Clinical trial NCT04571346: Female Sling Procedure
Official title: A Two Paramedian Vaginal Incisions Versus the Standard Longitudinal Incision of Trans-Obturator Tape Procedure for Management of Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Urinary Incontinence,Stress
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: tape migration
timeFrame: to be evaluated at 3rd month postoperative
measure: tape migration
timeFrame: to be evaluated at 6th month postoperative
measure: tape migration
timeFrame: to be evaluated at12th month postoperative
Secondary outcomes:
measure: continence after surgery
timeFrame: to be evaluated at 3,6 and 12 month postoperative
measure: de-novo urgency
timeFrame: to be evaluated at 12 month postoperative
measure: vaginal erosion
timeFrame: to be evaluated up to 1 year post operative
measure: urine retention
timeFrame: to be evaluated in the first 24 hours postoperative
Other outcomes:
Locations:
Study officials:
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