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NCT01057550 Clinical Trial

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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01057550
Other study ID # 2000.117
Secondary ID
Status Completed
Phase Phase 3
First received January 26, 2010
Last updated January 26, 2010
Start date October 2001
Est. completion date November 2006

Study information
Verified date March 2004
Source Abertawe Bro Morgannwg University NHS Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 201
Est. completion date November 2006
Est. primary completion date November 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Autologous fascial sling
Retropubic bottom up mid urethral sling made using autologous rectus sheath fascia
• TVT
Standard TVT as described by Ulmsten 1996
• Pelvicol
retropubic mid urethral sling made from Pelvicol

Locations
Country Name City State
United Kingdom ABM University Hospital NHS trust Swansea Wales

Sponsors (2)
Lead Sponsor Collaborator
Abertawe Bro Morgannwg University NHS Trust C. R. Bard

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

a randomised control trial comparing TVT, Pelvicol and autologous fascial slings for the treatment of stress urinary incontinence in women. BJU Int 2008:101:supp 5;p27

Outcome
Type Measure Description Time frame Safety issue
Primary success rate at improving symptom of stress urinary incontinence 1 year No
Secondary completely dry rates 1 year No
Secondary quality of life scores 1 year No
Secondary intra & post-operative complications 1 year Yes
Secondary re-operation rates 1 year No
Secondary hospital stay 5 days No
Secondary operative time hours Yes
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