A randomized trial of urodynamic testing before stress-incontinence surgery

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. KrausHarry 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

Research output: Contribution to journalArticle

241 Citations (Scopus)

Abstract

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.)

Original languageEnglish (US)
Pages (from-to)1987-1997
Number of pages11
JournalNew England Journal of Medicine
Volume366
Issue number21
DOIs
StatePublished - May 24 2012

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Urodynamics
Stress Urinary Incontinence
National Institute of Diabetes and Digestive and Kidney Diseases (U.S.)
National Institute of Child Health and Human Development (U.S.)
Overactive Urinary Bladder
Patient Satisfaction
Exercise Test
Quality of Life
Confidence Intervals
Equipment and Supplies
Therapeutics

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Nager, C. W., Brubaker, L., Litman, H. J., Zyczynski, H. M., Varner, R. E., Amundsen, C., ... Gormley, E. A. (2012). A randomized trial of urodynamic testing before stress-incontinence surgery. New England Journal of Medicine, 366(21), 1987-1997. https://doi.org/10.1056/NEJMoa1113595

A randomized trial of urodynamic testing before stress-incontinence surgery. / Nager, Charles W.; Brubaker, Linda; Litman, Heather J.; Zyczynski, Halina M.; Varner, R. Edward; Amundsen, Cindy; Sirls, Larry T.; Norton, Peggy A.; Arisco, Amy M.; Chai, Toby C.; Zimmern, Philippe; Barber, Matthew D.; Dandreo, Kimberly J.; Menefee, Shawn A.; Kenton, Kimberly; Lowder, Jerry; Richter, Holly E.; Khandwala, Salil; Nygaard, Ingrid; Kraus, Stephen R.; Johnson, Harry W.; Lemack, Gary E.; Mihova, Marina; Albo, Michael E.; Mueller, Elizabeth; Sutkin, Gary; Wilson, Tracey S.; Hsu, Yvonne; Rozanski, Thomas A.; Rickey, Leslie M.; Rahn, David; Tennstedt, Sharon; Kusek, John W.; Gormley, E. Ann.

In: New England Journal of Medicine, Vol. 366, No. 21, 24.05.2012, p. 1987-1997.

Research output: Contribution to journalArticle

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 2012, 'A randomized trial of urodynamic testing before stress-incontinence surgery', New England Journal of Medicine, vol. 366, no. 21, pp. 1987-1997. https://doi.org/10.1056/NEJMoa1113595
Nager CW, Brubaker L, Litman HJ, Zyczynski HM, Varner RE, Amundsen C et al. A randomized trial of urodynamic testing before stress-incontinence surgery. New England Journal of Medicine. 2012 May 24;366(21):1987-1997. https://doi.org/10.1056/NEJMoa1113595
Nager, Charles W. ; Brubaker, Linda ; Litman, Heather J. ; Zyczynski, Halina M. ; Varner, R. Edward ; Amundsen, Cindy ; Sirls, Larry T. ; Norton, Peggy A. ; Arisco, Amy M. ; Chai, Toby C. ; Zimmern, Philippe ; Barber, Matthew D. ; Dandreo, Kimberly J. ; Menefee, Shawn A. ; Kenton, Kimberly ; Lowder, Jerry ; Richter, Holly E. ; Khandwala, Salil ; Nygaard, Ingrid ; Kraus, Stephen R. ; Johnson, Harry W. ; Lemack, Gary E. ; Mihova, Marina ; Albo, Michael E. ; Mueller, Elizabeth ; Sutkin, Gary ; Wilson, Tracey S. ; Hsu, Yvonne ; Rozanski, Thomas A. ; Rickey, Leslie M. ; Rahn, David ; Tennstedt, Sharon ; Kusek, John W. ; Gormley, E. Ann. / A randomized trial of urodynamic testing before stress-incontinence surgery. In: New England Journal of Medicine. 2012 ; Vol. 366, No. 21. pp. 1987-1997.
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abstract = "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.)",
author = "Nager, {Charles W.} and Linda Brubaker and Litman, {Heather J.} and Zyczynski, {Halina M.} and Varner, {R. Edward} and Cindy Amundsen and Sirls, {Larry T.} and Norton, {Peggy A.} and Arisco, {Amy M.} and Chai, {Toby C.} and Philippe Zimmern and Barber, {Matthew D.} and Dandreo, {Kimberly J.} and Menefee, {Shawn A.} and Kimberly Kenton and Jerry Lowder and Richter, {Holly E.} and Salil Khandwala and Ingrid Nygaard and Kraus, {Stephen R.} and Johnson, {Harry W.} and Lemack, {Gary E.} and Marina Mihova and Albo, {Michael E.} and Elizabeth Mueller and Gary Sutkin and Wilson, {Tracey S.} and Yvonne Hsu and Rozanski, {Thomas A.} and Rickey, {Leslie M.} and David Rahn and Sharon Tennstedt and Kusek, {John W.} and Gormley, {E. Ann}",
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T1 - A randomized trial of urodynamic testing before stress-incontinence surgery

AU - Nager, Charles W.

AU - Brubaker, Linda

AU - Litman, Heather J.

AU - Zyczynski, Halina M.

AU - Varner, R. Edward

AU - Amundsen, Cindy

AU - Sirls, Larry T.

AU - Norton, Peggy A.

AU - Arisco, Amy M.

AU - Chai, Toby C.

AU - Zimmern, Philippe

AU - Barber, Matthew D.

AU - Dandreo, Kimberly J.

AU - Menefee, Shawn A.

AU - Kenton, Kimberly

AU - Lowder, Jerry

AU - Richter, Holly E.

AU - Khandwala, Salil

AU - Nygaard, Ingrid

AU - Kraus, Stephen R.

AU - Johnson, Harry W.

AU - Lemack, Gary E.

AU - Mihova, Marina

AU - Albo, Michael E.

AU - Mueller, Elizabeth

AU - Sutkin, Gary

AU - Wilson, Tracey S.

AU - Hsu, Yvonne

AU - Rozanski, Thomas A.

AU - Rickey, Leslie M.

AU - Rahn, David

AU - Tennstedt, Sharon

AU - Kusek, John W.

AU - Gormley, E. Ann

PY - 2012/5/24

Y1 - 2012/5/24

N2 - 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.)

AB - 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.)

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