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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
A randomized trial of urodynamic testing before stress-incontinence surgery
New England Journal of Medicine, Volume 366, No. 21, Year 2012
Notification
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Description
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 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. CONCLUSIONS: 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.) Copyright © 2012 Massachusetts Medical Society.
Authors & Co-Authors
Nager, Charles W.
United States, La Jolla
University of California, San Diego
Brubaker, Linda T.
United States, Chicago
Loyola University Chicago
Litman, Heather J.
United States, Watertown
New England Research Institutes
Zyczynski, Halina M.
United States, Pittsburgh
University of Pittsburgh
Amundsen, Cindy Louise
United States, Durham
Duke University
Sirls, Larry Thomas
United States, Royal Oak
William Beaumont Hospital
Norton, Peggy A.
United States, Salt Lake City
The University of Utah
Arisco, Amy M.
United States, San Antonio
The University of Texas at San Antonio
Chai, Toby C.
United States, Baltimore
University of Maryland, Baltimore Umb
Zimmern, Philippe E.
United States, Dallas
Ut Southwestern Medical Center
Dandreo, Kimberly J.
United States, Watertown
New England Research Institutes
Menefee, Shawn Adam
United States, Oakland
Kaiser Permanente
Kenton, Kimberly S.
United States, Chicago
Loyola University Chicago
Lowder, Jerry L.
United States, Pittsburgh
University of Pittsburgh
Richter, Holly Elizabeth
United States, Birmingham
The University of Alabama at Birmingham
Khandwala, Salil
United States, Royal Oak
William Beaumont Hospital
Kraus, Stephen R.
United States, San Antonio
The University of Texas at San Antonio
Johnson, Harry W.
United States, Baltimore
University of Maryland, Baltimore Umb
Lemack, Gary E.
United States, Dallas
Ut Southwestern Medical Center
Mihova, Marina S.
United States, Watertown
New England Research Institutes
Albo, Michael Edward
United States, La Jolla
University of California, San Diego
Mueller, Elizabeth Rose
United States, Chicago
Loyola University Chicago
Sutkin, Gary
United States, Pittsburgh
University of Pittsburgh
Rozanski, Thomas A.
United States, San Antonio
The University of Texas at San Antonio
Tennstedt, Sharon L.
United States, Watertown
New England Research Institutes
Leng, Wendy W.
Unknown Affiliation
Stoddard, Anne M.
Unknown Affiliation
Chang, Debuene
Unknown Affiliation
Rasooly, Rebekah S.
Unknown Affiliation
Burgio, Kathryn Larsen
Unknown Affiliation
Fischer, Melissa C.
Unknown Affiliation
FitzGerald, Mary Pat
Unknown Affiliation
Ghetti, Chiara C.
Unknown Affiliation
Goode, Patricia S.
Unknown Affiliation
Holley, Robert L.
Unknown Affiliation
Kahn, Margie A.
Unknown Affiliation
Luber, Karl M.
Unknown Affiliation
Markland, Alayne D.
Unknown Affiliation
Moalli, Pamela A.
Unknown Affiliation
Nagaraju, Pradeep
Unknown Affiliation
Peters, Kenneth M.
Unknown Affiliation
Schaffer, Joseph I.
Unknown Affiliation
Burr, Laura
Unknown Affiliation
Columbo, Jesse A.
Unknown Affiliation
Dickinson, Tamara
Unknown Affiliation
Dinh, Rosanna
Unknown Affiliation
Gruss, Judy A.
Unknown Affiliation
Howell, Alice
Unknown Affiliation
Jayachandran, Chaandini J.
Unknown Affiliation
Jesse, Kathy
Unknown Affiliation
Leemon, Barbara
Unknown Affiliation
Mislanovich, Karen
Unknown Affiliation
Prather, Caren
Unknown Affiliation
Tulke, Mary
Unknown Affiliation
Willingham, Robin
Unknown Affiliation
Woodson, Kimberly
Unknown Affiliation
Zazueta-Damian, Gisselle
Unknown Affiliation
Huang, Liyuan
Unknown Affiliation
Kowalski, Rose
Unknown Affiliation
Tanwar, Kerry L.
Unknown Affiliation
Tennstedt, Sharon L.
Unknown Affiliation
Xu, Yan
Unknown Affiliation
Clemens, James Quentin
Unknown Affiliation
Abrams, Paul H.
Unknown Affiliation
Bland, Deirdre R.
Unknown Affiliation
Boone, Timothy B.
Unknown Affiliation
Connett, John E.
Unknown Affiliation
Fenner, Dee E.
Unknown Affiliation
Henderson, William G.
Unknown Affiliation
Kelsey, Sheryl F.
Unknown Affiliation
Lightner, Deborah J.
Unknown Affiliation
Myers, Deborah L.
Unknown Affiliation
Wadie, Bassem
Unknown Affiliation
Daneshgari, Firouz
Unknown Affiliation
Pocock, Stuart J.
Unknown Affiliation
Statistics
Citations: 341
Authors: 75
Affiliations: 15
Identifiers
Doi:
10.1056/NEJMoa1113595
ISSN:
00284793
Research Areas
Disability
Health System And Policy
Maternal And Child Health
Noncommunicable Diseases
Participants Gender
Female