Female Sling Procedure

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Urinary Incontinence,Stress

Intervention / Treatment
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* Procedure: trans-obturator procedure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: the classical TOT procedure<br>performing the trans-obturator procedure through the standard vertical incision | Procedure: trans-obturator procedure<br>* 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.<br>|
| Experimental: 2 paramedian vertical incisions<br>performing the trans-obturator procedure through a new technique of 2 paramedian vertical incisions | Procedure: trans-obturator procedure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tape migration | to evaluate TOT migration postoperative from the middle third of the urethra by trans-labial ultrasound | to be evaluated at 3rd month postoperative | 
| tape migration | to evaluate TOT migration postoperative from the middle third of the urethra by trans-labial ultrasound | to be evaluated at 6th month postoperative | 
| tape migration | to evaluate TOT migration postoperative from the middle third of the urethra by trans-labial ultrasound | to be evaluated at12th month postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| continence after surgery | to evaluate success rate in treatment of stress urinary incontinence using stress cough test and urodynamic study | to be evaluated at 3,6 and 12 month postoperative | 
| de-novo urgency | appearance of urgency incontinence from patient symptomology evaluation whether present or not | to be evaluated at 12 month postoperative | 
| vaginal erosion | postoperative complication of TOT where vagina erosion may occur, (yes/no) | to be evaluated up to 1 year post operative | 
| urine retention | postoperative complication of TOT ( present or not) | to be evaluated in the first 24 hours postoperative |