Urodynamic Studies Prior to Surgery for Stress Urinary Incontinence
Complex Urodynamic Testing: Who Requires it? A Retrospective Review
1 other identifier
observational
266
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2017
CompletedFirst Submitted
Initial submission to the registry
March 14, 2017
CompletedFirst Posted
Study publicly available on registry
April 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2018
CompletedOctober 25, 2018
October 1, 2018
11 months
March 14, 2017
October 24, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
SUI Surgery Patients in 2015
All women 18 years of age or older, who underwent surgery for SUI between January 2015 and December 2015
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- Age \< 18 years old
- Concomitant surgery for anterior or apical pelvic organ prolapse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TriHealth Inc.lead
Study Sites (1)
Cincinnati Urogynecology Associates
Cincinnati, Ohio, 45220, United States
Related Publications (1)
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.
PMID: 22551104BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Rachel Pauls, MD
TriHealth - Cincinnati Urogynecology Associates
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2017
First Posted
April 11, 2017
Study Start
February 28, 2017
Primary Completion
January 25, 2018
Study Completion
September 7, 2018
Last Updated
October 25, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share