Female Sling Procedure

Urinary Incontinence,Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04571346
• Other study ID #: FMASU R51/2019
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 2016
• Est. completion date: February 2018

Study information

• Verified date: September 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urinary Incontinence,Stress

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	de-novo urgency	appearance of urgency incontinence from patient symptomology evaluation whether present or not	to be evaluated at 12 month postoperative
Secondary	vaginal erosion	postoperative complication of TOT where vagina erosion may occur, (yes/no)	to be evaluated up to 1 year post operative
Secondary	urine retention	postoperative complication of TOT ( present or not)	to be evaluated in the first 24 hours postoperative