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

Sponsor
Ullevaal University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00308009
Collaborator
(none)
194
Enrollment
2
Arms
67
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Vaginal Repair for prolapse, TVT procedure
  • Procedure: TVT and Prolapse surgery
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
194 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multicenter Prospective Randomized Trial Comparing to Strategies When Incontinence Surgery is Needed in Addition to Prolapse Surgery
Study Start Date :
Feb 1, 2002
Actual Primary Completion Date :
Sep 1, 2007
Actual Study Completion Date :
Sep 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Group I, Prolapse repair and TVT concomitantly

Procedure: Vaginal Repair for prolapse, TVT procedure
TVT at the time of Vaginal Repair TVT 3 months after Vaginal Repair
Other Names:
  • Incontinence surgery
  • Mid-urethra sling
  • Prolapse surgery.
  • Prolapse repair

    • Procedure: TVT and Prolapse surgery
    TVT at the time of Prolapse surgery TVT 3 months after Prolapse Surgery
    Active Comparator: 2

    Group II, Prolapse repair and TVT 3 months afterwards if necessary

    Procedure: Vaginal Repair for prolapse, TVT procedure
    TVT at the time of Vaginal Repair TVT 3 months after Vaginal Repair
    Other Names:
  • Incontinence surgery
  • Mid-urethra sling
  • Prolapse surgery.
  • Prolapse repair

    • Procedure: TVT and Prolapse surgery
    TVT at the time of Prolapse surgery TVT 3 months after Prolapse Surgery

    Outcome Measures

    Primary Outcome Measures

    1. Any or no leakage of urine when coughing [1 year]

    Secondary Outcome Measures

    1. The cure of urinary stress incontinence (USI) by only prolapse surgery [1 year]

    2. Result of prolapse surgery in two intervention strategies in women suffering from both genital prolapse and USI [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

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

    Exclusion Criteria: Not agreed to participate in randomization

    -

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ullevaal University Hospital

    Investigators

    • Principal Investigator: Ellen Borstad, MD, Michael Abdelnoor Phd, Department of epidemiology (same hospital)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00308009
    Other Study ID Numbers:
    • TVT Prolapse study
    First Posted:
    Mar 28, 2006
    Last Update Posted:
    Apr 28, 2015
    Last Verified:
    Nov 1, 2007
    Keywords provided by , ,
    Pelvic Organ Prolapse
    Urinary stress incontinence
    Surgery
    Additional relevant MeSH terms:
    Urinary Incontinence, Stress
    Prolapse
    Pelvic Organ Prolapse

    Study Results

    No Results Posted as of Apr 28, 2015