Randomised Controlled Trial Comparing Tension-Free Vaginal Tape (TVT), Pelvicol & Autologous Slings for Stress Urinary Incontinence(SUI)
A Randomised Controlled Trial Comparing TVT, Pelvicol and Autologous Fascial Slings for the Treatment of Stress Urinary Incontinence in Women
1 other identifier
interventional
201
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2001
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 26, 2010
CompletedFirst Posted
Study publicly available on registry
January 27, 2010
CompletedJanuary 27, 2010
March 1, 2004
5.1 years
January 26, 2010
January 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
success rate at improving symptom of stress urinary incontinence
1 year
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (3)
Autologous Fascial Sling
ACTIVE COMPARATORRetropubic, bottom up autologous sling
TVT
ACTIVE COMPARATORStandard retropubic TVT
Pelvicol
ACTIVE COMPARATORRetropubic mid urethral sling made from Pelvicol
Interventions
Retropubic bottom up mid urethral sling made using autologous rectus sheath fascia
Eligibility Criteria
You may qualify if:
- Women requiring surgery for SUI following failed conservative treatment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abertawe Bro Morgannwg University NHS Trustlead
- C. R. Bardcollaborator
Study Sites (1)
ABM University Hospital NHS trust
Swansea, Wales, SA2 8QA, United Kingdom
Related Publications (1)
Guerrero KL, Emery SJ, Wareham K, Ismail S, Watkins A, Lucas MG. A randomised controlled trial comparing TVT, Pelvicol and autologous fascial slings for the treatment of stress urinary incontinence in women. BJOG. 2010 Nov;117(12):1493-502. doi: 10.1111/j.1471-0528.2010.02696.x. Epub 2010 Sep 24.
PMID: 20939862RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Malcolm G Lucas
ABM University Hospital NHS trust
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
January 26, 2010
First Posted
January 27, 2010
Study Start
October 1, 2001
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
January 27, 2010
Record last verified: 2004-03