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In stress continent women, prophylactic placement of a midurethral sling at the time of vaginal prolapse repair significantly decreases the development of bothersome urinary incontinence, even after allowing for delayed incontinence intervention.
Glasgow, Scotland-In stress continent women, prophylactic placement of a midurethral sling (MUS) at the time of vaginal prolapse repair significantly decreases the development of bothersome urinary incontinence, even after allowing for delayed incontinence intervention, according to the results of a prospective, multicenter, randomized, controlled trial.
Data from the OPUS (Outcomes following vaginal Prolapse repair and mid Urethral Sling) trial were presented by John T. Wei, MD, MS, at the International Continence Society annual meeting in Glasgow, Scotland. Undertaken by the Pelvic Floor Disorders Network, OPUS randomized 337 stress continent women with symptomatic stage 2-4 anterior vaginal prolapse to undergo prophylactic MUS surgery (TVT, Ethicon, Somerville, NJ) or sham vaginal incision. Surgeons could choose the method of prolapse repair, but had to declare the procedure preoperatively, and they all had to demonstrate proficiency with the MUS procedure.
QoL measures favor MUS group
Quality of life data showed significant differences favoring the MUS group in measures relating to urinary incontinence and stress incontinence, but no differences between groups in subscales for other pelvic or pain symptoms. Safety data showed significantly higher rates of adverse events typically associated with MUS surgery in the prophylactic MUS group compared with controls, but no significant differences between groups in rates of serious or unexpected adverse events.
"Management of women bothered by anterior vaginal prolapse but who are stress continent is a common clinical dilemma, and there has been no high-level evidence to guide treatment decisions," said Dr. Wei, professor of urology at the University of Michigan, Ann Arbor. "The OPUS trial addressed this gap, and its results show that prophylactic MUS surgery has a statistically and clinically significant benefit for reducing the development of urinary incontinence."
The two study arms were well-matched in their baseline characteristics and type of prolapse repair. About two-thirds of women had stage 3 prolapse, one-third had a positive stress test, and the majority in each group had an anterior repair with apical suspension.
An analysis of the urinary incontinence endpoint with women divided based on results of their baseline cough stress test showed a trend for prophylactic MUS to be more beneficial in women with a positive versus a negative cough test.
"Some surgeons place a midurethral sling at the time of prolapse repair only in women with a positive cough stress test. While the OPUS results provide modest evidence suggesting these women may benefit more, prophylactic MUS was effective regardless of the baseline cough stress test," Dr. Wei said.
In order to assess the magnitude of nonparticipation bias on the outcomes, data were also analyzed from a "patient preference cohort" consisting of 129 women who were screened for study participation and eligible for randomization but declined. Half of the women chose to have a prophylactic sling and when compared with those who chose a delayed strategy, the outcomes were similar to those found in the randomized cohort.