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

Abertawe Bro Morgannwg University NHS Trust201 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

201

Conditions

Stress Urinary Incontinence

Interventions

Autologous fascial slingPROCEDURE

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

TVTPROCEDURE

Standard TVT as described by Ulmsten 1996

PelvicolPROCEDURE

retropubic mid urethral sling made from Pelvicol

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

ABM University Hospital NHS trust

Swansea, Wales, United Kingdom

Outcomes

Primary Outcomes

success rate at improving symptom of stress urinary incontinence

Time frame: 1 year

Secondary Outcomes

completely dry rates

Time frame: 1 year

quality of life scores

Time frame: 1 year

intra & post-operative complications

Time frame: 1 year

re-operation rates

Time frame: 1 year

hospital stay

Time frame: 5 days

operative time

Time frame: hours

Data from ClinicalTrials.gov

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