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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Dr. Joseph Zadra, Barrie Urology Associates
ClinicalTrials.gov Identifier:
NCT01194999
First received: September 2, 2010
Last updated: August 21, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Urinary Bladder, Overactive
 Device: Pubovaginal sling procedure
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Barrie Urology Associates:

Primary Outcome Measures:
  • Change in OAB Symptoms Post Pubovaginal Sling Operation [ Time Frame: Baseline to final follow-up. ] [ Designated as safety issue: No ]
    Measured through the administration of five overactive bladder questionnaires. Difference from baseline to follow-up evaluated using the Wilcoxon Signed Rank Test.


Enrollment: 132
Study Start Date: October 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pubovaginal sling procedure
Patients undergoing pubovaginal slings for stress urinary incontinence.
 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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194999

Locations
Canada, Ontario
Barrie Urology Associates - The Male/Female Health and Research Centre
Barrie, Ontario, Canada, L4M 7G1
Sponsors and Collaborators
Barrie Urology Associates
Astellas Pharma Canada, Inc.
Investigators
Principal Investigator: Joseph A Zadra, MD CM FRCSC Barrie Urology Associates - The Male/Female Health and Research Centre
  More Information

Publications:

Responsible Party: Dr. Joseph Zadra, Chief of Urology, RVH, Barrie Urology Associates
ClinicalTrials.gov Identifier: NCT01194999     History of Changes
Other Study ID Numbers: ARC-2010-04
Study First Received: September 2, 2010
Results First Received: August 21, 2012
Last Updated: August 21, 2012
Health Authority: Canada: Health Canada

Keywords provided by Barrie Urology Associates:
OAB
Urinary Bladder, Overactive
Overactive Bladder Syndrome
VESIcare
Urgency
Nocturia
 Frequency
Urge Urinary Incontinence
UUI
Pubovaginal Sling
PVS
Incontinence

Additional relevant MeSH terms:
Urinary Incontinence, Stress
Urinary Bladder, Overactive
Urinary Incontinence
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on May 23, 2013