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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01057550

Enrollment

201

Registered

2010-01-27

Start date

2001-10-31

Completion date

2006-11-30

Last updated

2010-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence

Keywords

Stress urinary Incontinence, autologous slings, slings, tvt, grafts, surgery

Brief 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.

Interventions

PROCEDUREAutologous fascial sling

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

PROCEDURETVT

Standard TVT as described by Ulmsten 1996

PROCEDUREPelvicol

retropubic mid urethral sling made from Pelvicol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
success rate at improving symptom of stress urinary incontinence	1 year

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026