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Female Sling Procedure

Primary Purpose

Urinary Incontinence,Stress

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
trans-obturator procedure
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence,Stress

Eligibility Criteria

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

Inclusion Criteria:

  • adult female patient complaining of pure stress incontinence confirmed by stress test of urodynamic study

Exclusion Criteria:

  • Patients with neurological disease, pelvic organ prolapse, previous urethral or pelvic floor surgery will be excluded from our study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    the classical TOT procedure

    2 paramedian vertical incisions

    Arm Description

    performing the trans-obturator procedure through the standard vertical incision

    performing the trans-obturator procedure through a new technique of 2 paramedian vertical incisions

    Outcomes

    Primary Outcome Measures

    tape migration
    to evaluate TOT migration postoperative from the middle third of the urethra by trans-labial ultrasound
    tape migration
    to evaluate TOT migration postoperative from the middle third of the urethra by trans-labial ultrasound
    tape migration
    to evaluate TOT migration postoperative from the middle third of the urethra by trans-labial ultrasound

    Secondary Outcome Measures

    continence after surgery
    to evaluate success rate in treatment of stress urinary incontinence using stress cough test and urodynamic study
    de-novo urgency
    appearance of urgency incontinence from patient symptomology evaluation whether present or not
    vaginal erosion
    postoperative complication of TOT where vagina erosion may occur, (yes/no)
    urine retention
    postoperative complication of TOT ( present or not)

    Full Information

    First Posted
    September 19, 2020
    Last Updated
    September 27, 2020
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04571346
    Brief Title
    Female Sling Procedure
    Official Title
    A Two Paramedian Vaginal Incisions Versus the Standard Longitudinal Incision of Trans-Obturator Tape Procedure for Management of Urinary Incontinence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (Actual)
    Primary Completion Date
    February 2018 (Actual)
    Study Completion Date
    February 2018 (Actual)

    3. Sponsor/Collaborators

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

    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
    In trans-obturator tape (TOT), tension and location of the tape in mid urethral zone are directly related to the postoperative clinical outcome. Recurrence of symptoms of stress urinary incontinence has been related to tape migration in previous studies. The study aimed to increase the success rate of TOT procedure through a new surgical technique using a 2 paramedian vaginal incisions.
    Detailed Description
    the investigator innovated a new technique that involves a 2 paramedian vaginal incisions that allow more tape stabilization with sparing the dissection along the whole urethra ensuring intact overlying tissues and to create a tunnel in between the 2 incisions to pass the tape, making it supported proximally and distally with normal undissected tissues. the study aims to assess the success rate of TOT and tape migration using a new surgical technique versus the standard procedure using vertical incision.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Incontinence,Stress

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Female patients complaining of stress urinary incontinence will be selected for our study, at the urology department, Ain-shams University hospitals. Those patients will be randomized into 2 equal groups with a 1:1 ratio using sealed envelopes that will be prepared by the department's ethical committee, group 1 represents the classical TOT procedure while group 2 represents the 2 paramedian vertical incisions technique. Patients will be blinded to the type of intervention. Informed consent will be obtained for all patients before the surgery, Careful evaluation will be done including history taking, examination with a stress test and urodynamic study. Patients with neurological disease, pelvic organ prolapse, previous urethral or pelvic floor surgery will be excluded from our study.
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    Patients will be blinded to the type of intervention as well as the data collector and the statistician
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    the classical TOT procedure
    Arm Type
    Active Comparator
    Arm Description
    performing the trans-obturator procedure through the standard vertical incision
    Arm Title
    2 paramedian vertical incisions
    Arm Type
    Experimental
    Arm Description
    performing the trans-obturator procedure through a new technique of 2 paramedian vertical incisions
    Intervention Type
    Procedure
    Intervention Name(s)
    trans-obturator procedure
    Intervention Description
    TOT procedure will be done using silicon-coated polypropylene tape that will be inserted at the mid-urethral portion. In group 1, a classical vertical vaginal incision will be done proximal to the external urethral meatus with dissection along the axis of the urethra till the mid-urethral zone that is identified by palpating the urethral catheter balloon through the vaginal at the bladder neck, while in group 2, two paramedian incisions will be done 1cm long in the anterior vaginal wall 2 cm apart parallel to the urethra till identification of the mid-urethral portion, communication will be done between the two incisions 1 cm wide in this area creating a tunnel where the tape will be placed, this technique provides healthy tissues proximal and distal to the tape that allows more stabilization and less migration. The rest of the procedure is the same as the standard procedure of Trans-obturator outside-in tension-free technique.
    Primary Outcome Measure Information:
    Title
    tape migration
    Description
    to evaluate TOT migration postoperative from the middle third of the urethra by trans-labial ultrasound
    Time Frame
    to be evaluated at 3rd month postoperative
    Title
    tape migration
    Description
    to evaluate TOT migration postoperative from the middle third of the urethra by trans-labial ultrasound
    Time Frame
    to be evaluated at 6th month postoperative
    Title
    tape migration
    Description
    to evaluate TOT migration postoperative from the middle third of the urethra by trans-labial ultrasound
    Time Frame
    to be evaluated at12th month postoperative
    Secondary Outcome Measure Information:
    Title
    continence after surgery
    Description
    to evaluate success rate in treatment of stress urinary incontinence using stress cough test and urodynamic study
    Time Frame
    to be evaluated at 3,6 and 12 month postoperative
    Title
    de-novo urgency
    Description
    appearance of urgency incontinence from patient symptomology evaluation whether present or not
    Time Frame
    to be evaluated at 12 month postoperative
    Title
    vaginal erosion
    Description
    postoperative complication of TOT where vagina erosion may occur, (yes/no)
    Time Frame
    to be evaluated up to 1 year post operative
    Title
    urine retention
    Description
    postoperative complication of TOT ( present or not)
    Time Frame
    to be evaluated in the first 24 hours postoperative

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    we evaluation the procedure of trans-obturator tape in female stress incontinence
    Minimum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: adult female patient complaining of pure stress incontinence confirmed by stress test of urodynamic study Exclusion Criteria: Patients with neurological disease, pelvic organ prolapse, previous urethral or pelvic floor surgery will be excluded from our study.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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