Female Stress Incontinence Clinical Trial
Official title:
Hybrid Versus Synthetic Transobturator Tape for Treatment of Female Stress Urinary Incontinence: Prospective Randomised Study
This prospective study is conducted on female patients presenting with SUI at Alexandria main university hospital. Patients with neurogenic voiding dysfunction, history of anti-incontinence surgery, urge-predominant MUI, urogenital cancer, pelvic irradiation, body mass index more than 40 kg/m2 and more than stage 1 POP are excluded. Patients are randomized into 2 groups, one group will be subjected to h_TOT, and the second group to conventional TOT. Patients are subjected to PGI and UDI-6 questionnaires and a urodynamic study before and 6 months after the both surgery. Success is defined as: no subjective complaint of SUI, negative cough stress test and no leakage on UDS.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | January 15, 2023 |
Est. primary completion date | January 5, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Alexandria Faculty of Medicine | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Alexandria University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dryness | Absence of clinical and urodynamic stress incontinence | 6 months |
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