Urodynamic studies are commonly performed in women before surgery for stress urinary incontinence, but there is no good evidence that they improve outcomes.
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.
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 was successful was 76.9% in the urodynamic-testing group versus 77.2% in the evaluation-only group (difference, -0.3 percentage points; 95% confidence interval, -7.5 to 6.9), which was consistent with noninferiority. There were no significant between-group differences in secondary measures of incontinence severity, quality of life, patient satisfaction, rates of positive provocative stress tests, voiding dysfunction, or adverse events. Women who underwent urodynamic tests were significantly less likely to receive a diagnosis of overactive bladder and more likely to receive a diagnosis of voiding-phase dysfunction, but these changes did not lead to significant between-group differences in treatment selection or outcomes.
For women with uncomplicated, demonstrable stress urinary incontinence, preoperative office evaluation alone was not inferior to evaluation with urodynamic testing for outcomes at 1 year. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT00803959 .).
Written by:
Nager CW, Brubaker L, Litman HJ, Zyczynski HM, Varner RE, Amundsen C, Sirls LT, Norton PA, Arisco AM, Chai TC, Zimmern P, Barber MD, Dandreo KJ, Menefee SA, Kenton K, Lowder J, Richter HE, Khandwala S, Nygaard I, Kraus SR, Johnson HW, Lemack GE, Mihova M, Albo ME, Mueller E, Sutkin G, Wilson TS, Hsu Y, Rozanski TA, Rickey LM, Rahn D, Tennstedt S, Kusek JW, Gormley EA; the Urinary Incontinence Treatment Network. Are you the author?
From the University of California at San Diego (C.W.N., M.E.A.) and Kaiser Permanente Southern California (S.A.M.) - both in San Diego; Loyola University, Chicago (L.B., K.K., E.M.); New England Research Institutes, Watertown, MA (H.J.L., K.J.D., M.M., S.T.); the University of Pittsburgh, Magee-Womens Hospital, Pittsburgh (H.M.Z., J.L., G.S.); the University of Alabama at Birmingham, Birmingham (R.E.V., H.E.R., T.S.W.); Duke University, Durham, NC (C.A.); William Beaumont Hospital, Royal Oak, and Oakwood Hospital, Dearborn (L.T.S, S.K.) - both in Michigan; the University of Utah, Salt Lake City (P.A.N., I.N., Y.H.); the University of Texas, San Antonio (A.M.A., S.R.K., T.A.R.); the University of Maryland, Baltimore (T.C.C., H.W.J., L.M.R.); the University of Texas Southwestern Medical Center, Dallas (P.Z., G.E.L., D.R.); Cleveland Clinic, Cleveland (M.D.B.); the National Institutes of Health, Bethesda, MD (J.W.K.); and Dartmouth-Hitchcock Medical Center, Lebanon, NH (E.A.G.).
Reference: N Engl J Med. 2012 May 2. [Epub ahead of print]
doi: 10.1056/nejmoa1113595
PubMed Abstract
PMID: 22551104
View the full text article in New England Journal of Medicine
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