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

Study 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.

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

Conditions
-----------------
Urinary Bladder, Overactive

Intervention / Treatment
-----------------
* Device: Pubovaginal sling procedure


Participation Criteria
=================
Eligibility 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.
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pubovaginal sling procedure<br>Patients undergoing pubovaginal slings for stress urinary incontinence. | Device: Pubovaginal sling procedure<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in OAB Symptoms Post Pubovaginal Sling Operation | Measured through the administration of five overactive bladder questionnaires. Difference from baseline to follow-up evaluated using the Wilcoxon Signed Rank Test. | Baseline to final follow-up. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OAB, Urinary Bladder, Overactive, Overactive Bladder Syndrome, VESIcare, Urgency, Nocturia, Frequency, Urge Urinary Incontinence, UUI, Pubovaginal Sling, PVS, Incontinence