Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2009 Nov;30(6):531-9.
doi: 10.1016/j.cct.2009.07.001. Epub 2009 Jul 25.

Design of the Value of Urodynamic Evaluation (ValUE) trial: A non-inferiority randomized trial of preoperative urodynamic investigations

Charles W Nager  1 , Linda Brubaker, Firouz Daneshgari, Heather J Litman, Kimberly J Dandreo, Larry Sirls, Gary E Lemack, Holly E Richter, Wendy Leng, Peggy Norton, Stephen R Kraus, Toby C Chai, Debuene Chang, Cindy L Amundsen, Anne M Stoddard, Sharon L Tennstedt; Urinary Incontinence Treatment Network
Collaborators, Affiliations
Randomized Controlled Trial

Design of the Value of Urodynamic Evaluation (ValUE) trial: A non-inferiority randomized trial of preoperative urodynamic investigations

Charles W Nager et al. Contemp Clin Trials. 2009 Nov.

Abstract

Background and purpose: Urodynamic studies (UDS) are routinely obtained prior to surgery for stress urinary incontinence (SUI) despite a lack of evidence that UDS information has an actual impact on outcome. The primary aim of this non-inferiority randomized clinical trial is to determine whether women with symptomatic, uncomplicated SUI who undergo only a basic office evaluation (BOE) prior to SUI surgery (No UDS arm) have non-inferior treatment outcomes compared to women who have BOE and UDS (UDS arm). Secondary aims are: 1) to determine how often physicians use preoperative UDS results to alter clinical and surgical decision-making, 2) to compare the amount of improvement in incontinence outcomes, and 3) to determine the incremental cost and utility of performing UDS compared with not performing UDS.

Methods: After an initial basic office evaluation, women planning surgery for uncomplicated SUI who consent to study participation will be randomized to receive preoperative UDS or No UDS. Treatment will be planned and performed by the surgeon utilizing all the data available to them. We will compare results from the basic office evaluation (No UDS) with results from the basic office evaluation and preoperative UDS.

Results: The primary outcome will be measured at 12 months using responses to the Urogenital Distress Inventory and the Patient Global Index-Improvement.

Conclusions: Randomized trials comparing the effects of different diagnostic alternatives on treatment outcomes pose study design challenges. A non-inferiority design is appropriate when comparing a less invasive and less expensive alternative with a standard of care approach.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Trial Design *Any approved clinical care method Investigators use in their practice.
Figure 2
Figure 2
Examples of Scenarios for Non-Inferiority Trials with Trial Conclusions
See this image and copyright information in PMC

References

    1. Diokno AC, Brock BM, Brown MB, Herzog AR. Prevalence of urinary incontinence and other urological symptoms in the noninstitutionalized elderly. J Urol. 1986 Nov;136(5):1022–1025. - PubMed
    1. Hampel C, Wienhold D, Benken N, Eggersmann C, Thuroff JW. Definition of overactive bladder and epidemiology of urinary incontinence. Urology. 1997 Dec;50(6A Suppl):4–14. discussion 5–7. - PubMed
    1. Simeonova Z, Milsom I, Kullendorff AM, Molander U, Bengtsson C. The prevalence of urinary incontinence and its influence on the quality of life in women from an urban Swedish population. Acta Obstet Gynecol Scand. 1999 Jul;78(6):546–551. - PubMed
    1. Waetjen LE, Subak LL, Shen H, et al. Stress urinary incontinence surgery in the United States. Obstet Gynecol. 2003 Apr;101(4):671–676. - PubMed
    1. Agur W, Housami F, Drake M, Abrams P. Could the National Institute for Health and Clinical Excellence guidelines on urodynamics in urinary incontinence put some women at risk of a bad outcome from stress incontinence surgery? BJU Int. 2008 Nov 18; - PubMed

Publication types