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

Phase 4

Completed

• Conditions: Urinary Bladder, Overactive
• Interventions: Device: Pubovaginal sling procedure

• Registration Number: NCT01194999
• Lead Sponsor: Barrie Urology Associates

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-02
• Study First Submitted QC: 2010-09-02
• Study First Posted: 2010-09-03
• Study Start: 2010-10
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-08
• Results First Submitted: 2012-08-21
• Results First Submitted QC: 2012-08-21
• Last Update Submitted: 2012-08-21
• Results First Posted: 2012-09-20
• Last Update Posted: 2012-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 132

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pubovaginal sling procedure	Pubovaginal sling procedure	Patients undergoing pubovaginal slings for stress urinary incontinence.

Primary Outcome Measures

Name	Time	Method
Change in OAB Symptoms Post Pubovaginal Sling Operation	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.

Trial Locations

Locations (1)

Barrie Urology Associates - The Male/Female Health and Research Centre; 🇨🇦 Barrie, Ontario, Canada