Comparison of the Result of TVT Performed at the Time of Prolapse Surgery or 3 Months After

This study has been completed.
Sponsor:
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT00308009
First received: March 27, 2006
Last updated: January 4, 2008
Last verified: November 2007

March 27, 2006
January 4, 2008
February 2002
September 2007   (final data collection date for primary outcome measure)
Any or no leakage of urine when coughing [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Any or no leakage of urine when coughing
Complete list of historical versions of study NCT00308009 on ClinicalTrials.gov Archive Site
  • The cure of urinary stress incontinence (USI) by only prolapse surgery [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Result of prolapse surgery in two intervention strategies in women suffering from both genital prolapse and USI [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • The cure of urinary stress incontinence (USI) by only prolapse surgery
  • Result of prolapse surgery in two intervention strategies in women suffering from both genital prolapse and USI
Not Provided
Not Provided
 
Comparison of the Result of TVT Performed at the Time of Prolapse Surgery or 3 Months After
Multicenter Prospective Randomized Trial Comparing to Strategies When Incontinence Surgery is Needed in Addition to Prolapse Surgery

It is unknown whether it is best to do the TVT( procedure for urinary stress incontinence in women) at the time of prolapse surgery or at a later date. Women with both conditions were randomized to both procedures together or the TVT 3 months after the prolapse surgery. Any or no leakage when couching was the main end-point, evaluated 1 year after the last surgery

All women were evaluated by the POP-Q (pelvic Organ Prolapse Quantification) prior to surgery and 1 year after.

Examination for urinary leakage was done prior to surgery and 1 year after. Group 2 was also examined after prolapse surgery to see if TVT was still needed.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pelvic Organ Prolapse
  • Urinary Stress Incontinence
  • Procedure: Vaginal Repair for prolapse, TVT procedure
    1. TVT at the time of Vaginal Repair
    2. TVT 3 months after Vaginal Repair
  • Procedure: TVT and Prolapse surgery
    1. TVT at the time of Prolapse surgery
    2. TVT 3 months after Prolapse Surgery
  • Active Comparator: 1
    Group I
    Interventions:
    • Procedure: Vaginal Repair for prolapse, TVT procedure
    • Procedure: TVT and Prolapse surgery
  • Active Comparator: 2
    Group II
    Interventions:
    • Procedure: Vaginal Repair for prolapse, TVT procedure
    • Procedure: TVT and Prolapse surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
194
September 2007
September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria: Pelvic Organ Prolapse that needs surgical repair and objectively proven urinary stress incontinence -

Exclusion Criteria: Not agreed to participate in randomization

-

Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00308009
TVT Prolapse study
Yes
Ellen Borstad, MD, Ullevaal University Hospital
Ullevaal University Hospital
Not Provided
Principal Investigator: Ellen Borstad, MD Michael Abdelnoor Phd, Department of epidemiology (same hospital)
Ullevaal University Hospital
November 2007

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