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

Primary Purpose

Pelvic Organ Prolapse, Urinary Stress Incontinence

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vaginal Repair for prolapse, TVT procedure
TVT and Prolapse surgery
Sponsored by
Ullevaal University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Pelvic Organ Prolapse, Urinary stress incontinence, Surgery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Pelvic Organ Prolapse that needs surgical repair and objectively proven urinary stress incontinence - Exclusion Criteria: Not agreed to participate in randomization -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Group I, Prolapse repair and TVT concomitantly

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

    Outcomes

    Primary Outcome Measures

    Any or no leakage of urine when coughing

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    March 27, 2006
    Last Updated
    April 27, 2015
    Sponsor
    Ullevaal University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00308009
    Brief Title
    Comparison of the Result of TVT Performed at the Time of Prolapse Surgery or 3 Months After
    Official Title
    Multicenter Prospective Randomized Trial Comparing to Strategies When Incontinence Surgery is Needed in Addition to Prolapse Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2002 (undefined)
    Primary Completion Date
    September 2007 (Actual)
    Study Completion Date
    September 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Ullevaal University Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pelvic Organ Prolapse, Urinary Stress Incontinence
    Keywords
    Pelvic Organ Prolapse, Urinary stress incontinence, Surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    194 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Group I, Prolapse repair and TVT concomitantly
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Group II, Prolapse repair and TVT 3 months afterwards if necessary
    Intervention Type
    Procedure
    Intervention Name(s)
    Vaginal Repair for prolapse, TVT procedure
    Other Intervention Name(s)
    Incontinence surgery, Mid-urethra sling, Prolapse surgery., Prolapse repair
    Intervention Description
    TVT at the time of Vaginal Repair TVT 3 months after Vaginal Repair
    Intervention Type
    Procedure
    Intervention Name(s)
    TVT and Prolapse surgery
    Intervention Description
    TVT at the time of Prolapse surgery TVT 3 months after Prolapse Surgery
    Primary Outcome Measure Information:
    Title
    Any or no leakage of urine when coughing
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    The cure of urinary stress incontinence (USI) by only prolapse surgery
    Time Frame
    1 year
    Title
    Result of prolapse surgery in two intervention strategies in women suffering from both genital prolapse and USI
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Pelvic Organ Prolapse that needs surgical repair and objectively proven urinary stress incontinence - Exclusion Criteria: Not agreed to participate in randomization -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ellen Borstad, MD
    Organizational Affiliation
    Michael Abdelnoor Phd, Department of epidemiology (same hospital)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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