Skip to main content
OpenTrials
Completed

NCT Number: NCT01194999

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Bladder, Overactive Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Nocturia Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Barrie Urology Associates - The Male/Female Health and Research Centre

Barrie, Ontario, L4M 7G1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pubovaginal sling procedure

Device

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.

Primary outcomes

  1. Change in OAB Symptoms Post Pubovaginal Sling Operation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Barrie Urology Associates

Other

Collaborators

  • Astellas Pharma Canada, Inc.

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 3, 2010
Registry last updated
Sep 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.