Status:
TERMINATED
Transvaginal Tape (TVT) Secur Versus TVT Randomised Controlled Trial (RCT)
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
University of Alberta
Johnson & Johnson Medical Companies
Conditions:
Urinary Incontinence, Stress
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
This randomized multi-centre trial will recruit women with stress urinary incontinence who need surgical treatment for their condition. 300 women will be allocated either to receive a TVT Secur or a s...
Eligibility Criteria
Inclusion
- Women with stress incontinence, defined as leaking with increased abdominal pressure
- Eligible for both types of surgery
Exclusion
- Women who:
- 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 :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00685217
Start Date
May 1 2008
End Date
April 1 2012
Last Update
August 31 2016
Active Locations (4)
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1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 1C5
2
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
3
Penticton Regional Hospital
Penticton, British Columbia, Canada, V2A 3G6
4
Lions Gate Hospital
Vancouver, British Columbia, Canada, V7L 2L7