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Correction of Asymptomatic 2nd Degree Cystocele in Patient With Stress Incontinence

Sponsor
Kasr El Aini Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03296748
Collaborator
(none)
123
Enrollment
1
Location
2
Arms
15
Actual Duration (Months)
8.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of our study is to assess the value of concomitant surgical correction of asymptomatic grade II anterior vaginal wall prolapse with the placement of midurethral sling for treatment of female patients with stress incontinence

Condition or Disease Intervention/Treatment Phase
  • Procedure: trans-obturator tape inside-out usingsoft tapes.
  • Procedure: anterior colporraphy
 Phase 2/Phase 3

Detailed Description

female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and group B where' TOT was associated with anterior colporrhaphy and the outcome is compared.

Study Design

Study Type:
Interventional
Actual Enrollment :
123 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and group B where' TOT was associated with anterior colporrhaphy .female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and group B where' TOT was associated with anterior colporrhaphy .
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Is There Any Value of Concomitant Repair of Asymptomatic Grade II Anterior Vaginal Wall Prolapse During Mid Urethral Sling Surgery for Stress Urinary Incontinence ?
Actual Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Sep 1, 2017
Actual Study Completion Date :
Sep 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: TOT only group

60 patients with stress incontinence and asymptomatic grade 2 cystocele.

Procedure: trans-obturator tape inside-out usingsoft tapes.
trans-obturator tape inside-out soft tapes is applied under spinal anesthesia. After the procedure, the vaginal gauze packing and Foley catheter were removed on the morning of the next day.
Other Names:
  • anterior colporrhaphy

    		•
    Active Comparator: concomitant repair group

    63 patients with stress incontinence and asymptomatic grade 2 cystocele.

    Procedure: trans-obturator tape inside-out usingsoft tapes.
    trans-obturator tape inside-out soft tapes is applied under spinal anesthesia. After the procedure, the vaginal gauze packing and Foley catheter were removed on the morning of the next day.
    Other Names:
  • anterior colporrhaphy

    • Procedure: anterior colporraphy

    Outcome Measures

    Primary Outcome Measures

    1. cure rate of stress incontinence [3 months after surgery]

      by clinical assessment

    2. Denovo urgency [3 months after surgery]

      by clinical assessment

    Secondary Outcome Measures

    1. cure rate of stress incontinence [6 months after surgery]

      by clinical assessment

    2. cure rate of stress incontinence [12 months after surgery]

      by clinical assessment

    3. Denovo urgency [6 months after surgery]

      by clinical assessment

    4. Denovo urgency [12 months after surgery]

      by clinical assessment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    23 Years to 56 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • female patients

    • genuine stress incontinence

    • asymptomatic cystocele

    Exclusion Criteria:
    • mixed incontinence

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kasr El Ainiy Hospital Cairo Egypt 11562

    Sponsors and Collaborators

    • Kasr El Aini Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    sarah mohamed hassan, lecturer of obstetrics and gynecology Cairo university, Kasr El Aini Hospital
    ClinicalTrials.gov Identifier:
    NCT03296748
    Other Study ID Numbers:
    • 151115
    First Posted:
    Sep 28, 2017
    Last Update Posted:
    Oct 24, 2017
    Last Verified:
    Oct 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by sarah mohamed hassan, lecturer of obstetrics and gynecology Cairo university, Kasr El Aini Hospital
    asymptomatic cystocele.
    stress urinary incontinence
    Additional relevant MeSH terms:
    Urinary Incontinence
    Enuresis
    Urinary Incontinence, Stress

    Study Results

    No Results Posted as of Oct 24, 2017