable to all clinical settings. Nonetheless, these results highlight the need for randomized trials to inform the benefits and risks of new surgical technologies before widespread implementation," Dr. Bochner and his associates said (N. Engl. J. Med. 2014;371:389-90).

This work was supported by the Sidney Kimmel Center for Prostate and Urologic Cancers at Memorial Sloan Kettering Cancer Center, Pin Down Bladder Cancer, and the Michael A. and Zena Wiener Research and Therapeutics Program in Bladder Cancer. Dr. Bochner and his associates reported no financial conflicts of interest.

Compared with open radical cystectomy, robot-assisted laparoscopic radical cystectomy did not reduce the number or severity of complications among patients with bladder cancer enrolled in a single-center randomized clinical trial, according to a letter to the editor in the New England Journal of Medicine.

Retrospective studies have suggested that the robot-assisted laparoscopic approach reduces the complication rate and shortens the length of hospitalization in patients with bladder cancer, many of whom are older, are smokers, and have coexisting conditions. This trial was designed to compare that approach against open radical cystectomy, with both procedures using extracorporeal urinary diversion, in 118 patients who had stage Ta-3N0-3M0 bladder cancer, said Dr. Bernard H. Bochner and his associates at Memorial Sloan Kettering Cancer Center, New York.

Courtesy Wikimedia Commons/Nimur/Creative Commons

The primary outcome – the rate of complications of grade 2-5 within 90 days of surgery—was 62% (37 of 60 patients) with robot-assisted laparoscopic surgery, which was not significantly different from the 66% rate (38 of 58 patients) with open surgery. Similarly, the rates of high-grade complications were not significantly different (22% vs 21%), and the mean length of hospitalization was identical (8 days) in both groups. The amount of intraoperative blood loss was smaller with the robot-assisted surgery (mean difference, 159 cc), but the duration of surgery was shorter with open surgery (mean difference, 127 minutes).

"Because the trial was performed by experienced surgeons at a single, high-volume referral center, the results may not be generalizable to all clinical settings. Nonetheless, these results highlight the need for randomized trials to inform the benefits and risks of new surgical technologies before widespread implementation," Dr. Bochner and his associates said (N. Engl. J. Med. 2014;371:389-90).

This work was supported by the Sidney Kimmel Center for Prostate and Urologic Cancers at Memorial Sloan Kettering Cancer Center, Pin Down Bladder Cancer, and the Michael A. and Zena Wiener Research and Therapeutics Program in Bladder Cancer. Dr. Bochner and his associates reported no financial conflicts of interest.

Compared with open radical cystectomy, robot-assisted laparoscopic radical cystectomy did not reduce the number or severity of complications among patients with bladder cancer enrolled in a single-center randomized clinical trial, according to a letter to the editor in the New England Journal of Medicine.

Retrospective studies have suggested that the robot-assisted laparoscopic approach reduces the complication rate and shortens the length of hospitalization in patients with bladder cancer, many of whom are older, are smokers, and have coexisting conditions. This trial was designed to compare that approach against open radical cystectomy, with both procedures using extracorporeal urinary diversion, in 118 patients who had stage Ta-3N0-3M0 bladder cancer, said Dr. Bernard H. Bochner and his associates at Memorial Sloan Kettering Cancer Center, New York.

Courtesy Wikimedia Commons/Nimur/Creative Commons

The primary outcome – the rate of complications of grade 2-5 within 90 days of surgery—was 62% (37 of 60 patients) with robot-assisted laparoscopic surgery, which was not significantly different from the 66% rate (38 of 58 patients) with open surgery. Similarly, the rates of high-grade complications were not significantly different (22% vs 21%), and the mean length of hospitalization was identical (8 days) in both groups. The amount of intraoperative blood loss was smaller with the robot-assisted surgery (mean difference, 159 cc), but the duration of surgery was shorter with open surgery (mean difference, 127 minutes).

"Because the trial was performed by experienced surgeons at a single, high-volume referral center, the results may not be generalizable to all clinical settings. Nonetheless, these results highlight the need for randomized trials to inform the benefits and risks of new surgical technologies before widespread implementation," Dr. Bochner and his associates said (N. Engl. J. Med. 2014;371:389-90).

This work was supported by the Sidney Kimmel Center for Prostate and Urologic Cancers at Memorial Sloan Kettering Cancer Center, Pin Down Bladder Cancer, and the Michael A. and Zena Wiener Research and Therapeutics Program in Bladder Cancer. Dr. Bochner and his associates reported no financial conflicts of interest.

WASHINGTON – Bowel preparation for vaginal reconstructive surgery does not affect postoperative bowel function and bowel symptoms one way or the other, according to a secondary analysis of a single-blind randomized trial examining various effects of mechanical bowel preparation.

In a primary analysis published earlier this year, investigators found no benefit to mechanical bowel preparation with regard to the operative field quality. They also found that patients who were randomized not to receive bowel preparation were more satisfied and had fewer abdominal symptoms than those who received the intervention – a clear-liquid diet and enemas (Obstet. Gynecol. 2014;123:232-8).

The new analysis, reported at the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association, looked more closely at postoperative bowel habits after vaginal reconstructive surgery.

"As surgical intervention for pelvic organ prolapse increases, so does our need for knowledge of [best] perioperative management practices," said Dr. Alicia C. Ballard of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama at Birmingham, where the study was conducted.

"Concerns about painful defecation and GI symptoms such as nausea and vomiting are significant concerns for women undergoing surgery," she said.

Women may be predisposed to postsurgical constipation as a result of preoperative bowel preparation (including diet), the lasting effects of anesthesia, the use of narcotics, and the surgery itself. Prior research has shown, moreover, that constipation and incomplete bowel evacuation are not uncommon preoperatively in women with pelvic organ prolapse, she noted.

The study randomized 150 women scheduled to undergo vaginal prolapse surgery with, at a minimum, a planned apical suspension and posterior compartment repair. Surgeries included other prolapse and incontinence procedures.

Women randomized to the bowel preparation group were instructed to have a clear-liquid diet and to self-administer two saline enemas in the late afternoon of the day before surgery.

Those who were randomized to receive no intervention were allowed to have a regular diet. Women in both groups were instructed to eat nothing after midnight on the day of surgery.

All study participants were instructed to complete a bowel diary for 7 days preoperatively and 14 days postoperatively. Those who completed the preoperative diary and 10 of 14 days of the postoperative diary were included in the analysis.

Of the 150 women randomized at the preoperative visit in a 1:1 fashion, 5 withdrew from the study or had surgery canceled, and 121 completed the bowel diary.

The mean time to first bowel movement after surgery was similar in the two groups: 3.3 days in the bowel prep group and 3.2 days in the control group. The groups were also similar with regard to pain, fecal urgency, and stool transit times on the day of the first postoperative bowel movement. The use of antiemetics postoperatively was similar as well (48% and 55% in the bowel prep and no-prep groups, respectively.)

Most of the 121 women – across both groups – used at least one laxative postoperatively, mainly osmotic laxatives. Women who had not received bowel preparation were more likely, however, to report daily fiber use.

"Bowel preparation ... doesn’t appear to affect the return of bowel function and other bowel symptoms postoperatively," Dr. Ballard said. Moreover, "the lack of bowel preparation doesn’t seem to impact painful defecation symptoms, and most women use some type of laxative."

The study’s exclusion criteria included colorectal cancer, inflammatory bowel disease, a history of bowel resection, neurological disorders, and symptoms of colonic inertia (fewer than three bowel movements per week). The decision to exclude patients with significant preoperative constipation was made in order to "decrease the risk of bowel dysfunction and was important for our primary outcomes," Dr. Ballard explained. "But there actually were not that many women excluded."

Dr. Ballard reported that she had no disclosures. Two of her five coinvestigators reported various relationships with St. Jude Medical and Pelvalon.

WASHINGTON – Bowel preparation for vaginal reconstructive surgery does not affect postoperative bowel function and bowel symptoms one way or the other, according to a secondary analysis of a single-blind randomized trial examining various effects of mechanical bowel preparation.

In a primary analysis published earlier this year, investigators found no benefit to mechanical bowel preparation with regard to the operative field quality. They also found that patients who were randomized not to receive bowel preparation were more satisfied and had fewer abdominal symptoms than those who received the intervention – a clear-liquid diet and enemas (Obstet. Gynecol. 2014;123:232-8).

The new analysis, reported at the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association, looked more closely at postoperative bowel habits after vaginal reconstructive surgery.

"As surgical intervention for pelvic organ prolapse increases, so does our need for knowledge of [best] perioperative management practices," said Dr. Alicia C. Ballard of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama at Birmingham, where the study was conducted.

"Concerns about painful defecation and GI symptoms such as nausea and vomiting are significant concerns for women undergoing surgery," she said.

Women may be predisposed to postsurgical constipation as a result of preoperative bowel preparation (including diet), the lasting effects of anesthesia, the use of narcotics, and the surgery itself. Prior research has shown, moreover, that constipation and incomplete bowel evacuation are not uncommon preoperatively in women with pelvic organ prolapse, she noted.

The study randomized 150 women scheduled to undergo vaginal prolapse surgery with, at a minimum, a planned apical suspension and posterior compartment repair. Surgeries included other prolapse and incontinence procedures.

Women randomized to the bowel preparation group were instructed to have a clear-liquid diet and to self-administer two saline enemas in the late afternoon of the day before surgery.

Those who were randomized to receive no intervention were allowed to have a regular diet. Women in both groups were instructed to eat nothing after midnight on the day of surgery.

All study participants were instructed to complete a bowel diary for 7 days preoperatively and 14 days postoperatively. Those who completed the preoperative diary and 10 of 14 days of the postoperative diary were included in the analysis.

Of the 150 women randomized at the preoperative visit in a 1:1 fashion, 5 withdrew from the study or had surgery canceled, and 121 completed the bowel diary.

The mean time to first bowel movement after surgery was similar in the two groups: 3.3 days in the bowel prep group and 3.2 days in the control group. The groups were also similar with regard to pain, fecal urgency, and stool transit times on the day of the first postoperative bowel movement. The use of antiemetics postoperatively was similar as well (48% and 55% in the bowel prep and no-prep groups, respectively.)

Most of the 121 women – across both groups – used at least one laxative postoperatively, mainly osmotic laxatives. Women who had not received bowel preparation were more likely, however, to report daily fiber use.

"Bowel preparation ... doesn’t appear to affect the return of bowel function and other bowel symptoms postoperatively," Dr. Ballard said. Moreover, "the lack of bowel preparation doesn’t seem to impact painful defecation symptoms, and most women use some type of laxative."

The study’s exclusion criteria included colorectal cancer, inflammatory bowel disease, a history of bowel resection, neurological disorders, and symptoms of colonic inertia (fewer than three bowel movements per week). The decision to exclude patients with significant preoperative constipation was made in order to "decrease the risk of bowel dysfunction and was important for our primary outcomes," Dr. Ballard explained. "But there actually were not that many women excluded."

Dr. Ballard reported that she had no disclosures. Two of her five coinvestigators reported various relationships with St. Jude Medical and Pelvalon.

WASHINGTON – Bowel preparation for vaginal reconstructive surgery does not affect postoperative bowel function and bowel symptoms one way or the other, according to a secondary analysis of a single-blind randomized trial examining various effects of mechanical bowel preparation.

In a primary analysis published earlier this year, investigators found no benefit to mechanical bowel preparation with regard to the operative field quality. They also found that patients who were randomized not to receive bowel preparation were more satisfied and had fewer abdominal symptoms than those who received the intervention – a clear-liquid diet and enemas (Obstet. Gynecol. 2014;123:232-8).

The new analysis, reported at the scientific meetings of the American Urogynecologic Society and the International Urogynecological Association, looked more closely at postoperative bowel habits after vaginal reconstructive surgery.

"As surgical intervention for pelvic organ prolapse increases, so does our need for knowledge of [best] perioperative management practices," said Dr. Alicia C. Ballard of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama at Birmingham, where the study was conducted.

"Concerns about painful defecation and GI symptoms such as nausea and vomiting are significant concerns for women undergoing surgery," she said.

Women may be predisposed to postsurgical constipation as a result of preoperative bowel preparation (including diet), the lasting effects of anesthesia, the use of narcotics, and the surgery itself. Prior research has shown, moreover, that constipation and incomplete bowel evacuation are not uncommon preoperatively in women with pelvic organ prolapse, she noted.

The study randomized 150 women scheduled to undergo vaginal prolapse surgery with, at a minimum, a planned apical suspension and posterior compartment repair. Surgeries included other prolapse and incontinence procedures.

Women randomized to the bowel preparation group were instructed to have a clear-liquid diet and to self-administer two saline enemas in the late afternoon of the day before surgery.

Those who were randomized to receive no intervention were allowed to have a regular diet. Women in both groups were instructed to eat nothing after midnight on the day of surgery.

All study participants were instructed to complete a bowel diary for 7 days preoperatively and 14 days postoperatively. Those who completed the preoperative diary and 10 of 14 days of the postoperative diary were included in the analysis.

Of the 150 women randomized at the preoperative visit in a 1:1 fashion, 5 withdrew from the study or had surgery canceled, and 121 completed the bowel diary.

The mean time to first bowel movement after surgery was similar in the two groups: 3.3 days in the bowel prep group and 3.2 days in the control group. The groups were also similar with regard to pain, fecal urgency, and stool transit times on the day of the first postoperative bowel movement. The use of antiemetics postoperatively was similar as well (48% and 55% in the bowel prep and no-prep groups, respectively.)

Most of the 121 women – across both groups – used at least one laxative postoperatively, mainly osmotic laxatives. Women who had not received bowel preparation were more likely, however, to report daily fiber use.

"Bowel preparation ... doesn’t appear to affect the return of bowel function and other bowel symptoms postoperatively," Dr. Ballard said. Moreover, "the lack of bowel preparation doesn’t seem to impact painful defecation symptoms, and most women use some type of laxative."

The study’s exclusion criteria included colorectal cancer, inflammatory bowel disease, a history of bowel resection, neurological disorders, and symptoms of colonic inertia (fewer than three bowel movements per week). The decision to exclude patients with significant preoperative constipation was made in order to "decrease the risk of bowel dysfunction and was important for our primary outcomes," Dr. Ballard explained. "But there actually were not that many women excluded."

Dr. Ballard reported that she had no disclosures. Two of her five coinvestigators reported various relationships with St. Jude Medical and Pelvalon.

WASHINGTON – Women are not seeking care for even moderate to severe urinary incontinence because they have a fear of treatment and lack knowledge of the etiology of the condition and available treatment options, according to a qualitative focus group study at Kaiser Permanente Orange County (Calif.).

Embarrassment is another barrier. So are physicians themselves, said Dr. Jennifer K. Lee, a urogynecologist at Kaiser in Anaheim, Calif., who reported the findings at the annual meeting of the American Urogynecologic Society.

"Providers were mentioned (in the focus groups) to be barriers," Dr. Lee said. "Patients were either dismissed, or they were given misinformation."

By 2050, an estimated 50 million Americans will have urinary incontinence. Previous research has shown, however, that less than 50% of women with moderate incontinence seek care.

The focus group study involved 19 women – 11 who had not sought care but were found after recruitment to have moderate to severe incontinence by the Sandvik severity index, and 8 who had previous treatment or had been evaluated for urinary incontinence.

A moderator led discussions among small groups of these women, all of whom were fluent in English and most of whom (90%) had a college education or higher. The participants were of varying ethnicities, including Caucasian, Hispanic, and Asian.

A fear of medical or surgical treatment, including medication side effects and recovery time for surgery, was one of the themes to emerge. Women also said they felt embarrassed and were therefore not likely to raise the issue, particularly with time constraints in their medical visits.

There was a prevailing idea that urinary incontinence is a normal part of aging or childbearing, or that it is hereditary, and that other health issues take priority. Physicians, moreover, did not ask about the issue, and in cases in which it was mentioned, physicians were dismissive or gave misinformation, the study showed.

Dr. Lee said the barriers are significant, and that "there’s a lot of work to be done" to facilitate communication and change practices.

Leaders at Kaiser Permanente Orange County, Anaheim, Calif., plan to give physicians question prompts to incorporate into routine and primary care visits, she noted during a press conference at the meeting. "We also want to work on educational tools for the public," she said.

"There are urinary incontinence questions [for] the Medicare wellness visit, but these are for women over 65," she said. "There certainly are plenty of women under 65 who have incontinence."

Food and Drug Administration warnings about complications associated with transvaginal placement of surgical mesh did not come up in the focus group discussions, but Dr. Lee said that in her practice she has seen this controversy feed patients’ fear of incontinence and its treatment.

Study participants were recruited through e-mail research announcements and flyers, as well as more actively through the offices of urogynecology providers.

Dr. Lee said she had no disclosures to report. Her coauthors and research colleagues at the University of California, Irvine, reported numerous disclosures ranging from speakers’ bureau participation and consulting fees at Hospira and Cadence Pharmaceuticals to consultant positions with Medtronic and Boston Scientific.

WASHINGTON – Women are not seeking care for even moderate to severe urinary incontinence because they have a fear of treatment and lack knowledge of the etiology of the condition and available treatment options, according to a qualitative focus group study at Kaiser Permanente Orange County (Calif.).

Embarrassment is another barrier. So are physicians themselves, said Dr. Jennifer K. Lee, a urogynecologist at Kaiser in Anaheim, Calif., who reported the findings at the annual meeting of the American Urogynecologic Society.

"Providers were mentioned (in the focus groups) to be barriers," Dr. Lee said. "Patients were either dismissed, or they were given misinformation."

By 2050, an estimated 50 million Americans will have urinary incontinence. Previous research has shown, however, that less than 50% of women with moderate incontinence seek care.

The focus group study involved 19 women – 11 who had not sought care but were found after recruitment to have moderate to severe incontinence by the Sandvik severity index, and 8 who had previous treatment or had been evaluated for urinary incontinence.

A moderator led discussions among small groups of these women, all of whom were fluent in English and most of whom (90%) had a college education or higher. The participants were of varying ethnicities, including Caucasian, Hispanic, and Asian.

A fear of medical or surgical treatment, including medication side effects and recovery time for surgery, was one of the themes to emerge. Women also said they felt embarrassed and were therefore not likely to raise the issue, particularly with time constraints in their medical visits.

There was a prevailing idea that urinary incontinence is a normal part of aging or childbearing, or that it is hereditary, and that other health issues take priority. Physicians, moreover, did not ask about the issue, and in cases in which it was mentioned, physicians were dismissive or gave misinformation, the study showed.

Dr. Lee said the barriers are significant, and that "there’s a lot of work to be done" to facilitate communication and change practices.

Leaders at Kaiser Permanente Orange County, Anaheim, Calif., plan to give physicians question prompts to incorporate into routine and primary care visits, she noted during a press conference at the meeting. "We also want to work on educational tools for the public," she said.

"There are urinary incontinence questions [for] the Medicare wellness visit, but these are for women over 65," she said. "There certainly are plenty of women under 65 who have incontinence."

Food and Drug Administration warnings about complications associated with transvaginal placement of surgical mesh did not come up in the focus group discussions, but Dr. Lee said that in her practice she has seen this controversy feed patients’ fear of incontinence and its treatment.

Study participants were recruited through e-mail research announcements and flyers, as well as more actively through the offices of urogynecology providers.

Dr. Lee said she had no disclosures to report. Her coauthors and research colleagues at the University of California, Irvine, reported numerous disclosures ranging from speakers’ bureau participation and consulting fees at Hospira and Cadence Pharmaceuticals to consultant positions with Medtronic and Boston Scientific.

WASHINGTON – Women are not seeking care for even moderate to severe urinary incontinence because they have a fear of treatment and lack knowledge of the etiology of the condition and available treatment options, according to a qualitative focus group study at Kaiser Permanente Orange County (Calif.).

Embarrassment is another barrier. So are physicians themselves, said Dr. Jennifer K. Lee, a urogynecologist at Kaiser in Anaheim, Calif., who reported the findings at the annual meeting of the American Urogynecologic Society.

"Providers were mentioned (in the focus groups) to be barriers," Dr. Lee said. "Patients were either dismissed, or they were given misinformation."

By 2050, an estimated 50 million Americans will have urinary incontinence. Previous research has shown, however, that less than 50% of women with moderate incontinence seek care.

The focus group study involved 19 women – 11 who had not sought care but were found after recruitment to have moderate to severe incontinence by the Sandvik severity index, and 8 who had previous treatment or had been evaluated for urinary incontinence.

A moderator led discussions among small groups of these women, all of whom were fluent in English and most of whom (90%) had a college education or higher. The participants were of varying ethnicities, including Caucasian, Hispanic, and Asian.

A fear of medical or surgical treatment, including medication side effects and recovery time for surgery, was one of the themes to emerge. Women also said they felt embarrassed and were therefore not likely to raise the issue, particularly with time constraints in their medical visits.

There was a prevailing idea that urinary incontinence is a normal part of aging or childbearing, or that it is hereditary, and that other health issues take priority. Physicians, moreover, did not ask about the issue, and in cases in which it was mentioned, physicians were dismissive or gave misinformation, the study showed.

Dr. Lee said the barriers are significant, and that "there’s a lot of work to be done" to facilitate communication and change practices.

Leaders at Kaiser Permanente Orange County, Anaheim, Calif., plan to give physicians question prompts to incorporate into routine and primary care visits, she noted during a press conference at the meeting. "We also want to work on educational tools for the public," she said.

"There are urinary incontinence questions [for] the Medicare wellness visit, but these are for women over 65," she said. "There certainly are plenty of women under 65 who have incontinence."

Food and Drug Administration warnings about complications associated with transvaginal placement of surgical mesh did not come up in the focus group discussions, but Dr. Lee said that in her practice she has seen this controversy feed patients’ fear of incontinence and its treatment.

Study participants were recruited through e-mail research announcements and flyers, as well as more actively through the offices of urogynecology providers.

Dr. Lee said she had no disclosures to report. Her coauthors and research colleagues at the University of California, Irvine, reported numerous disclosures ranging from speakers’ bureau participation and consulting fees at Hospira and Cadence Pharmaceuticals to consultant positions with Medtronic and Boston Scientific.

Low-risk prostate cancer in older men is still being overtreated, according to two separate studies that examined the issue from different perspectives, both of which were published online July 14 in JAMA Internal Medicine.

One group of researchers found that primary androgen deprivation therapy fails to improve either overall or disease-specific survival in this patient population, yet it still is widely used as the initial treatment for localized disease. And another group found that urologists and radiation oncologists are the driving force behind the overly aggressive approach to low-risk prostate cancer in older men.

Both groups of investigators called for efforts to limit these harmful trends.

In the first study, Grace L. Lu-Yao, Ph.D., and her associates analyzed information on 66,717 cases of prostate cancer in the Surveillance, Epidemiology, and End Results (SEER) and Medicaid databases diagnosed in 1992-2009. All the patients were aged 66 years and older, and all had T1/T2 disease. There were 5,275 deaths from prostate cancer and 39,801 deaths from all causes during nearly 20 years of follow-up.

Primary androgen deprivation therapy failed to improve either overall or disease-specific survival at 5 years or 15 years. Further study using instrumental variable analysis to control for an imbalance in risk factors between users and nonusers of androgen deprivation therapy confirmed these results, as did several sensitivity analyses, "suggesting that our conclusions are robust" (JAMA Intern. Med. 2014 July 14 [doi: 10.1001/jamainternmed.2014.3028]).

"For patients with less aggressive cancers, deferred androgen deprivation therapy is safe and reduces the risks of treatment-associated adverse effects, such as osteoporosis, weight gain, decreased libido, decreased muscle tone, diabetes mellitus, and metabolic syndrome," wrote Dr. Lu-Yao of Rutgers Cancer Institute of New Jersey, New Brunswick, and her associates.

"Physicians and patients often believe that treatment is necessary and beneficial. Our data suggest that this may not be the case, at least for primary androgen deprivation therapy," they said.

In the other study, investigators examined physician and patient factors that influence treatment decisions in low-risk prostate cancer. They also analyzed SEER data, this time involving 12,068 men aged 66 years and older (median age, 72 years) who were diagnosed as having low-risk prostate adenocarcinoma in 2006-2009. These men were diagnosed by 2,145 urologists; 68% of them also consulted a radiation oncologist, said Dr. Karen E. Hoffman of the University of Texas M.D. Anderson Cancer Center, Houston, and her associates.

Fully 80% of the low-risk patients diagnosed by a urologist immediately received treatment; only 20% instead underwent observation, as is recommended. The use of observation varied markedly across urologists, with some performing observation for less than 5% of their patients and others performing observation for nearly 65%. Forty urologists (10.2%) had rates of observation that were significantly different from the mean.

In analyses that estimated the relative contributions of numerous factors to treatment decisions, "the diagnosing urologist was the most influential measured factor, responsible for 16.1% of the variance in management choice; just 7.9% of the variance was attributable to patient characteristics," Dr. Hoffman and her associates reported (JAMA Intern. Med. 2014 July 14 [doi: 10.1001/jamainternmed.2014.3021]).

Similarly, of the 7,554 men who consulted 870 radiation oncologists, a remarkable 91.5% underwent immediate treatment (usually radiotherapy), while only 8.5% underwent observation, as is recommended. The use of observation also varied markedly across radiation oncologists, with some advising observation for only 2% of their patients and others advising it for 47%. Again, the variance in treatment decisions attributable to radiation oncologists was at least double that attributable to patient factors.

"In our cohort, 70.0% of men aged 76-80 years and 55.1% of men older than 80 years still received up-front treatment," a striking proportion because the average life expectancy for men 77 years and older in the United States is less than 10 years. "Older men, especially those with multiple medical conditions, are not thought to gain a survival benefit from treatment of low-risk prostate cancer," Dr. Hoffman and her colleagues noted.

Their findings are important because most primary care physicians who refer their patients to specialists for prostate biopsy or consultation probably "assume that patients will receive similar management recommendations regardless of which [specialist] they see." These results demonstrate the opposite: Patients with low-risk prostate cancer could receive widely divergent treatment advice, solely depending on the specialists’ preferences.

Dr. Lu-Yao’s study was supported by the National Cancer Institute and the Cancer Institute of New Jersey. She reported ties to Merck and Schering-Plough, and one of her associates reported receiving research funding from Myriad. Dr. Hoffman’s study was supported by the Cancer Prevention and Research Institute of Texas, the National Cancer Institute, the American Cancer Society, the Duncan Family Institute, the University of Texas M.D. Anderson Cancer Center, and the National Institutes of Health. She reported no potential financial conflicts of interest, and one of her associates reported receiving research support from Varian Medical Systems.

Low-risk prostate cancer in older men is still being overtreated, according to two separate studies that examined the issue from different perspectives, both of which were published online July 14 in JAMA Internal Medicine.

One group of researchers found that primary androgen deprivation therapy fails to improve either overall or disease-specific survival in this patient population, yet it still is widely used as the initial treatment for localized disease. And another group found that urologists and radiation oncologists are the driving force behind the overly aggressive approach to low-risk prostate cancer in older men.

Both groups of investigators called for efforts to limit these harmful trends.

In the first study, Grace L. Lu-Yao, Ph.D., and her associates analyzed information on 66,717 cases of prostate cancer in the Surveillance, Epidemiology, and End Results (SEER) and Medicaid databases diagnosed in 1992-2009. All the patients were aged 66 years and older, and all had T1/T2 disease. There were 5,275 deaths from prostate cancer and 39,801 deaths from all causes during nearly 20 years of follow-up.

Primary androgen deprivation therapy failed to improve either overall or disease-specific survival at 5 years or 15 years. Further study using instrumental variable analysis to control for an imbalance in risk factors between users and nonusers of androgen deprivation therapy confirmed these results, as did several sensitivity analyses, "suggesting that our conclusions are robust" (JAMA Intern. Med. 2014 July 14 [doi: 10.1001/jamainternmed.2014.3028]).

"For patients with less aggressive cancers, deferred androgen deprivation therapy is safe and reduces the risks of treatment-associated adverse effects, such as osteoporosis, weight gain, decreased libido, decreased muscle tone, diabetes mellitus, and metabolic syndrome," wrote Dr. Lu-Yao of Rutgers Cancer Institute of New Jersey, New Brunswick, and her associates.

"Physicians and patients often believe that treatment is necessary and beneficial. Our data suggest that this may not be the case, at least for primary androgen deprivation therapy," they said.

In the other study, investigators examined physician and patient factors that influence treatment decisions in low-risk prostate cancer. They also analyzed SEER data, this time involving 12,068 men aged 66 years and older (median age, 72 years) who were diagnosed as having low-risk prostate adenocarcinoma in 2006-2009. These men were diagnosed by 2,145 urologists; 68% of them also consulted a radiation oncologist, said Dr. Karen E. Hoffman of the University of Texas M.D. Anderson Cancer Center, Houston, and her associates.

Fully 80% of the low-risk patients diagnosed by a urologist immediately received treatment; only 20% instead underwent observation, as is recommended. The use of observation varied markedly across urologists, with some performing observation for less than 5% of their patients and others performing observation for nearly 65%. Forty urologists (10.2%) had rates of observation that were significantly different from the mean.

In analyses that estimated the relative contributions of numerous factors to treatment decisions, "the diagnosing urologist was the most influential measured factor, responsible for 16.1% of the variance in management choice; just 7.9% of the variance was attributable to patient characteristics," Dr. Hoffman and her associates reported (JAMA Intern. Med. 2014 July 14 [doi: 10.1001/jamainternmed.2014.3021]).

Similarly, of the 7,554 men who consulted 870 radiation oncologists, a remarkable 91.5% underwent immediate treatment (usually radiotherapy), while only 8.5% underwent observation, as is recommended. The use of observation also varied markedly across radiation oncologists, with some advising observation for only 2% of their patients and others advising it for 47%. Again, the variance in treatment decisions attributable to radiation oncologists was at least double that attributable to patient factors.

"In our cohort, 70.0% of men aged 76-80 years and 55.1% of men older than 80 years still received up-front treatment," a striking proportion because the average life expectancy for men 77 years and older in the United States is less than 10 years. "Older men, especially those with multiple medical conditions, are not thought to gain a survival benefit from treatment of low-risk prostate cancer," Dr. Hoffman and her colleagues noted.

Their findings are important because most primary care physicians who refer their patients to specialists for prostate biopsy or consultation probably "assume that patients will receive similar management recommendations regardless of which [specialist] they see." These results demonstrate the opposite: Patients with low-risk prostate cancer could receive widely divergent treatment advice, solely depending on the specialists’ preferences.

Dr. Lu-Yao’s study was supported by the National Cancer Institute and the Cancer Institute of New Jersey. She reported ties to Merck and Schering-Plough, and one of her associates reported receiving research funding from Myriad. Dr. Hoffman’s study was supported by the Cancer Prevention and Research Institute of Texas, the National Cancer Institute, the American Cancer Society, the Duncan Family Institute, the University of Texas M.D. Anderson Cancer Center, and the National Institutes of Health. She reported no potential financial conflicts of interest, and one of her associates reported receiving research support from Varian Medical Systems.

Low-risk prostate cancer in older men is still being overtreated, according to two separate studies that examined the issue from different perspectives, both of which were published online July 14 in JAMA Internal Medicine.

One group of researchers found that primary androgen deprivation therapy fails to improve either overall or disease-specific survival in this patient population, yet it still is widely used as the initial treatment for localized disease. And another group found that urologists and radiation oncologists are the driving force behind the overly aggressive approach to low-risk prostate cancer in older men.

Both groups of investigators called for efforts to limit these harmful trends.

In the first study, Grace L. Lu-Yao, Ph.D., and her associates analyzed information on 66,717 cases of prostate cancer in the Surveillance, Epidemiology, and End Results (SEER) and Medicaid databases diagnosed in 1992-2009. All the patients were aged 66 years and older, and all had T1/T2 disease. There were 5,275 deaths from prostate cancer and 39,801 deaths from all causes during nearly 20 years of follow-up.

Primary androgen deprivation therapy failed to improve either overall or disease-specific survival at 5 years or 15 years. Further study using instrumental variable analysis to control for an imbalance in risk factors between users and nonusers of androgen deprivation therapy confirmed these results, as did several sensitivity analyses, "suggesting that our conclusions are robust" (JAMA Intern. Med. 2014 July 14 [doi: 10.1001/jamainternmed.2014.3028]).

"For patients with less aggressive cancers, deferred androgen deprivation therapy is safe and reduces the risks of treatment-associated adverse effects, such as osteoporosis, weight gain, decreased libido, decreased muscle tone, diabetes mellitus, and metabolic syndrome," wrote Dr. Lu-Yao of Rutgers Cancer Institute of New Jersey, New Brunswick, and her associates.

"Physicians and patients often believe that treatment is necessary and beneficial. Our data suggest that this may not be the case, at least for primary androgen deprivation therapy," they said.

In the other study, investigators examined physician and patient factors that influence treatment decisions in low-risk prostate cancer. They also analyzed SEER data, this time involving 12,068 men aged 66 years and older (median age, 72 years) who were diagnosed as having low-risk prostate adenocarcinoma in 2006-2009. These men were diagnosed by 2,145 urologists; 68% of them also consulted a radiation oncologist, said Dr. Karen E. Hoffman of the University of Texas M.D. Anderson Cancer Center, Houston, and her associates.

Fully 80% of the low-risk patients diagnosed by a urologist immediately received treatment; only 20% instead underwent observation, as is recommended. The use of observation varied markedly across urologists, with some performing observation for less than 5% of their patients and others performing observation for nearly 65%. Forty urologists (10.2%) had rates of observation that were significantly different from the mean.

In analyses that estimated the relative contributions of numerous factors to treatment decisions, "the diagnosing urologist was the most influential measured factor, responsible for 16.1% of the variance in management choice; just 7.9% of the variance was attributable to patient characteristics," Dr. Hoffman and her associates reported (JAMA Intern. Med. 2014 July 14 [doi: 10.1001/jamainternmed.2014.3021]).

Similarly, of the 7,554 men who consulted 870 radiation oncologists, a remarkable 91.5% underwent immediate treatment (usually radiotherapy), while only 8.5% underwent observation, as is recommended. The use of observation also varied markedly across radiation oncologists, with some advising observation for only 2% of their patients and others advising it for 47%. Again, the variance in treatment decisions attributable to radiation oncologists was at least double that attributable to patient factors.

"In our cohort, 70.0% of men aged 76-80 years and 55.1% of men older than 80 years still received up-front treatment," a striking proportion because the average life expectancy for men 77 years and older in the United States is less than 10 years. "Older men, especially those with multiple medical conditions, are not thought to gain a survival benefit from treatment of low-risk prostate cancer," Dr. Hoffman and her colleagues noted.

Their findings are important because most primary care physicians who refer their patients to specialists for prostate biopsy or consultation probably "assume that patients will receive similar management recommendations regardless of which [specialist] they see." These results demonstrate the opposite: Patients with low-risk prostate cancer could receive widely divergent treatment advice, solely depending on the specialists’ preferences.

Dr. Lu-Yao’s study was supported by the National Cancer Institute and the Cancer Institute of New Jersey. She reported ties to Merck and Schering-Plough, and one of her associates reported receiving research funding from Myriad. Dr. Hoffman’s study was supported by the Cancer Prevention and Research Institute of Texas, the National Cancer Institute, the American Cancer Society, the Duncan Family Institute, the University of Texas M.D. Anderson Cancer Center, and the National Institutes of Health. She reported no potential financial conflicts of interest, and one of her associates reported receiving research support from Varian Medical Systems.

ORLANDO – Success rates at 5 years were similar in women treated with a transobturator midurethral sling and women treated with a retropubic midurethral sling, but the transobturator patients were more likely to report an easing of symptoms, according to an extension of the Trial of Mid-Urethral Slings.

Overall satisfaction was similar in the two groups, Dr. Leslie M. Rickey reported during a Best Abstract session at the annual meeting of the American Urological Association.

Of 597 subjects in the Trial of Midurethral Slings (TOMUS), 404 participated in the extension phase (E-TOMUS). There was no significant difference in success rates – which declined over time – between those in the transobturator group and those in the retropubic group (43% vs. 51%). However, treatment success for retropubic midurethral slings was nearly 8% higher and did not meet equivalency criteria at 1 or 5 years, said Dr. Rickey, a urologist at Yale University, New Haven, Conn., who presented on behalf of Dr. Kimberly S. Kenton and the Urinary Incontinence Treatment Network.

Stress incontinence symptoms continued to increase over time in both groups but did not differ between the groups at 5 years; urge symptoms also increased over time but were reported significantly more often in the retropubic midurethral sling group.

"Overall urgency symptoms and sexual dysfunction, although still improved from baseline, did worsen over time," Dr. Rickey said, noting that they worsened significantly more overall in the retropubic group.

However, the proportion of patients who were completely or mostly satisfied remained similar in the groups (although it decreased from 92% and 93% to 80% and 85% in the groups, respectively, over time). Those in the transobturator group were almost twice as likely to report improvement in their urinary condition as measured by the Patient Global Impression of Improvement scale (odds ratio, 1.94), Dr. Rickey said.

With respect to adverse events, 10% of women overall experienced an adverse event (mainly urinary tract infections or mesh exposure) or serious adverse event; the rate did not differ between the groups. There were six serious adverse events requiring intervention, including one case of mesh erosion in each group and four urinary tract infections in the retropubic midurethral sling group.

"Importantly, there were seven new mesh exposures in years 3-5 after surgery," Dr. Rickey said, noting that three occurred in the retropubic midurethral sling group and four occurred in the transobturator midurethral sling group.

Women included in the extension phase were TOMUS participants who did not undergo surgical retreatment for stress urinary incontinence after the initial procedure. Participants completed annual in-person visits, including pelvic examination, symptom, mesh, and quality of life questionnaires.

Treatment success was defined as no retreatment for stress urinary incontinence, and no self-reported stress urinary incontinence symptoms using the Medical, Epidemiological, and Social Aspects of Aging questionnaire, she said.

"In conclusion, the 5-year continence rates did decline after either retropubic midurethral sling or transobturator sling, and did not meet prespecified criteria for equivalency. Satisfaction does remain high in both groups. In general, urinary symptoms and quality of life were more improved at 5 years after the transobturator approach, and mesh erosion rates remain low at 1.7%," she said.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors reported having no disclosures.

ORLANDO – Success rates at 5 years were similar in women treated with a transobturator midurethral sling and women treated with a retropubic midurethral sling, but the transobturator patients were more likely to report an easing of symptoms, according to an extension of the Trial of Mid-Urethral Slings.

Overall satisfaction was similar in the two groups, Dr. Leslie M. Rickey reported during a Best Abstract session at the annual meeting of the American Urological Association.

Of 597 subjects in the Trial of Midurethral Slings (TOMUS), 404 participated in the extension phase (E-TOMUS). There was no significant difference in success rates – which declined over time – between those in the transobturator group and those in the retropubic group (43% vs. 51%). However, treatment success for retropubic midurethral slings was nearly 8% higher and did not meet equivalency criteria at 1 or 5 years, said Dr. Rickey, a urologist at Yale University, New Haven, Conn., who presented on behalf of Dr. Kimberly S. Kenton and the Urinary Incontinence Treatment Network.

Stress incontinence symptoms continued to increase over time in both groups but did not differ between the groups at 5 years; urge symptoms also increased over time but were reported significantly more often in the retropubic midurethral sling group.

"Overall urgency symptoms and sexual dysfunction, although still improved from baseline, did worsen over time," Dr. Rickey said, noting that they worsened significantly more overall in the retropubic group.

However, the proportion of patients who were completely or mostly satisfied remained similar in the groups (although it decreased from 92% and 93% to 80% and 85% in the groups, respectively, over time). Those in the transobturator group were almost twice as likely to report improvement in their urinary condition as measured by the Patient Global Impression of Improvement scale (odds ratio, 1.94), Dr. Rickey said.

With respect to adverse events, 10% of women overall experienced an adverse event (mainly urinary tract infections or mesh exposure) or serious adverse event; the rate did not differ between the groups. There were six serious adverse events requiring intervention, including one case of mesh erosion in each group and four urinary tract infections in the retropubic midurethral sling group.

"Importantly, there were seven new mesh exposures in years 3-5 after surgery," Dr. Rickey said, noting that three occurred in the retropubic midurethral sling group and four occurred in the transobturator midurethral sling group.

Women included in the extension phase were TOMUS participants who did not undergo surgical retreatment for stress urinary incontinence after the initial procedure. Participants completed annual in-person visits, including pelvic examination, symptom, mesh, and quality of life questionnaires.

Treatment success was defined as no retreatment for stress urinary incontinence, and no self-reported stress urinary incontinence symptoms using the Medical, Epidemiological, and Social Aspects of Aging questionnaire, she said.

"In conclusion, the 5-year continence rates did decline after either retropubic midurethral sling or transobturator sling, and did not meet prespecified criteria for equivalency. Satisfaction does remain high in both groups. In general, urinary symptoms and quality of life were more improved at 5 years after the transobturator approach, and mesh erosion rates remain low at 1.7%," she said.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors reported having no disclosures.

ORLANDO – Success rates at 5 years were similar in women treated with a transobturator midurethral sling and women treated with a retropubic midurethral sling, but the transobturator patients were more likely to report an easing of symptoms, according to an extension of the Trial of Mid-Urethral Slings.

Overall satisfaction was similar in the two groups, Dr. Leslie M. Rickey reported during a Best Abstract session at the annual meeting of the American Urological Association.

Of 597 subjects in the Trial of Midurethral Slings (TOMUS), 404 participated in the extension phase (E-TOMUS). There was no significant difference in success rates – which declined over time – between those in the transobturator group and those in the retropubic group (43% vs. 51%). However, treatment success for retropubic midurethral slings was nearly 8% higher and did not meet equivalency criteria at 1 or 5 years, said Dr. Rickey, a urologist at Yale University, New Haven, Conn., who presented on behalf of Dr. Kimberly S. Kenton and the Urinary Incontinence Treatment Network.

Stress incontinence symptoms continued to increase over time in both groups but did not differ between the groups at 5 years; urge symptoms also increased over time but were reported significantly more often in the retropubic midurethral sling group.

"Overall urgency symptoms and sexual dysfunction, although still improved from baseline, did worsen over time," Dr. Rickey said, noting that they worsened significantly more overall in the retropubic group.

However, the proportion of patients who were completely or mostly satisfied remained similar in the groups (although it decreased from 92% and 93% to 80% and 85% in the groups, respectively, over time). Those in the transobturator group were almost twice as likely to report improvement in their urinary condition as measured by the Patient Global Impression of Improvement scale (odds ratio, 1.94), Dr. Rickey said.

With respect to adverse events, 10% of women overall experienced an adverse event (mainly urinary tract infections or mesh exposure) or serious adverse event; the rate did not differ between the groups. There were six serious adverse events requiring intervention, including one case of mesh erosion in each group and four urinary tract infections in the retropubic midurethral sling group.

"Importantly, there were seven new mesh exposures in years 3-5 after surgery," Dr. Rickey said, noting that three occurred in the retropubic midurethral sling group and four occurred in the transobturator midurethral sling group.

Women included in the extension phase were TOMUS participants who did not undergo surgical retreatment for stress urinary incontinence after the initial procedure. Participants completed annual in-person visits, including pelvic examination, symptom, mesh, and quality of life questionnaires.

Treatment success was defined as no retreatment for stress urinary incontinence, and no self-reported stress urinary incontinence symptoms using the Medical, Epidemiological, and Social Aspects of Aging questionnaire, she said.

"In conclusion, the 5-year continence rates did decline after either retropubic midurethral sling or transobturator sling, and did not meet prespecified criteria for equivalency. Satisfaction does remain high in both groups. In general, urinary symptoms and quality of life were more improved at 5 years after the transobturator approach, and mesh erosion rates remain low at 1.7%," she said.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors reported having no disclosures.

ORLANDO – Absence of comorbidities, larger remnant kidney volume/body surface area ratio, and larger tumor diameter were significant predictors of mild renal insufficiency following radical nephrectomy, and smaller tumor diameter was a significant predictor of severe renal insufficiency in an analysis of 53 cases.

"This is the first report to identify the remnant kidney volume/body surface area (RKV/BSA) ratio as a promising predictor of post–radical nephrectomy renal functional decline," according to Dr. Takehiro Sejima, a urologist at Tottori University, Yonago, Japan, whose research was featured in an "Outstanding Posters" session at the annual meeting of the American Urological Association.

At a cutoff value of 115, the RKV/BSA ratio had 47.6% sensitivity and 79.2% specificity for predicting mild renal insufficiency using a receiver operating characteristic curve, Dr. Sejima said.

A total of 21 patients categorized as having mild renal insufficiency and 32 patients categorized as having severe renal insufficiency were included in the study. Those with severe renal insufficiency had a significantly greater extent of global glomerulosclerosis, compared with those with mild renal insufficiency. Also, cardiovascular disease events occurred in 11 patients with severe renal insufficiency during up to 122.5 months of follow-up; no cardiovascular disease events occurred in those with mild renal insufficiency, he said.

Estimated glomerular filtration rates were measured preoperatively, and at 6-12 months after radical nephrectomy in 175 patients. Those with a greater than 20% drop in estimated glomerular filtration rates were classified as having mild renal insufficiency, and those with a percentage decline above 40% were classified as having severe renal insufficiency.

"Our results provide physicians and patients with a useful predictor of renal functional outcomes preoperatively. The consideration of post–radical nephrectomy medical management for the prevention of cardiovascular disease, except in mild renal insufficiency patients, should be a future step toward improving the overall survival of post–radical nephrectomy patients," he concluded.

Dr. Sejima reported having no disclosures.

ORLANDO – Absence of comorbidities, larger remnant kidney volume/body surface area ratio, and larger tumor diameter were significant predictors of mild renal insufficiency following radical nephrectomy, and smaller tumor diameter was a significant predictor of severe renal insufficiency in an analysis of 53 cases.

"This is the first report to identify the remnant kidney volume/body surface area (RKV/BSA) ratio as a promising predictor of post–radical nephrectomy renal functional decline," according to Dr. Takehiro Sejima, a urologist at Tottori University, Yonago, Japan, whose research was featured in an "Outstanding Posters" session at the annual meeting of the American Urological Association.

At a cutoff value of 115, the RKV/BSA ratio had 47.6% sensitivity and 79.2% specificity for predicting mild renal insufficiency using a receiver operating characteristic curve, Dr. Sejima said.

A total of 21 patients categorized as having mild renal insufficiency and 32 patients categorized as having severe renal insufficiency were included in the study. Those with severe renal insufficiency had a significantly greater extent of global glomerulosclerosis, compared with those with mild renal insufficiency. Also, cardiovascular disease events occurred in 11 patients with severe renal insufficiency during up to 122.5 months of follow-up; no cardiovascular disease events occurred in those with mild renal insufficiency, he said.

Estimated glomerular filtration rates were measured preoperatively, and at 6-12 months after radical nephrectomy in 175 patients. Those with a greater than 20% drop in estimated glomerular filtration rates were classified as having mild renal insufficiency, and those with a percentage decline above 40% were classified as having severe renal insufficiency.

"Our results provide physicians and patients with a useful predictor of renal functional outcomes preoperatively. The consideration of post–radical nephrectomy medical management for the prevention of cardiovascular disease, except in mild renal insufficiency patients, should be a future step toward improving the overall survival of post–radical nephrectomy patients," he concluded.

Dr. Sejima reported having no disclosures.

ORLANDO – Absence of comorbidities, larger remnant kidney volume/body surface area ratio, and larger tumor diameter were significant predictors of mild renal insufficiency following radical nephrectomy, and smaller tumor diameter was a significant predictor of severe renal insufficiency in an analysis of 53 cases.

"This is the first report to identify the remnant kidney volume/body surface area (RKV/BSA) ratio as a promising predictor of post–radical nephrectomy renal functional decline," according to Dr. Takehiro Sejima, a urologist at Tottori University, Yonago, Japan, whose research was featured in an "Outstanding Posters" session at the annual meeting of the American Urological Association.

At a cutoff value of 115, the RKV/BSA ratio had 47.6% sensitivity and 79.2% specificity for predicting mild renal insufficiency using a receiver operating characteristic curve, Dr. Sejima said.

A total of 21 patients categorized as having mild renal insufficiency and 32 patients categorized as having severe renal insufficiency were included in the study. Those with severe renal insufficiency had a significantly greater extent of global glomerulosclerosis, compared with those with mild renal insufficiency. Also, cardiovascular disease events occurred in 11 patients with severe renal insufficiency during up to 122.5 months of follow-up; no cardiovascular disease events occurred in those with mild renal insufficiency, he said.

Estimated glomerular filtration rates were measured preoperatively, and at 6-12 months after radical nephrectomy in 175 patients. Those with a greater than 20% drop in estimated glomerular filtration rates were classified as having mild renal insufficiency, and those with a percentage decline above 40% were classified as having severe renal insufficiency.

"Our results provide physicians and patients with a useful predictor of renal functional outcomes preoperatively. The consideration of post–radical nephrectomy medical management for the prevention of cardiovascular disease, except in mild renal insufficiency patients, should be a future step toward improving the overall survival of post–radical nephrectomy patients," he concluded.

Dr. Sejima reported having no disclosures.

Surgical mesh products used for transvaginal repair of pelvic organ prolapse would be reclassified as high-risk devices, and manufacturers would have to submit approval applications, under a proposed order issued by the Food and Drug Administration.

These proposals address the serious health risks that have been associated with surgical mesh in this setting, and reflect the recommendations made by the FDA’s Obstetrics and Gynecology Devices panel at a meeting in September 2011, according to the FDA statement announcing the proposal issued on April 29.

"If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP [pelvic organ prolapse] repair," Dr. William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in the statement.

The proposal to categorize these devices as class III devices is "based on the tentative determination that general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of these devices, and there is sufficient information to establish special controls to provide such assurance," according to the FDA document that is being published in the Federal Register.

Surgical mesh products have been regulated as class II, moderate-risk devices, which usually are exempt from premarket review; approval of class II devices is based on whether the FDA determines that the device is "substantially equivalent" to a similar device already on the market. Class III devices require safety and effectiveness data to be submitted and reviewed for approval.

The FDA issued notifications about serious adverse events associated with the use of surgical mesh devices to repair POP in 2008 and 2011, which have included mesh erosion through the vagina, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems – as well as recurrent prolapse, neuromuscular problems, and vaginal scarring/shrinkage.

The FDA is also proposing that the urogynecologic surgical instruments that are included in the mesh implant kits be reclassified from low-risk (class I) to moderate-risk devices. The agency has identified risks associated with the use of these devices to include organ perforation or injury and bleeding, as well as "damage to blood vessels, nerves, connective tissue, and other structures." Such injuries may be due to "improperly designed and/or misused surgical mesh instrumentation," according to the document posted in the Federal Register.

Comments on the proposals can be submitted to the FDA for 90 days after the May 1 publication of the proposal in the Federal Register electronically, through www.regulations.gov; or can be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Include Docket No. FDA-2014-N-0297. As of May 1, the proposal will be available here.

[email protected]

Surgical mesh products used for transvaginal repair of pelvic organ prolapse would be reclassified as high-risk devices, and manufacturers would have to submit approval applications, under a proposed order issued by the Food and Drug Administration.

These proposals address the serious health risks that have been associated with surgical mesh in this setting, and reflect the recommendations made by the FDA’s Obstetrics and Gynecology Devices panel at a meeting in September 2011, according to the FDA statement announcing the proposal issued on April 29.

"If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP [pelvic organ prolapse] repair," Dr. William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in the statement.

The proposal to categorize these devices as class III devices is "based on the tentative determination that general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of these devices, and there is sufficient information to establish special controls to provide such assurance," according to the FDA document that is being published in the Federal Register.

Surgical mesh products have been regulated as class II, moderate-risk devices, which usually are exempt from premarket review; approval of class II devices is based on whether the FDA determines that the device is "substantially equivalent" to a similar device already on the market. Class III devices require safety and effectiveness data to be submitted and reviewed for approval.

The FDA issued notifications about serious adverse events associated with the use of surgical mesh devices to repair POP in 2008 and 2011, which have included mesh erosion through the vagina, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems – as well as recurrent prolapse, neuromuscular problems, and vaginal scarring/shrinkage.

The FDA is also proposing that the urogynecologic surgical instruments that are included in the mesh implant kits be reclassified from low-risk (class I) to moderate-risk devices. The agency has identified risks associated with the use of these devices to include organ perforation or injury and bleeding, as well as "damage to blood vessels, nerves, connective tissue, and other structures." Such injuries may be due to "improperly designed and/or misused surgical mesh instrumentation," according to the document posted in the Federal Register.

Comments on the proposals can be submitted to the FDA for 90 days after the May 1 publication of the proposal in the Federal Register electronically, through www.regulations.gov; or can be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Include Docket No. FDA-2014-N-0297. As of May 1, the proposal will be available here.

[email protected]

Surgical mesh products used for transvaginal repair of pelvic organ prolapse would be reclassified as high-risk devices, and manufacturers would have to submit approval applications, under a proposed order issued by the Food and Drug Administration.

These proposals address the serious health risks that have been associated with surgical mesh in this setting, and reflect the recommendations made by the FDA’s Obstetrics and Gynecology Devices panel at a meeting in September 2011, according to the FDA statement announcing the proposal issued on April 29.

"If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP [pelvic organ prolapse] repair," Dr. William Maisel, deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in the statement.

The proposal to categorize these devices as class III devices is "based on the tentative determination that general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of these devices, and there is sufficient information to establish special controls to provide such assurance," according to the FDA document that is being published in the Federal Register.

Surgical mesh products have been regulated as class II, moderate-risk devices, which usually are exempt from premarket review; approval of class II devices is based on whether the FDA determines that the device is "substantially equivalent" to a similar device already on the market. Class III devices require safety and effectiveness data to be submitted and reviewed for approval.

The FDA issued notifications about serious adverse events associated with the use of surgical mesh devices to repair POP in 2008 and 2011, which have included mesh erosion through the vagina, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems – as well as recurrent prolapse, neuromuscular problems, and vaginal scarring/shrinkage.

The FDA is also proposing that the urogynecologic surgical instruments that are included in the mesh implant kits be reclassified from low-risk (class I) to moderate-risk devices. The agency has identified risks associated with the use of these devices to include organ perforation or injury and bleeding, as well as "damage to blood vessels, nerves, connective tissue, and other structures." Such injuries may be due to "improperly designed and/or misused surgical mesh instrumentation," according to the document posted in the Federal Register.

Comments on the proposals can be submitted to the FDA for 90 days after the May 1 publication of the proposal in the Federal Register electronically, through www.regulations.gov; or can be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Include Docket No. FDA-2014-N-0297. As of May 1, the proposal will be available here.

[email protected]

A DNA methylation marker panel from urine sediments was superior to gold standard tests for predicting recurrence of bladder cancer, investigators reported April 1 in Clinical Cancer Research.

Eighty percent of patients with positive scores on the three-marker panel developed recurrent, biopsy-proven urothelial carcinoma after complete resection of the visible primary tumor (95% confidence interval, 62%-98%), reported Dr. Sheng-Fang Su of University of Southern California Norris Comprehensive Cancer Center, Los Angeles, and his associates.

The panel’s positive predictive value far exceeded the values for cytology (35%; 95% CI, 14%-56%) and cytoscopy (15%; 95% CI, 0-31%), the investigators reported (Clin. Cancer Res. 2014 [doi:10.1158/1078-0432.CCR-13-2637]).

©Sebastian Kaulitzki/thinkstockphotos.com

The prospective study enrolled 90 patients who had undergone transurethral resection of noninvasive urothelial carcinomas (Tis, Ta, T1; grade low high). Median age of patients was 69 years (range, 41-96). Patients with high-grade Ta/T1 tumors had received intravesical Bacillus Calmette-Guerin vaccine or mitomycin C at their physicians’ discretion.

The investigators performed cytology and extracted DNA from 368 urine and bladder wash specimens collected from patients over a seven-year period. Patients also underwent cytoscopy. The investigators used logistic regression to assess the sensitivity and specificity of various combinations of DNA methylation markers.

The optimal panel included a tumor-specific hypermethylated marker (SOX1), an epigenetic marker (IRAK3), and a field defect-associated hypomethylated marker (L1-MET), the researchers said. The panel’s sensitivity was 80% (95% CI, 60%-96%) and specificity was 97% (95% CI, 91%-100%), they reported. The negative predictive value of the panel (74%) resembled that of cytoscopy (80%) and cytology (76%), they said.

Dr. Su and his associates noted that previous marker tests were more sensitive than cytology, including the FDA-approved NMP-22, ImmunoCyst, and UroVysion tests. But these are expensive, labor-intensive, less specific, and benign urinary conditions can compromise their reliability, they added.

A panel like the one used in the study could help clinicians determine the appropriate frequency of follow-up cytology after bladder cancer resection, the investigators said. But they noted that the validation sets were not ideal and that the urine markers should be further explored in a larger, independent cohort.

The National Cancer Institute funded the research. One of the researchers, Dr. Jones, reported having been a consultant and advisory board member of Astex, Lilly, and Zymo. The other authors reported no conflicts of interest.

A DNA methylation marker panel from urine sediments was superior to gold standard tests for predicting recurrence of bladder cancer, investigators reported April 1 in Clinical Cancer Research.

Eighty percent of patients with positive scores on the three-marker panel developed recurrent, biopsy-proven urothelial carcinoma after complete resection of the visible primary tumor (95% confidence interval, 62%-98%), reported Dr. Sheng-Fang Su of University of Southern California Norris Comprehensive Cancer Center, Los Angeles, and his associates.

The panel’s positive predictive value far exceeded the values for cytology (35%; 95% CI, 14%-56%) and cytoscopy (15%; 95% CI, 0-31%), the investigators reported (Clin. Cancer Res. 2014 [doi:10.1158/1078-0432.CCR-13-2637]).

©Sebastian Kaulitzki/thinkstockphotos.com

The prospective study enrolled 90 patients who had undergone transurethral resection of noninvasive urothelial carcinomas (Tis, Ta, T1; grade low high). Median age of patients was 69 years (range, 41-96). Patients with high-grade Ta/T1 tumors had received intravesical Bacillus Calmette-Guerin vaccine or mitomycin C at their physicians’ discretion.

The investigators performed cytology and extracted DNA from 368 urine and bladder wash specimens collected from patients over a seven-year period. Patients also underwent cytoscopy. The investigators used logistic regression to assess the sensitivity and specificity of various combinations of DNA methylation markers.

The optimal panel included a tumor-specific hypermethylated marker (SOX1), an epigenetic marker (IRAK3), and a field defect-associated hypomethylated marker (L1-MET), the researchers said. The panel’s sensitivity was 80% (95% CI, 60%-96%) and specificity was 97% (95% CI, 91%-100%), they reported. The negative predictive value of the panel (74%) resembled that of cytoscopy (80%) and cytology (76%), they said.

Dr. Su and his associates noted that previous marker tests were more sensitive than cytology, including the FDA-approved NMP-22, ImmunoCyst, and UroVysion tests. But these are expensive, labor-intensive, less specific, and benign urinary conditions can compromise their reliability, they added.

A panel like the one used in the study could help clinicians determine the appropriate frequency of follow-up cytology after bladder cancer resection, the investigators said. But they noted that the validation sets were not ideal and that the urine markers should be further explored in a larger, independent cohort.

The National Cancer Institute funded the research. One of the researchers, Dr. Jones, reported having been a consultant and advisory board member of Astex, Lilly, and Zymo. The other authors reported no conflicts of interest.

A DNA methylation marker panel from urine sediments was superior to gold standard tests for predicting recurrence of bladder cancer, investigators reported April 1 in Clinical Cancer Research.

Eighty percent of patients with positive scores on the three-marker panel developed recurrent, biopsy-proven urothelial carcinoma after complete resection of the visible primary tumor (95% confidence interval, 62%-98%), reported Dr. Sheng-Fang Su of University of Southern California Norris Comprehensive Cancer Center, Los Angeles, and his associates.

The panel’s positive predictive value far exceeded the values for cytology (35%; 95% CI, 14%-56%) and cytoscopy (15%; 95% CI, 0-31%), the investigators reported (Clin. Cancer Res. 2014 [doi:10.1158/1078-0432.CCR-13-2637]).

©Sebastian Kaulitzki/thinkstockphotos.com

The prospective study enrolled 90 patients who had undergone transurethral resection of noninvasive urothelial carcinomas (Tis, Ta, T1; grade low high). Median age of patients was 69 years (range, 41-96). Patients with high-grade Ta/T1 tumors had received intravesical Bacillus Calmette-Guerin vaccine or mitomycin C at their physicians’ discretion.

The investigators performed cytology and extracted DNA from 368 urine and bladder wash specimens collected from patients over a seven-year period. Patients also underwent cytoscopy. The investigators used logistic regression to assess the sensitivity and specificity of various combinations of DNA methylation markers.

The optimal panel included a tumor-specific hypermethylated marker (SOX1), an epigenetic marker (IRAK3), and a field defect-associated hypomethylated marker (L1-MET), the researchers said. The panel’s sensitivity was 80% (95% CI, 60%-96%) and specificity was 97% (95% CI, 91%-100%), they reported. The negative predictive value of the panel (74%) resembled that of cytoscopy (80%) and cytology (76%), they said.

Dr. Su and his associates noted that previous marker tests were more sensitive than cytology, including the FDA-approved NMP-22, ImmunoCyst, and UroVysion tests. But these are expensive, labor-intensive, less specific, and benign urinary conditions can compromise their reliability, they added.

A panel like the one used in the study could help clinicians determine the appropriate frequency of follow-up cytology after bladder cancer resection, the investigators said. But they noted that the validation sets were not ideal and that the urine markers should be further explored in a larger, independent cohort.

The National Cancer Institute funded the research. One of the researchers, Dr. Jones, reported having been a consultant and advisory board member of Astex, Lilly, and Zymo. The other authors reported no conflicts of interest.

SCOTTSDALE, ARIZ. – Early hospital readmissions are not good for patients and can be terrible for a hospital’s bottom line, but at least one cause of readmission – urinary retention after surgery – can be significantly reduced.

"Postoperative urinary retention is a prevalent and mostly avoidable complication," said Dr. Sarita Khemani, a surgical comanagement hospitalist at Stanford (Calif.) University Medical Center.

Postoperative urinary retention can be defined as the inability to void in the presence of symptoms or bladder distension. However, as some patients may retain urine without feeling symptoms or the urge to void, it can also be defined as the inability to void with a bladder volume greater than 500 mL, or the presence of a postvoid residual volume greater than 200 mL on bladder scan, she said at a meeting on perioperative medicine sponsored by the University of Miami.

Identify high-risk patients

"For management, identifying the high-risk patient is very important," said Dr. Khemani.

She and her colleagues are working to develop a scoring system for identifying patients at risk for postoperative retention, she noted.

Depending on the risk factor, patients may require continued use of benign prostatic hyperplasia (BPH) medications (a strategy currently under clinical investigation), multimodal anesthesia, monitoring of IV fluids during and after surgery, and, when necessary, catheterization.

Frontline Medical News

"There is really no consensus as to what is the best catheterization strategy we should use when it comes to urinary retention," Dr. Khemani said.

Low-risk patients undergoing outpatient procedures can be safely sent home without voiding, she said. High-risk patients undergoing ambulatory surgery can be managed with intermittent catheterization.

Patients who are undergoing major but uncomplicated surgery but are at low risk for postoperative retention do not generally need to have Foley catheters placed before surgery. Indwelling catheters should be limited, if possible, to 24 hours after surgery, and the patient can be managed with bladder scans every 6 hours if needed.

Patients scheduled for extensive, complicated procedures and those at high risk may require an indwelling catheter for up to 5 days after surgery. Studies have shown that in these patients early catheter removal actually increases the risk for postoperative urinary retention, Dr. Khemani said.

"It really needs to be followed by bladder scanning very closely, every 6 hours, to try to prevent overdistention and complications after that," she said.

The incidence of postoperative urinary retention among general surgery patients is 3.8%, but can range as high 70% after orthopedic surgery, 50% after anorectal procedures, 40% following spinal surgeries, and 38% after herniorrhaphy, Dr. Khemani said.

Preoperative risk factors for urinary retention after surgery include age over 50; male sex; history of retention; BPH; history of diabetes, stroke, or spinal lesions; or use of drugs such anticholinergic agents or beta-blockers.

Intraoperative and postoperative risk factors include the type and duration of surgery, anesthesia (especially spinal and epidural anethesias), systemic analgesia with opioids (especially patient-controlled analgesia, or PCA), and the use of intraoperative intravenous fluids. High IV fluid infusion causes rapid distention of the bladder detrusor muscles, leading to inability of the muscles to contract after surgery, Dr. Khemani noted.

Complications of postoperative urinary retention can include:

• Autonomic responses to bladder distention, leading to effects such as bradycardia, hypotension, vomiting, and delirium in some elderly patients.

• Infectious complications – urinary tract infections, sepsis, and joint infections.

• Prolonged need for catheterization.

• Bladder dysfunction.

A recent systematic review of drugs for treatment of urinary retention after surgery in adults found that of seven studies involving a total of 494 patients, neither cholinergic agents, alpha blockers, nor sedatives made a significant difference in reducing the incidence of retention. Only prostaglandins, and only when those agents were given intravesically, appeared to offer any benefit, the authors found.

"At this point we definitely need more studies to look at pharmacological alternatives to catheterization for treatment and prevention of this condition," Dr. Khemani concluded.

She reported having no financial disclosures.

SCOTTSDALE, ARIZ. – Early hospital readmissions are not good for patients and can be terrible for a hospital’s bottom line, but at least one cause of readmission – urinary retention after surgery – can be significantly reduced.

"Postoperative urinary retention is a prevalent and mostly avoidable complication," said Dr. Sarita Khemani, a surgical comanagement hospitalist at Stanford (Calif.) University Medical Center.

Postoperative urinary retention can be defined as the inability to void in the presence of symptoms or bladder distension. However, as some patients may retain urine without feeling symptoms or the urge to void, it can also be defined as the inability to void with a bladder volume greater than 500 mL, or the presence of a postvoid residual volume greater than 200 mL on bladder scan, she said at a meeting on perioperative medicine sponsored by the University of Miami.

Identify high-risk patients

"For management, identifying the high-risk patient is very important," said Dr. Khemani.

She and her colleagues are working to develop a scoring system for identifying patients at risk for postoperative retention, she noted.

Depending on the risk factor, patients may require continued use of benign prostatic hyperplasia (BPH) medications (a strategy currently under clinical investigation), multimodal anesthesia, monitoring of IV fluids during and after surgery, and, when necessary, catheterization.

Frontline Medical News

"There is really no consensus as to what is the best catheterization strategy we should use when it comes to urinary retention," Dr. Khemani said.

Low-risk patients undergoing outpatient procedures can be safely sent home without voiding, she said. High-risk patients undergoing ambulatory surgery can be managed with intermittent catheterization.

Patients who are undergoing major but uncomplicated surgery but are at low risk for postoperative retention do not generally need to have Foley catheters placed before surgery. Indwelling catheters should be limited, if possible, to 24 hours after surgery, and the patient can be managed with bladder scans every 6 hours if needed.

Patients scheduled for extensive, complicated procedures and those at high risk may require an indwelling catheter for up to 5 days after surgery. Studies have shown that in these patients early catheter removal actually increases the risk for postoperative urinary retention, Dr. Khemani said.

"It really needs to be followed by bladder scanning very closely, every 6 hours, to try to prevent overdistention and complications after that," she said.

The incidence of postoperative urinary retention among general surgery patients is 3.8%, but can range as high 70% after orthopedic surgery, 50% after anorectal procedures, 40% following spinal surgeries, and 38% after herniorrhaphy, Dr. Khemani said.

Preoperative risk factors for urinary retention after surgery include age over 50; male sex; history of retention; BPH; history of diabetes, stroke, or spinal lesions; or use of drugs such anticholinergic agents or beta-blockers.

Intraoperative and postoperative risk factors include the type and duration of surgery, anesthesia (especially spinal and epidural anethesias), systemic analgesia with opioids (especially patient-controlled analgesia, or PCA), and the use of intraoperative intravenous fluids. High IV fluid infusion causes rapid distention of the bladder detrusor muscles, leading to inability of the muscles to contract after surgery, Dr. Khemani noted.

Complications of postoperative urinary retention can include:

• Autonomic responses to bladder distention, leading to effects such as bradycardia, hypotension, vomiting, and delirium in some elderly patients.

• Infectious complications – urinary tract infections, sepsis, and joint infections.

• Prolonged need for catheterization.

• Bladder dysfunction.

A recent systematic review of drugs for treatment of urinary retention after surgery in adults found that of seven studies involving a total of 494 patients, neither cholinergic agents, alpha blockers, nor sedatives made a significant difference in reducing the incidence of retention. Only prostaglandins, and only when those agents were given intravesically, appeared to offer any benefit, the authors found.

"At this point we definitely need more studies to look at pharmacological alternatives to catheterization for treatment and prevention of this condition," Dr. Khemani concluded.

She reported having no financial disclosures.

SCOTTSDALE, ARIZ. – Early hospital readmissions are not good for patients and can be terrible for a hospital’s bottom line, but at least one cause of readmission – urinary retention after surgery – can be significantly reduced.

"Postoperative urinary retention is a prevalent and mostly avoidable complication," said Dr. Sarita Khemani, a surgical comanagement hospitalist at Stanford (Calif.) University Medical Center.

Postoperative urinary retention can be defined as the inability to void in the presence of symptoms or bladder distension. However, as some patients may retain urine without feeling symptoms or the urge to void, it can also be defined as the inability to void with a bladder volume greater than 500 mL, or the presence of a postvoid residual volume greater than 200 mL on bladder scan, she said at a meeting on perioperative medicine sponsored by the University of Miami.

Identify high-risk patients

"For management, identifying the high-risk patient is very important," said Dr. Khemani.

She and her colleagues are working to develop a scoring system for identifying patients at risk for postoperative retention, she noted.

Depending on the risk factor, patients may require continued use of benign prostatic hyperplasia (BPH) medications (a strategy currently under clinical investigation), multimodal anesthesia, monitoring of IV fluids during and after surgery, and, when necessary, catheterization.

Frontline Medical News

"There is really no consensus as to what is the best catheterization strategy we should use when it comes to urinary retention," Dr. Khemani said.

Low-risk patients undergoing outpatient procedures can be safely sent home without voiding, she said. High-risk patients undergoing ambulatory surgery can be managed with intermittent catheterization.

Patients who are undergoing major but uncomplicated surgery but are at low risk for postoperative retention do not generally need to have Foley catheters placed before surgery. Indwelling catheters should be limited, if possible, to 24 hours after surgery, and the patient can be managed with bladder scans every 6 hours if needed.

Patients scheduled for extensive, complicated procedures and those at high risk may require an indwelling catheter for up to 5 days after surgery. Studies have shown that in these patients early catheter removal actually increases the risk for postoperative urinary retention, Dr. Khemani said.

"It really needs to be followed by bladder scanning very closely, every 6 hours, to try to prevent overdistention and complications after that," she said.

The incidence of postoperative urinary retention among general surgery patients is 3.8%, but can range as high 70% after orthopedic surgery, 50% after anorectal procedures, 40% following spinal surgeries, and 38% after herniorrhaphy, Dr. Khemani said.

Preoperative risk factors for urinary retention after surgery include age over 50; male sex; history of retention; BPH; history of diabetes, stroke, or spinal lesions; or use of drugs such anticholinergic agents or beta-blockers.

Intraoperative and postoperative risk factors include the type and duration of surgery, anesthesia (especially spinal and epidural anethesias), systemic analgesia with opioids (especially patient-controlled analgesia, or PCA), and the use of intraoperative intravenous fluids. High IV fluid infusion causes rapid distention of the bladder detrusor muscles, leading to inability of the muscles to contract after surgery, Dr. Khemani noted.

Complications of postoperative urinary retention can include:

• Autonomic responses to bladder distention, leading to effects such as bradycardia, hypotension, vomiting, and delirium in some elderly patients.

• Infectious complications – urinary tract infections, sepsis, and joint infections.

• Prolonged need for catheterization.

• Bladder dysfunction.

A recent systematic review of drugs for treatment of urinary retention after surgery in adults found that of seven studies involving a total of 494 patients, neither cholinergic agents, alpha blockers, nor sedatives made a significant difference in reducing the incidence of retention. Only prostaglandins, and only when those agents were given intravesically, appeared to offer any benefit, the authors found.

"At this point we definitely need more studies to look at pharmacological alternatives to catheterization for treatment and prevention of this condition," Dr. Khemani concluded.

She reported having no financial disclosures.

MIAMI BEACH – Renal insufficiency significantly increased the risk of major complications after liver surgery.

However, it wasn’t associated with an increased risk of 90-day mortality, suggesting that patients with poor renal function shouldn’t be ruled out as surgical candidates, Dr. Malcolm Squires III said at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.

"While they may be at a potential risk of major complications – renal failure and respiratory failure – we are ultimately able to get these patients through the postoperative period without any significant increase in mortality," said Dr. Squires of Emory University, Atlanta.

He presented a large retrospective study that examined postoperative outcomes in 1,170 patients (mean age, 57 years) who underwent major hepatectomy at three national academic hospitals from 2000 to 2012. The study determined the link between major complications and preoperative serum creatinine levels. These levels were dichotomized as normal (1.8 mg/dL or less) and elevated (greater than 1.8 mg/dL).

Most patients (1,148) had normal levels; only 22 had elevated serum creatinine, considered to be reflective of chronic renal insufficiency.

Pathology included cholangiocarcinoma, hepatocellular carcinoma, metastatic colorectal cancer, other cancers, and benign lesions. Cirrhosis was present in 4% and steatosis in 39%.

Most (83%) had open surgery; 17% had a laparoscopic procedure. The mean blood loss was 510 cc; 25% needed an intraoperative blood transfusion.

Postoperative complications arose in 56% of the group. A quarter (24%) had a major complication, including renal failure (3%) and respiratory failure (5%). Three-month mortality in the entire group was 5%.

In a multivariate model, preoperative renal insufficiency conferred a fourfold increased risk of developing a major postoperative complication. Other significant predictors were a high American Society of Anesthesiologists classification score (odds ratio, 1.6), having a bile duct resection (OR, 1.7), and a low preoperative albumin level (OR, 1.6).

Renal insufficiency also significantly predicted postoperative respiratory failure (OR, 4.4). Other predictors of respiratory failure were older age (OR, 1.06) and cirrhosis (OR, 6.6).

Renal insufficiency was also a significant risk factor for renal failure, increasing the odds by 4.6.

The biggest predictor of 90-day mortality was hepatitis C, which conferred a ninefold increased risk. Cardiac disease also significantly increased the risk (OR, 2), as did bile duct resection (OR, 2.3), intraoperative transfusion (OR, 2) and cirrhosis (OR, 4.7).

Preoperative renal insufficiency did not significantly increase the risk of death, Dr. Squires noted.

"These findings should be taken into consideration when evaluating patients with preoperative renal insufficiency for hepatic resection," he said. "Careful patient selection and appropriate preoperative counseling are critical."

Dr. Squires had no financial disclosures.

[email protected]

MIAMI BEACH – Renal insufficiency significantly increased the risk of major complications after liver surgery.

However, it wasn’t associated with an increased risk of 90-day mortality, suggesting that patients with poor renal function shouldn’t be ruled out as surgical candidates, Dr. Malcolm Squires III said at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.

"While they may be at a potential risk of major complications – renal failure and respiratory failure – we are ultimately able to get these patients through the postoperative period without any significant increase in mortality," said Dr. Squires of Emory University, Atlanta.

He presented a large retrospective study that examined postoperative outcomes in 1,170 patients (mean age, 57 years) who underwent major hepatectomy at three national academic hospitals from 2000 to 2012. The study determined the link between major complications and preoperative serum creatinine levels. These levels were dichotomized as normal (1.8 mg/dL or less) and elevated (greater than 1.8 mg/dL).

Most patients (1,148) had normal levels; only 22 had elevated serum creatinine, considered to be reflective of chronic renal insufficiency.

Pathology included cholangiocarcinoma, hepatocellular carcinoma, metastatic colorectal cancer, other cancers, and benign lesions. Cirrhosis was present in 4% and steatosis in 39%.

Most (83%) had open surgery; 17% had a laparoscopic procedure. The mean blood loss was 510 cc; 25% needed an intraoperative blood transfusion.

Postoperative complications arose in 56% of the group. A quarter (24%) had a major complication, including renal failure (3%) and respiratory failure (5%). Three-month mortality in the entire group was 5%.

In a multivariate model, preoperative renal insufficiency conferred a fourfold increased risk of developing a major postoperative complication. Other significant predictors were a high American Society of Anesthesiologists classification score (odds ratio, 1.6), having a bile duct resection (OR, 1.7), and a low preoperative albumin level (OR, 1.6).

Renal insufficiency also significantly predicted postoperative respiratory failure (OR, 4.4). Other predictors of respiratory failure were older age (OR, 1.06) and cirrhosis (OR, 6.6).

Renal insufficiency was also a significant risk factor for renal failure, increasing the odds by 4.6.

The biggest predictor of 90-day mortality was hepatitis C, which conferred a ninefold increased risk. Cardiac disease also significantly increased the risk (OR, 2), as did bile duct resection (OR, 2.3), intraoperative transfusion (OR, 2) and cirrhosis (OR, 4.7).

Preoperative renal insufficiency did not significantly increase the risk of death, Dr. Squires noted.

"These findings should be taken into consideration when evaluating patients with preoperative renal insufficiency for hepatic resection," he said. "Careful patient selection and appropriate preoperative counseling are critical."

Dr. Squires had no financial disclosures.

[email protected]

MIAMI BEACH – Renal insufficiency significantly increased the risk of major complications after liver surgery.

However, it wasn’t associated with an increased risk of 90-day mortality, suggesting that patients with poor renal function shouldn’t be ruled out as surgical candidates, Dr. Malcolm Squires III said at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.

"While they may be at a potential risk of major complications – renal failure and respiratory failure – we are ultimately able to get these patients through the postoperative period without any significant increase in mortality," said Dr. Squires of Emory University, Atlanta.

He presented a large retrospective study that examined postoperative outcomes in 1,170 patients (mean age, 57 years) who underwent major hepatectomy at three national academic hospitals from 2000 to 2012. The study determined the link between major complications and preoperative serum creatinine levels. These levels were dichotomized as normal (1.8 mg/dL or less) and elevated (greater than 1.8 mg/dL).

Most patients (1,148) had normal levels; only 22 had elevated serum creatinine, considered to be reflective of chronic renal insufficiency.

Pathology included cholangiocarcinoma, hepatocellular carcinoma, metastatic colorectal cancer, other cancers, and benign lesions. Cirrhosis was present in 4% and steatosis in 39%.

Most (83%) had open surgery; 17% had a laparoscopic procedure. The mean blood loss was 510 cc; 25% needed an intraoperative blood transfusion.

Postoperative complications arose in 56% of the group. A quarter (24%) had a major complication, including renal failure (3%) and respiratory failure (5%). Three-month mortality in the entire group was 5%.

In a multivariate model, preoperative renal insufficiency conferred a fourfold increased risk of developing a major postoperative complication. Other significant predictors were a high American Society of Anesthesiologists classification score (odds ratio, 1.6), having a bile duct resection (OR, 1.7), and a low preoperative albumin level (OR, 1.6).

Renal insufficiency also significantly predicted postoperative respiratory failure (OR, 4.4). Other predictors of respiratory failure were older age (OR, 1.06) and cirrhosis (OR, 6.6).

Renal insufficiency was also a significant risk factor for renal failure, increasing the odds by 4.6.

The biggest predictor of 90-day mortality was hepatitis C, which conferred a ninefold increased risk. Cardiac disease also significantly increased the risk (OR, 2), as did bile duct resection (OR, 2.3), intraoperative transfusion (OR, 2) and cirrhosis (OR, 4.7).

Preoperative renal insufficiency did not significantly increase the risk of death, Dr. Squires noted.

"These findings should be taken into consideration when evaluating patients with preoperative renal insufficiency for hepatic resection," he said. "Careful patient selection and appropriate preoperative counseling are critical."

Dr. Squires had no financial disclosures.

[email protected]