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

NCT01057550 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2010-01-27

No results posted yet for this study

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.

Conditions

  • Stress Urinary Incontinence

Interventions

PROCEDURE

Autologous fascial sling

Retropubic bottom up mid urethral sling made using autologous rectus sheath fascia

PROCEDURE

TVT

Standard TVT as described by Ulmsten 1996

PROCEDURE

Pelvicol

retropubic mid urethral sling made from Pelvicol

Sponsors & Collaborators

  • C. R. Bard

    collaborator INDUSTRY

  • Abertawe Bro Morgannwg University NHS Trust

    lead OTHER_GOV

Principal Investigators

  • Malcolm G Lucas · ABM University Hospital NHS trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-10-31
Primary Completion
2006-11-30
Completion
2006-11-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01057550 on ClinicalTrials.gov