Urodynamic Studies Prior to Surgery for Stress Urinary Incontinence

Complex Urodynamic Testing: Who Requires it? A Retrospective Review

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.

Study Overview

• Status: Completed
• Conditions: Urodynamic Studies

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.

• Study Type: Observational
• Enrollment (Actual): 266

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Cincinnati Urogynecology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All women 18 years of age or older, who under went surgery for SUI performed by a physician at Cincinnati Urogynecology Associates, TriHealth Inc. between January 2015 and December 2015

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
SUI Surgery Patients in 2015; All women 18 years of age or older, who underwent surgery for SUI between January 2015 and December 2015

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who meet VALUE trial criteria	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.	Within 15 months to the initial presentation

Collaborators and Investigators

• Sponsor: TriHealth Inc.

Publications and helpful links

General Publications

• 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; Urinary Incontinence Treatment Network. A randomized trial of urodynamic testing before stress-incontinence surgery. N Engl J Med. 2012 May 24;366(21):1987-97. doi: 10.1056/NEJMoa1113595. Epub 2012 May 2.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2017
• Primary Completion (Actual): January 25, 2018
• Study Completion (Actual): September 7, 2018

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (Actual): April 11, 2017

Study Record Updates

• Last Update Posted (Actual): October 25, 2018
• Last Update Submitted That Met QC Criteria: October 24, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 17-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No