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OpenTrials
Completed

NCT Number: NCT04571346

Female Sling Procedure

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

trans-obturator procedure

Procedure

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 outcomes

  1. tape migration

    Time frame: to be evaluated at 3rd month postoperative

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

  2. tape migration

    Time frame: to be evaluated at 6th month postoperative

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

  3. tape migration

    Time frame: to be evaluated at12th month postoperative

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

Secondary outcomes

  1. continence after surgery

    Time frame: to be evaluated at 3,6 and 12 month postoperative

    to evaluate success rate in treatment of stress urinary incontinence using stress cough test and urodynamic study

  2. de-novo urgency

    Time frame: to be evaluated at 12 month postoperative

    appearance of urgency incontinence from patient symptomology evaluation whether present or not

  3. vaginal erosion

    Time frame: to be evaluated up to 1 year post operative

    postoperative complication of TOT where vagina erosion may occur, (yes/no)

  4. urine retention

    Time frame: to be evaluated in the first 24 hours postoperative

    postoperative complication of TOT ( present or not)

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

A Two Paramedian Vaginal Incisions Versus the Standard Longitudinal Incision of Trans-Obturator Tape Procedure for Management of Urinary Incontinence

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 1, 2020
Registry last updated
Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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