Phase 4
N=132
Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence
Urinary Bladder, Overactive
Bottom Line
View on ClinicalTrials.gov: NCT01194999 ↗Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcome: Primary: Change in OAB Symptoms Post Pubovaginal Sling Operation — 63; 21; 4 participants — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pubovaginal sling procedure (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Barrie Urology Associates
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in OAB Symptoms Post Pubovaginal Sling Operation |
63; 21; 4 | 0.001 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01194999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.