Trans obturator tape fixation: mid urethral sling for female stress urinary incontinence
Study summary
The goal of this prospective interventional study is to compare the effectiveness of laparoscopic Burch colposuspension versus trans obturator tape in the treatment of stress urinary incontinence in adult females. The success rate will be compared between the two proceudres at 1, 3 and 6 months post operatively. Operative times, hospital stay and perioperative complications will be evaluated in both arms
Participants will be asked to:
* complete the ICIQ-UI-SF questionnaire pre operatively and at 1, 3 and 6 months post operatively
* undergo a pelvic examination pre operatively
* undergo cough stress test pre operatively and at 1, 3 and 6 months post operatively
* undergo a pressure flow study test pre operatively
* undergo pelviabdominal ultrasound with post void residual urine measurement pre operatively and at 1, 3 and 6 months post operatively
* undergo uroflowmetry at 1 month post operatively
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Clinical Diagnosis of SUI:
Symptoms include leakage during activities such as coughing, sneezing, laughing, or physical exertion.
* Documented stress urinary incontinence by physical examination and urodynamic testing.
* Adult female patients typically aged 18 years or older.
* Completed Non-Surgical Management:
Patients who have tried and failed conservative management options, such as pelvic floor exercises, behavioral therapy.
• Willingness to Undergo Surgery
Exclusion Criteria:
* virgin female
* mixed urinary Incontinence
* Pelvic Organ Prolapse more than the 2nd degree according to Baden and Walker classification 1992
* Previous Anti-Incontinence Surgery
* Neurological Conditions:
Patients with neurogenic bladder or other neurologic disorders affecting bladder function, such as multiple sclerosis or spinal cord injury.
* Pregnancy
* Presence of active urinary tract infection (UTI) or other pelvic infections at the time of evaluation
* Patients with interstitial cystitis, bladder tumors, or urethral diverticula that could complicate surgical outcomes
* Previous history of radiotherapy to the pelvis.
* Contraindications to surgery such as uncorrectable coagulation disorders
Primary outcome measure(s)
success rate — at 1, 3 and 6 months post operative the absence of a subjective complaint of leakage and the absence of objective leakage during a 250-ml cough stress test
Trial sites (2)
Facility
City
Region
Status
Cairo university hospitals
Giza
Giza Governorate
Theodor Bilharz Research Institute
Giza
Giza Governorate
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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