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

January 26, 2010 updated by: Abertawe Bro Morgannwg University NHS Trust

A Randomised Controlled Trial Comparing TVT, Pelvicol and Autologous Fascial Slings for the Treatment of Stress Urinary Incontinence in Women

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Wales
      • Swansea, Wales, United Kingdom, SA2 8QA
        • ABM University Hospital NHS trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Autologous Fascial Sling
Retropubic, bottom up autologous sling
Procedure: Autologous fascial sling
Retropubic bottom up mid urethral sling made using autologous rectus sheath fascia
ACTIVE_COMPARATOR: TVT
Standard retropubic TVT
Procedure: TVT
Standard TVT as described by Ulmsten 1996
ACTIVE_COMPARATOR: Pelvicol
Retropubic mid urethral sling made from Pelvicol
Procedure: Pelvicol
retropubic mid urethral sling made from Pelvicol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
success rate at improving symptom of stress urinary incontinence
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
completely dry rates
Time Frame: 1 year
1 year
quality of life scores
Time Frame: 1 year
1 year
intra & post-operative complications
Time Frame: 1 year
1 year
re-operation rates
Time Frame: 1 year
1 year
hospital stay
Time Frame: 5 days
5 days
operative time
Time Frame: hours
hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abertawe Bro Morgannwg University NHS Trust

Collaborators

C. R. Bard

Investigators

  • Study Chair: Malcolm G Lucas, ABM University Hospital NHS trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • a randomised control trial comparing TVT, Pelvicol and autologous fascial slings for the treatment of stress urinary incontinence in women. BJU Int 2008:101:supp 5;p27

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Primary Completion (ACTUAL)

November 1, 2006

Study Completion (ACTUAL)

November 1, 2006

Study Registration Dates

First Submitted

January 26, 2010

First Submitted That Met QC Criteria

January 26, 2010

First Posted (ESTIMATE)

January 27, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 27, 2010

Last Update Submitted That Met QC Criteria

January 26, 2010

Last Verified

March 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000.117

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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