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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2006-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Stress Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Autologous Fascial Sling

Retropubic, bottom up autologous sling

Group Type ACTIVE_COMPARATOR

Autologous fascial sling

Intervention Type PROCEDURE

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

TVT

Standard retropubic TVT

Group Type ACTIVE_COMPARATOR

TVT

Intervention Type PROCEDURE

Standard TVT as described by Ulmsten 1996

Pelvicol

Retropubic mid urethral sling made from Pelvicol

Group Type ACTIVE_COMPARATOR

Pelvicol

Intervention Type PROCEDURE

retropubic mid urethral sling made from Pelvicol

Interventions

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Autologous fascial sling

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

Intervention Type PROCEDURE

TVT

Standard TVT as described by Ulmsten 1996

Intervention Type PROCEDURE

Pelvicol

retropubic mid urethral sling made from Pelvicol

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes