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:


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
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, see Learn About Clinical Studies.

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 July 22, 2014