A Two Paramedian Vaginal Incisions Versus the Standard Longitudinal Incision of Trans-Obturator Tape Procedure for Management of Urinary Incontinence
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Urinary Incontinence,Stress
- Sponsor
- Ain Shams University
- Enrollment
- 100
- Primary Endpoint
- tape migration
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Ahmed Maher Gamil Ahmed Higazy
assistant lecturer of Urology
Ain Shams University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
- continence after surgery(to be evaluated at 3,6 and 12 month postoperative)
- urine retention(to be evaluated in the first 24 hours postoperative)
- de-novo urgency(to be evaluated at 12 month postoperative)
- vaginal erosion(to be evaluated up to 1 year post operative)