Status:
COMPLETED
Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Alberta Health services
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Stress urinary incontinence (SUI) is a health concern for many women. The transvaginal tape (TVT) surgery has become a common procedure to address the problem. Another surgery is now available, trans-...
Detailed Description
This study is a randomized trial in which women with stress incontinence will be allocated to receive either TOT or TVT procedures. Women who elect surgical management of their type II stress incontin...
Eligibility Criteria
Inclusion
- Women with type II stress incontinence, defined as leaking with increased abdominal pressure
- Are eligible for both types of surgery
Exclusion
- Have vaginal prolapse requiring surgical repair
- Have had previous incontinence surgery
- Have overactive bladder or incontinence is caused only by bladder overflow
- Intend to have further children
- Have Alzheimer's or Parkinson's disease, progressive neurological disease such as multiple sclerosis, or are immunocompromised
- Are unable to understand English
- Will be unavailable for follow-up
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT00234754
Start Date
September 1 2005
End Date
October 1 2013
Last Update
August 31 2016
Active Locations (1)
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1
Calgary Health Region
Calgary, Alberta, Canada, T2N 2T9