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

Barrie Urology Associates

Status and phase: Completed; Phase 4

Conditions: Urinary Bladder, Overactive

Treatments: Device: Pubovaginal sling procedure

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01194999

ARC-2010-04

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria.

• Post-pubovaginal sling patient.
• Complete agreement and signing of Informed Consent Form.

Exclusion Criteria.

• Currently taking antimuscarinics or α1 blockers.
• Patients with urinary retention, dependent on dialysis, gastroparesis or narrow angle glaucoma.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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132 participants in 1 patient group

Pubovaginal sling procedure

Experimental group

Description:

Patients undergoing pubovaginal slings for stress urinary incontinence.

Treatment:

Device: Pubovaginal sling procedure