Clinical Trials Logo
  1. Home
  2. Stress Urinary Incontinence
  3. NCT01057550
  4. Details
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
See also
  Status Clinical Trial Phase
Recruiting NCT04829357 - Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
Completed NCT05493735 - Lidocaine for Pessary Check Pain Reduction Phase 3
Completed NCT04512053 - A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence Phase 2
Active, not recruiting NCT06224335 - Measurement of Intravaginal and Intra-abdominal Pressure and Pad Test During Sports Activities (SPORTVAGPRES)
Recruiting NCT05304312 - The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women N/A
Not yet recruiting NCT05527665 - Sexual Fonction and Discomfort in Women After Midurethral Sling Surgery, Using PPSSQ
Not yet recruiting NCT04558762 - Ten Years Follow-up After Insertion of a MUS (Mid Urethral Sling) Due to Stress Urinary Incontinence
Withdrawn NCT02524366 - A Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement N/A
Completed NCT01924728 - Efficacy of Magnetic Stimulation for Stress Urinary Incontinence N/A
Completed NCT01676662 - Solace European Confirmatory Trial N/A
Unknown status NCT01455779 - Lyrette: Renewing Continence Objective and Subjective Efficacy Study N/A
Terminated NCT01029106 - Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI) N/A
Completed NCT01770691 - Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence N/A
Withdrawn NCT00573703 - Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence Phase 4
Completed NCT01123096 - Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence? N/A
Completed NCT00234754 - Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women N/A
Completed NCT00441454 - Retropubic vs. Transobturator Tension-free Vaginal Tape N/A
Completed NCT03985345 - Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence. N/A
Active, not recruiting NCT03671694 - Laser Vaginal Treatment for SUI N/A
Completed NCT04097288 - Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects Phase 1