Randomised Controlled Trial Comparing Tension-Free Vaginal Tape (TVT), Pelvicol & Autologous Slings for Stress Urinary Incontinence(SUI)
Phase 3
Completed
- Conditions
- Stress Urinary Incontinence
- Interventions
- Procedure: Autologous fascial slingProcedure: TVTProcedure: Pelvicol
- Registration Number
- NCT01057550
- Lead Sponsor
- Abertawe Bro Morgannwg University NHS Trust
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 201
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Autologous Fascial Sling Autologous fascial sling Retropubic, bottom up autologous sling TVT TVT Standard retropubic TVT Pelvicol Pelvicol Retropubic mid urethral sling made from Pelvicol
- Primary Outcome Measures
Name Time Method success rate at improving symptom of stress urinary incontinence 1 year
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
ABM University Hospital NHS trust
🇬🇧Swansea, Wales, United Kingdom