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

January 26, 2010
January 26, 2010
October 2001
November 2006   (final data collection date for primary outcome measure)
success rate at improving symptom of stress urinary incontinence [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Randomised Controlled Trial Comparing Tension-Free Vaginal Tape (TVT), Pelvicol & Autologous Slings for Stress Urinary Incontinence(SUI)
A Randomised Controlled Trial Comparing TVT, Pelvicol and Autologous Fascial Slings for the Treatment of Stress Urinary Incontinence in Women

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Stress Urinary Incontinence
  • Procedure: Autologous fascial sling
    Retropubic bottom up mid urethral sling made using autologous rectus sheath fascia
  • Procedure: TVT
    Standard TVT as described by Ulmsten 1996
  • Procedure: Pelvicol
    retropubic mid urethral sling made from Pelvicol
  • Active Comparator: Autologous Fascial Sling
    Retropubic, bottom up autologous sling
    Intervention: Procedure: Autologous fascial sling
  • Active Comparator: TVT
    Standard retropubic TVT
    Intervention: Procedure: TVT
  • Active Comparator: Pelvicol
    Retropubic mid urethral sling made from Pelvicol
    Intervention: Procedure: Pelvicol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
201
November 2006
November 2006   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01057550
2000.117
Yes
Dr Karen Guerrero, ABM University Hospital NHS Trust
Abertawe Bro Morgannwg University NHS Trust
C. R. Bard
Study Chair: Malcolm G Lucas ABM University Hospital NHS trust
Abertawe Bro Morgannwg University NHS Trust
March 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP