Female Sling Procedure

Phase 2

Completed

• Conditions: Urinary Incontinence,Stress
• Interventions: Procedure: trans-obturator procedure

• Registration Number: NCT04571346
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2020-09
• Study First Submitted: 2020-09-19
• Study First Submitted QC: 2020-09-27
• Last Update Submitted: 2020-09-27
• Study First Posted: 2020-10-01
• Last Update Posted: 2020-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 paramedian vertical incisions	trans-obturator procedure	performing the trans-obturator procedure through a new technique of 2 paramedian vertical incisions
the classical TOT procedure	trans-obturator procedure	performing the trans-obturator procedure through the standard vertical incision

Primary Outcome Measures

Name	Time	Method
tape migration	to be evaluated at12th month postoperative	to evaluate TOT migration postoperative from the middle third of the urethra by trans-labial ultrasound

Secondary Outcome Measures

Name	Time	Method
continence after surgery	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
urine retention	to be evaluated in the first 24 hours postoperative	postoperative complication of TOT ( present or not)
de-novo urgency	to be evaluated at 12 month postoperative	appearance of urgency incontinence from patient symptomology evaluation whether present or not
vaginal erosion	to be evaluated up to 1 year post operative	postoperative complication of TOT where vagina erosion may occur, (yes/no)