Back to resultsRandomised Controlled Trial Comparing Tension-Free Vaginal Tape (TVT), Pelvicol & Autologous Slings for Stress Urinary Incontinence(SUI)
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Autologous fascial sling
TVT
Pelvicol
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Stress urinary Incontinence, autologous slings, slings, tvt, grafts, surgery
Eligibility Criteria
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
Sites / Locations
- ABM University Hospital NHS trust
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Autologous Fascial Sling
TVT
Pelvicol
Arm Description
Retropubic, bottom up autologous sling
Standard retropubic TVT
Retropubic mid urethral sling made from Pelvicol
Outcomes
Primary Outcome Measures
success rate at improving symptom of stress urinary incontinence
Secondary Outcome Measures
completely dry rates
quality of life scores
intra & post-operative complications
re-operation rates
hospital stay
operative time
Full Information
NCT ID
NCT01057550
First Posted
January 26, 2010
Last Updated
January 26, 2010
Sponsor
Abertawe Bro Morgannwg University NHS Trust
Collaborators
C. R. Bard
1. Study Identification
Unique Protocol Identification Number
NCT01057550
Brief Title
Randomised Controlled Trial Comparing Tension-Free Vaginal Tape (TVT), Pelvicol & Autologous Slings for Stress Urinary Incontinence(SUI)
Official Title
A Randomised Controlled Trial Comparing TVT, Pelvicol and Autologous Fascial Slings for the Treatment of Stress Urinary Incontinence in Women
Study Type
Interventional
2. Study Status
Record Verification Date
March 2004
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abertawe Bro Morgannwg University NHS Trust
Collaborators
C. R. Bard
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Stress urinary Incontinence, autologous slings, slings, tvt, grafts, surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Autologous Fascial Sling
Arm Type
Active Comparator
Arm Description
Retropubic, bottom up autologous sling
Arm Title
TVT
Arm Type
Active Comparator
Arm Description
Standard retropubic TVT
Arm Title
Pelvicol
Arm Type
Active Comparator
Arm Description
Retropubic mid urethral sling made from Pelvicol
Intervention Type
Procedure
Intervention Name(s)
Autologous fascial sling
Intervention Description
Retropubic bottom up mid urethral sling made using autologous rectus sheath fascia
Intervention Type
Procedure
Intervention Name(s)
TVT
Intervention Description
Standard TVT as described by Ulmsten 1996
Intervention Type
Procedure
Intervention Name(s)
Pelvicol
Intervention Description
retropubic mid urethral sling made from Pelvicol
Primary Outcome Measure Information:
Title
success rate at improving symptom of stress urinary incontinence
Time Frame
1 year
Secondary Outcome Measure Information:
Title
completely dry rates
Time Frame
1 year
Title
quality of life scores
Time Frame
1 year
Title
intra & post-operative complications
Time Frame
1 year
Title
re-operation rates
Time Frame
1 year
Title
hospital stay
Time Frame
5 days
Title
operative time
Time Frame
hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malcolm G Lucas
Organizational Affiliation
ABM University Hospital NHS trust
Official's Role
Study Chair
Facility Information:
Facility Name
ABM University Hospital NHS trust
City
Swansea
State/Province
Wales
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
20939862
Citation
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.
Results Reference
result
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Randomised Controlled Trial Comparing Tension-Free Vaginal Tape (TVT), Pelvicol & Autologous Slings for Stress Urinary Incontinence(SUI)
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