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Clinical Trials/NCT01194999
NCT01194999
Completed
Phase 4

Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence

Barrie Urology Associates1 site in 1 country132 target enrollmentOctober 2010

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Urinary Bladder, Overactive
Sponsor
Barrie Urology Associates
Enrollment
132
Locations
1
Primary Endpoint
Change in OAB Symptoms Post Pubovaginal Sling Operation
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

Pubovaginal sling (PVS) procedures are designed to curtail bladder leakage brought about by strenuous events such as child birth. A common purported side effect of PVS is urgency, the feeling of a compelling need to void with little warning. Other overactive bladder (OAB) adverse effects that some claim to develop post-op include further leakage (incontinence), frequency and nocturia (night time leakage). Anecdotal evidence from our clinic however, suggests that such de novo OAB symptoms are rarely induced by PVS, and may in fact be alleviated by said procedure. It is our aim to investigate this relationship in our clinic.

As a prospective member of this study, you will be asked to complete five surveys. The first survey will be administered prior to your pubovaginal sling. This will be used to establish your baseline experience of OAB. Over the course of the next year, you will be asked to complete the four remaining surveys at regularly scheduled check-ups.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
June 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Barrie Urology Associates
Responsible Party
Principal Investigator
Principal Investigator

Dr. Joseph Zadra

Chief of Urology, RVH

Barrie Urology Associates

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in OAB Symptoms Post Pubovaginal Sling Operation

Time Frame: Baseline to final follow-up.

Measured through the administration of five overactive bladder questionnaires. Difference from baseline to follow-up evaluated using the Wilcoxon Signed Rank Test.

Study Sites (1)

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