Comparing two types of laparoscopic surgery for urinary incontinence
Official title: Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension For Treatment Of Female Stress Urinary Incontinence; Randomized Controlled Trial
Run by Al-Azhar University · NCT05616481 · Data updated 2026-11-12
This study is testing which of two types of laparoscopic surgery works better and has fewer complications for women with stress urinary incontinence who haven't found relief from other treatments.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 120 (estimated) |
| Sponsor | Al-Azhar University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Status | Recruiting |
| Started | January 1, 2022 |
| Main results expected | June 2025 |
| Study ends | July 2025 |
| Registry record updated | May 29, 2025 |
| Trial ID | NCT05616481 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women with genuine stress urinary incontinence or mixed urinary incontinence with a predominant stress element who have not found relief through conservative therapies.
✕Probably not a fit
Patients with predominant urge urinary incontinence or those who have had recent pelvic surgery or previous surgeries for stress urinary incontinence may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study compares the success rates and complications of two surgical techniques for treating stress urinary incontinence: standard laparoscopic Burch colposuspension and a modified version that resembles the transobturator tape method. The goal is to determine which approach offers better outcomes for women suffering from this condition. Participants will be women with genuine stress urinary incontinence or mixed urinary incontinence with a predominant stress component who have not responded to conservative treatments. The study will evaluate both the effectiveness and safety of these surgical interventions.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical options for women suffering from stress urinary incontinence.
How similar studies have gone: Other studies have explored various surgical techniques for urinary incontinence, but this specific comparison of laparoscopic Burch colposuspension methods is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with genuine stress urinary incontinence. * Mixed urinary incontinence with predominant stress element. * Refractory cases to conservative therapy or patients who are not willing to consider (further) conservative treatment. Exclusion Criteria: * Mixed incontinence with predominant Urge urinary incontinence. * Recent pelvic surgery (less than 3 months). * Neurogenic lower urinary tract dysfunction. * Previous surgery for stress urinary incontinence. * Pregnancy * Less than 12 months post-partum. * Other gynaecologic pathologies affecting bladder functions ( eg, fibroids, ovarian cysts) * Genito-urinary malignancy. * Current chemo or radiation therapy.
Where it's running
-
Mohamed Fawzy Salman
Cairo, Cairo Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Mohamed Fawzy Salman, MD
- Email: prof_mohamed_fawzy@yahoo.com
- Phone: +201111788996
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.