Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence
Primary Purpose
Urinary Bladder, Overactive
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Pubovaginal sling procedure
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring OAB, Urinary Bladder, Overactive, Overactive Bladder Syndrome, VESIcare, Urgency, Nocturia, Frequency, Urge Urinary Incontinence, UUI, Pubovaginal Sling, PVS, Incontinence
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.
Sites / Locations
- Barrie Urology Associates - The Male/Female Health and Research Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pubovaginal sling procedure
Arm Description
Patients undergoing pubovaginal slings for stress urinary incontinence.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01194999
First Posted
September 2, 2010
Last Updated
August 21, 2012
Sponsor
Barrie Urology Associates
Collaborators
Astellas Pharma Canada, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01194999
Brief Title
Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence
Official Title
Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barrie Urology Associates
Collaborators
Astellas Pharma Canada, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive
Keywords
OAB, Urinary Bladder, Overactive, Overactive Bladder Syndrome, VESIcare, Urgency, Nocturia, Frequency, Urge Urinary Incontinence, UUI, Pubovaginal Sling, PVS, Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pubovaginal sling procedure
Arm Type
Experimental
Arm Description
Patients undergoing pubovaginal slings for stress urinary incontinence.
Intervention Type
Device
Intervention Name(s)
Pubovaginal sling procedure
Intervention Description
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 Outcome Measure Information:
Title
Change in OAB Symptoms Post Pubovaginal Sling Operation
Description
Measured through the administration of five overactive bladder questionnaires. Difference from baseline to follow-up evaluated using the Wilcoxon Signed Rank Test.
Time Frame
Baseline to final follow-up.
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph A Zadra, MD CM FRCSC
Organizational Affiliation
Barrie Urology Associates - The Male/Female Health and Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrie Urology Associates - The Male/Female Health and Research Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
19002645
Citation
Toledo LG, Korkes F, Romero FR, Fernandes RC, Oliveira C, Perez MD. Bladder outlet obstruction after pubovaginal fascial sling. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Feb;20(2):201-5. doi: 10.1007/s00192-008-0759-8. Epub 2008 Nov 12.
Results Reference
background
PubMed Identifier
18520757
Citation
Koch YK, Zimmern P. A critical overview of the evidence base for the contemporary surgical management of stress incontinence. Curr Opin Urol. 2008 Jul;18(4):370-6. doi: 10.1097/MOU.0b013e3282fdf8d5.
Results Reference
background
PubMed Identifier
17574730
Citation
Chapple CR, Fianu-Jonsson A, Indig M, Khullar V, Rosa J, Scarpa RM, Mistry A, Wright DM, Bolodeoku J; STAR study group. Treatment outcomes in the STAR study: a subanalysis of solifenacin 5 mg and tolterodine ER 4 mg. Eur Urol. 2007 Oct;52(4):1195-203. doi: 10.1016/j.eururo.2007.05.027. Epub 2007 Jun 6.
Results Reference
background
PubMed Identifier
20339833
Citation
Toglia MR, Ostergard DR, Appell RA, Andoh M, Fakhoury A, Hussain IF. Solifenacin for overactive bladder: secondary analysis of data from VENUS based on baseline continence status. Int Urogynecol J. 2010 Jul;21(7):847-54. doi: 10.1007/s00192-010-1120-6. Epub 2010 Mar 26.
Results Reference
background
PubMed Identifier
18995887
Citation
Karram MM, Toglia MR, Serels SR, Andoh M, Fakhoury A, Forero-Schwanhaeuser S. Treatment with solifenacin increases warning time and improves symptoms of overactive bladder: results from VENUS, a randomized, double-blind, placebo-controlled trial. Urology. 2009 Jan;73(1):14-8. doi: 10.1016/j.urology.2008.08.485. Epub 2008 Nov 8.
Results Reference
background
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Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence
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