Hybrid Versus Synthetic TOT for Treatment of SUI
Female Stress Incontinence
About this trial
This is an interventional treatment trial for Female Stress Incontinence
Eligibility Criteria
Inclusion Criteria:
- Clinically proven SUI or stress-predominant mixed urinary incontinence by cough stress test.
Exclusion Criteria:
• Patients with neurogenic voiding dysfunction.
- History of anti-incontinence surgery.
- Presence of urge-predominant mixed urinary incontinence.
- Peripheral neuropathy.
- Multiple sclerosis.
- History of urogenital cancer.
- Pelvic irradiation
- Body mass index more than 40 kg/m2
- The presence of more than stage 2 pelvic organ prolapse as per pelvic organ prolapse quantification (POP-Q) system score.
- Active urinary tract infection
- Pregnant women
Sites / Locations
- Alexandria Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Hybrid transobturator tape
Conventional transobturator tape
Anterior rectus fascia will be exposed and an approximately 8-10 cm × 1 cm strip of rectus fascia will be marked out. The sling will be harvested using sharp dissection. Thereafter, a Polyprolene monofilamentous mesh of 15 cm x 1 cm will be sutured to each edge of the rectus fascia sling that had been harvested. Then, a 2-cm midline incision over the anterior vaginal wall at the level of mid-urethra. A combination of blunt and sharp dissection will be carried out to the obturator foramen bilaterally. Next, a stab incision will be made at a point approximately 2.5 cm infero-lateral to the pubic tubercle bilaterally, corresponding to the level of clitoris. A trocar will be passed through each obturator foramen (outside-in) and the edge of the mesh will be retracted through the incision. Next, the retraction of both meshes will continue until the rectus fascia sling remain flushed with the urethra.
The conventional mesh using mid urethral sling through the trans obturator route