NCT01194999

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Barrie Urology Associates · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Bladder, Overactive

Interventions

Type	Name	Description
DEVICE	Pubovaginal sling procedure	The procedure involves placing a band of sling material directly under the bladder neck (ie, proximal urethra) or mid-urethra, which acts as a physical support to prevent bladder neck and urethral descent during physical activity. The sling also may augment the resting urethral closure pressure with increases in intra-abdominal pressure.

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-09-03
• Last updated: 2012-09-20
• Results posted: 2012-09-20

Locations

1 site across 1 country: Canada