COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01057550
Recruitment Status : Completed
First Posted : January 27, 2010
Last Update Posted : January 27, 2010
C. R. Bard
Information provided by:
Abertawe Bro Morgannwg University NHS Trust

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.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Procedure: Autologous fascial sling Procedure: TVT Procedure: Pelvicol Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial Comparing TVT, Pelvicol and Autologous Fascial Slings for the Treatment of Stress Urinary Incontinence in Women
Study Start Date : October 2001
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Autologous Fascial Sling
Retropubic, bottom up autologous sling
Procedure: Autologous fascial sling
Retropubic bottom up mid urethral sling made using autologous rectus sheath fascia

Active Comparator: TVT
Standard retropubic TVT
Procedure: TVT
Standard TVT as described by Ulmsten 1996

Active Comparator: Pelvicol
Retropubic mid urethral sling made from Pelvicol
Procedure: Pelvicol
retropubic mid urethral sling made from Pelvicol

Primary Outcome Measures :
  1. success rate at improving symptom of stress urinary incontinence [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. completely dry rates [ Time Frame: 1 year ]
  2. quality of life scores [ Time Frame: 1 year ]
  3. intra & post-operative complications [ Time Frame: 1 year ]
  4. re-operation rates [ Time Frame: 1 year ]
  5. hospital stay [ Time Frame: 5 days ]
  6. operative time [ Time Frame: hours ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01057550

Layout table for location information
United Kingdom
ABM University Hospital NHS trust
Swansea, Wales, United Kingdom, SA2 8QA
Sponsors and Collaborators
Abertawe Bro Morgannwg University NHS Trust
C. R. Bard
Layout table for investigator information
Study Chair: Malcolm G Lucas ABM University Hospital NHS trust
Publications of Results:
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

Layout table for additonal information
Responsible Party: Dr Karen Guerrero, ABM University Hospital NHS Trust Identifier: NCT01057550    
Other Study ID Numbers: 2000.117
First Posted: January 27, 2010    Key Record Dates
Last Update Posted: January 27, 2010
Last Verified: March 2004
Keywords provided by Abertawe Bro Morgannwg University NHS Trust:
Stress urinary Incontinence
autologous slings
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders