Urodynamic Studies Prior to Surgery for Stress Urinary Incontinence
- Conditions
- Urodynamic Studies
- Registration Number
- NCT03107130
- Lead Sponsor
- TriHealth Inc.
- Brief Summary
This retrospective descriptive study is to determine what proportion of Cincinnati Urogynecology Associates patients who underwent surgical management for stress urinary incontinence (SUI) would qualify for a basic office exam (BOE) alone, using the inclusion and exclusion criteria of the Value of Urodynamic Evaluation (VALUE) trial, and thus could have potentially had Urodynamic studies (UDS) omitted from their preoperative workup.
- Detailed Description
Urodynamic studies (UDS) are an assessment tool used to evaluate physiologic variables during bladder filling, bladder storage, and bladder emptying. They are commonly performed as part of the routine preoperative evaluation of women with symptoms of SUI. However, UDS are costly, with payments allowed by Medicare quoted at greater than $500, time consuming, uncomfortable, and have been shown to increase the risk of urinary tract infection. But most concerning is the fact that UDS have not been shown to improve surgical outcomes.
In 2012, the Value of Urodynamic Evaluation (VALUE) trial evaluated 630 women who underwent a basic office exam (BOE) or BOE plus UDS, and concluded that for women with uncomplicated, demonstrable SUI a BOE alone was not inferior to evaluation with UDS for outcomes at 1 year. This recent publication has resulted in urogynecology practices across the country evaluating their own standard of care when it comes to preoperative evaluation of SUI.
Cincinnati Urogynecology Associates, TriHealth Inc. standard practice is to perform UDS on all patients undergoing surgery for SUI. The providers of Cincinnati Urogynecology Associates, TriHealth Inc. would be remiss if the providers did not follow this trend and evaluate their own personal practice of preoperative UDS in patients presenting with SUI.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 266
- All women 18 years of age or older
- Underwent surgery for SUI performed by a physician at Cincinnati Urogynecology Associates, TriHealth Inc. between January 2015 and December 2015
- Age < 18 years old
- Concomitant surgery for anterior or apical pelvic organ prolapse
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients who meet VALUE trial criteria Within 15 months to the initial presentation A patient meets all the inclusion criteria and doesn't meet any of exclusion criteria of the VALUE trial will be classified under the category of who meets VALUE trial criteria.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cincinnati Urogynecology Associates
🇺🇸Cincinnati, Ohio, United States