Skip to content

Urodynamic Studies Prior to Surgery for Stress Urinary Incontinence

Complex Urodynamic Testing: Who Requires it? A Retrospective Review

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03107130
Enrollment
266
Registered
2017-04-11
Start date
2017-02-28
Completion date
2018-09-07
Last updated
2018-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urodynamic Studies

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.

Interventions

None listed

Sponsors

TriHealth Inc.
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Age \< 18 years old * Concomitant surgery for anterior or apical pelvic organ prolapse

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients who meet VALUE trial criteriaWithin 15 months to the initial presentationA 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026