Laparoscopic Burch Colposuspension Versus Transobturator Tape in the Treatment of Female Stress U… (NCT07398144) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Laparoscopic Burch Colposuspension Versus Transobturator Tape in the Treatment of Female Stress Urinary Incontinence.
Egypt60 participantsStarted 2025-05-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.