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

Abertawe Bro Morgannwg University NHS Trust

Status and phase: Completed; Phase 3

Conditions: Stress Urinary Incontinence

Treatments: Procedure: TVT; Procedure: Autologous fascial sling; Procedure: Pelvicol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01057550

2000.117

Details and patient eligibility

About

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.

Enrollment: 201 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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201 participants in 3 patient groups

Autologous Fascial Sling

Active Comparator group

Description:

Retropubic, bottom up autologous sling

Treatment:

Procedure: Autologous fascial sling

TVT

Active Comparator group

Description:

Standard retropubic TVT

Treatment:

Procedure: TVT

Pelvicol

Active Comparator group

Description:

Retropubic mid urethral sling made from Pelvicol

Treatment:

Procedure: Pelvicol