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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01057550
First Posted: January 27, 2010
Last Update Posted: January 27, 2010
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.
Collaborator:
C. R. Bard
Information provided by:
Abertawe Bro Morgannwg University NHS Trust
  Purpose
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 Intervention Phase
Stress Urinary Incontinence Procedure: Autologous fascial sling Procedure: TVT Procedure: Pelvicol Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Abertawe Bro Morgannwg University NHS Trust:

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

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

Enrollment: 201
Study Start Date: October 2001
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01057550


Locations
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
Investigators
Study Chair: Malcolm G Lucas ABM University Hospital NHS trust
  More Information

Publications:
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

Responsible Party: Dr Karen Guerrero, ABM University Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT01057550     History of Changes
Other Study ID Numbers: 2000.117
First Submitted: January 26, 2010
First Posted: January 27, 2010
Last Update Posted: January 27, 2010
Last Verified: March 2004

Keywords provided by Abertawe Bro Morgannwg University NHS Trust:
Stress urinary Incontinence
autologous slings
slings
tvt
grafts
surgery

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders