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

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ClinicalTrials.gov Identifier: NCT01194999
Recruitment Status : Completed
First Posted : September 3, 2010
Results First Posted : September 20, 2012
Last Update Posted : September 20, 2012
Sponsor:
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Dr. Joseph Zadra, Barrie Urology Associates

Study Description
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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.


Condition or disease Intervention/treatment Phase
Urinary Bladder, Overactive Device: Pubovaginal sling procedure Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence
Study Start Date : October 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01194999


Locations
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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
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Principal Investigator: Joseph A Zadra, MD CM FRCSC Barrie Urology Associates - The Male/Female Health and Research Centre
More Information
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Publications:

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Responsible Party: Dr. Joseph Zadra, Chief of Urology, RVH, Barrie Urology Associates
ClinicalTrials.gov Identifier: NCT01194999    
Other Study ID Numbers: ARC-2010-04
First Posted: September 3, 2010    Key Record Dates
Results First Posted: September 20, 2012
Last Update Posted: September 20, 2012
Last Verified: August 2012
Keywords provided by Dr. Joseph Zadra, 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:
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Urinary Bladder, Overactive
Urinary Incontinence, Stress
Urinary Bladder Diseases
Urologic Diseases
 Lower Urinary Tract Symptoms
Urological Manifestations
Urinary Incontinence
Urination Disorders