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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
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.
tape migration
to evaluate TOT migration postoperative from the middle third of the urethra by trans-labial ultrasound
Time frame: 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
Time frame: 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
Time frame: to be evaluated at12th month postoperative
continence after surgery
to evaluate success rate in treatment of stress urinary incontinence using stress cough test and urodynamic study
Time frame: 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
Time frame: to be evaluated at 12 month postoperative
vaginal erosion
postoperative complication of TOT where vagina erosion may occur, (yes/no)
Time frame: to be evaluated up to 1 year post operative
urine retention
postoperative complication of TOT ( present or not)
Time frame: to be evaluated in the first 24 hours postoperative
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