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Clinical Trials/NCT01057550
NCT01057550
Completed
Phase 3

A Randomised Controlled Trial Comparing TVT, Pelvicol and Autologous Fascial Slings for the Treatment of Stress Urinary Incontinence in Women

Abertawe Bro Morgannwg University NHS Trust1 site in 1 country201 target enrollmentOctober 2001
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ConditionsStress Urinary Incontinence

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Stress Urinary Incontinence
Sponsor
Abertawe Bro Morgannwg University NHS Trust
Enrollment
201
Locations
1
Primary Endpoint
success rate at improving symptom of stress urinary incontinence
Status
Completed
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2001
End Date
November 2006
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Abertawe Bro Morgannwg University NHS Trust

Eligibility 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

Outcomes

Primary Outcomes

success rate at improving symptom of stress urinary incontinence

Time Frame: 1 year

Secondary Outcomes

  • completely dry rates(1 year)
  • quality of life scores(1 year)
  • intra & post-operative complications(1 year)
  • re-operation rates(1 year)
  • hospital stay(5 days)
  • operative time(hours)

Study Sites (1)

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