作者
Charles W Nager, Linda Brubaker, Heather J Litman, Halina M Zyczynski, R Edward Varner, Cindy Amundsen, Larry T Sirls, Peggy A Norton, Amy M Arisco, Toby C Chai, Philippe Zimmern, Matthew D Barber, Kimberly J Dandreo, Shawn A Menefee, Kimberly Kenton, Jerry Lowder, Holly E Richter, Salil Khandwala, Ingrid Nygaard, Stephen R Kraus, Harry W Johnson, Gary E Lemack, Marina Mihova, Michael E Albo, Elizabeth Mueller, Gary Sutkin, Tracey S Wilson, Yvonne Hsu, Thomas A Rozanski, Leslie M Rickey, David Rahn, Sharon Tennstedt, John W Kusek, E Ann Gormley
发表日期
2012/5/24
期刊
New England Journal of Medicine
卷号
366
期号
21
页码范围
1987-1997
出版商
Massachusetts Medical Society
简介
Background
Urodynamic studies are commonly performed in women before surgery for stress urinary incontinence, but there is no good evidence that they improve outcomes.
Methods
We performed a multicenter, randomized, noninferiority trial involving women with uncomplicated, demonstrable stress urinary incontinence to compare outcomes after preoperative office evaluation and urodynamic tests or evaluation only. The primary outcome was treatment success at 12 months, defined as a reduction in the score on the Urogenital Distress Inventory of 70% or more and a response of “much better” or “very much better” on the Patient Global Impression of Improvement. The predetermined noninferiority margin was 11 percentage points.
Results
A total of 630 women were randomly assigned to undergo office evaluation with urodynamic tests or evaluation only (315 per group); the proportion in whom treatment …
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CW Nager, L Brubaker, HJ Litman, HM Zyczynski… - New England Journal of Medicine, 2012