NCT01057550CompletedPhase 3
A Randomised Controlled Trial Comparing TVT, Pelvicol and Autologous Fascial Slings for the Treatment of Stress Urinary Incontinence in Women
Abertawe Bro Morgannwg University NHS Trust2 sites in 1 country201 target enrollmentStarted: October 1, 2001Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 201
- Locations
- 2
- Primary Endpoint
- success rate at improving symptom of stress urinary incontinence
Study Overview
Brief Summary
The purpose of this trial was to discover which type of operation for stress urinary incontinence in women offered better results: autologous slings, TVT or Pelvicol slings.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Women requiring surgery for SUI following failed conservative treatment
Exclusion Criteria
- •Under 18 years of age
- •Previous surgery for SUI
- •Evidence of neurological disease
- •Pelvic Organ Prolapse (POP) greater than Grade 2
- •Women with any evidence of Detrusor Overactivity or bladder hypocompliance on urodynamic assessment
Outcomes
Primary Outcomes
success rate at improving symptom of stress urinary incontinence
Time Frame: 1 year
Secondary Outcomes
- completely dry rates(1 year)
- quality of life scores(1 year)
- intra & post-operative complications(1 year)
- re-operation rates(1 year)
- hospital stay(5 days)
- operative time(hours)
Investigators
Study Sites (2)
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