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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:
Collaborator:
C. R. Bard
Information provided by:
Abertawe Bro Morgannwg University NHS Trust
ClinicalTrials.gov Identifier:
NCT01057550
First received: January 26, 2010
Last updated: NA
Last verified: March 2004
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • completely dry rates [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • quality of life scores [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • intra & post-operative complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • re-operation rates [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • hospital stay [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • operative time [ Time Frame: hours ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Karen Guerrero, ABM University Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT01057550     History of Changes
Other Study ID Numbers: 2000.117
Study First Received: January 26, 2010
Last Updated: January 26, 2010
Health Authority: United Kingdom: National Health Service

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

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013