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Mixed Urinary Incontinence Surgical Trial

Primary Purpose

Med: Urinary Incontinence (Stress, Urge, Mixed)

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Burch Colposuspension
trans obturator tape
tension free vaginal tape
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Med: Urinary Incontinence (Stress, Urge, Mixed)

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with Mixed urinary incontinence

Exclusion Criteria:

Women with associated gynecological surgery e.g. uterine prolapse, previous anti-incontinence surgery, intrinsic sphincter deficiency (ISD), and medical disorders affecting the bladder innervation as diabetes mellitus were excluded from the study. Women who improved on medical treatment with persistence of stress element only were also excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Burch

    Trans Obturator Tape

    Tension free vaginal tape

    Arm Description

    Burch Colposuspension

    Trans Obturator Tape sling

    Tension free vaginal tape sling

    Outcomes

    Primary Outcome Measures

    cure of Mixed incontinence
    compare the 3 groups as regard cure rate of both Components of mixed incontinence

    Secondary Outcome Measures

    Full Information

    First Posted
    March 10, 2017
    Last Updated
    July 26, 2022
    Sponsor
    Ain Shams Maternity Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03085979
    Brief Title
    Mixed Urinary Incontinence Surgical Trial
    Official Title
    Surgical Management of Mixed Urinary Incontinence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2014 (Actual)
    Primary Completion Date
    October 2018 (Actual)
    Study Completion Date
    May 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams Maternity Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Surgical management of mixed urinary incontinence
    Detailed Description
    Study to evaluate role of anti-incontinent surgery Burch colposuspension Tension free vaginal tape Trans obturator tape for the management of mixed urinary incontinence .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Med: Urinary Incontinence (Stress, Urge, Mixed)

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Burch
    Arm Type
    Experimental
    Arm Description
    Burch Colposuspension
    Arm Title
    Trans Obturator Tape
    Arm Type
    Experimental
    Arm Description
    Trans Obturator Tape sling
    Arm Title
    Tension free vaginal tape
    Arm Type
    Experimental
    Arm Description
    Tension free vaginal tape sling
    Intervention Type
    Procedure
    Intervention Name(s)
    Burch Colposuspension
    Intervention Description
    Anti-incontinent surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    trans obturator tape
    Intervention Description
    Anti-incontinent surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    tension free vaginal tape
    Intervention Description
    Anti-incontinent surgery
    Primary Outcome Measure Information:
    Title
    cure of Mixed incontinence
    Description
    compare the 3 groups as regard cure rate of both Components of mixed incontinence
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with Mixed urinary incontinence Exclusion Criteria: Women with associated gynecological surgery e.g. uterine prolapse, previous anti-incontinence surgery, intrinsic sphincter deficiency (ISD), and medical disorders affecting the bladder innervation as diabetes mellitus were excluded from the study. Women who improved on medical treatment with persistence of stress element only were also excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hamdy HA Ahmed Saaid, M.D
    Organizational Affiliation
    Fellow of OBS/GYN
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Mixed Urinary Incontinence Surgical Trial

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