Major Finding: One year after surgery for urinary incontinence with retropubic or transobturator midurethral slings, results were similar in objective cure rates (81% vs. 78%) and subjective cure rates (62% vs. 56%), but various adverse events differed significantly between groups.
Data Source: Randomized, multicenter trial in 597 women.
Disclosures: The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases and by the National Institute of Child Health and Human Development. Dr. Richter said the investigators have no pertinent conflicts of interest.
SAN FRANCISCO — One year after surgery for stress urinary incontinence with retropubic or transobturator midurethral slings, objective and subjective cure rates were equivalent for the two approaches but rates of various adverse events differed significantly in a randomized, multicenter trial in 597 women.
“This trial gives us more information regarding equivalency in certain outcomes and gives us much more information regarding how to counsel our patients with respect to choosing treatment” by considering their risks for various adverse events, Dr. Holly E. Richter said at the meeting.
Unadjusted rates for objective cure were 81% for the retropubic group and 78% for the transobturator group. Objective cure rates after the site of surgery was controlled for were 82% for the retropubic group and 80% for the transobturator group, reported Dr. Richter of the University of Alabama at Birmingham. Objective cure was defined as a negative stress test result, a negative 24-hour pad test result, and no retreatment.
Subjective cure rates were 62% in the retropubic group and 56% in the transobturator group, both for the unadjusted rate and after the surgery site was controlled for. Subjective cure was defined as no patient reports of stress urinary incontinence symptoms, no leakage episodes in a 3-day voiding diary, and no retreatment.
Patient satisfaction was similar between groups—86% with retropubic midurethral sling and 90% with transobturator midurethral sling, Dr. Richter and her associates in the Urinary Incontinence Treatment Network found.
Adverse events that occurred significantly more often in the retropubic group compared with the transobturator group included voiding dysfunction requiring surgical intervention (9 events vs. none), and postoperative urinary tract infection (46 events vs. 27). Only patients in the retropubic group had bladder perforations—15 events vs. none in the transobturator group, Dr. Richter reported.
Adverse events that occurred significantly more often in the transobturator group than in the retropubic group included neurologic symptoms (31 events vs. 15), with the majority in the upper leg (20 and 4 events, respectively). Vaginal perforations were more likely in the transobturator group—13 events vs. 6—with in-to-out perforations more common (10 and 3 events) than out-to-in perforations.
“What this trial gives us is more information with which to counsel our patients and individualize treatment. There may be some patients, for example, that have some baseline neurologic symptoms, and you want to stay away from a transobturator approach. And there may be some women, for example, that are Valsalva voiders. They have a problem with voiding after a sling procedure, and you may want to stay away from a retropubic approach,” Dr. Richter said.
Women could enroll in the trial if they had predominant stress urinary incontinence symptoms, demonstrated leakage on cough stress tests, and were clinically eligible for both procedures. The only significant difference at baseline between groups was in the mean Valsalva leak point pressure—114 cm of water in the retropubic group vs. 124 cm of water in the transobturator group.