Randomised Controlled Trial Comparing Tension-Free Vaginal Tape (TVT), Pelvicol & Autologous Slings for Stress Urinary Incontinence(SUI)

Phase 3

Completed

• Conditions: Stress Urinary Incontinence

• 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

Study Timeline

• Study Start: 2001-10
• Status Verified: 2004-03
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Study First Submitted: 2010-01-26
• Study First Submitted QC: 2010-01-26
• Last Update Submitted: 2010-01-26
• Study First Posted: 2010-01-27
• Last Update Posted: 2010-01-27

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

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