Female Sling Procedure

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence,Stress
• Intervention / Treatment: Procedure: trans-obturator procedure

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: September 19, 2020
• First Submitted That Met QC Criteria: September 27, 2020
• First Posted (Actual): October 1, 2020

Study Record Updates

• Last Update Posted (Actual): October 1, 2020
• Last Update Submitted That Met QC Criteria: September 27, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: FMASU R51/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No