Comparing two types of laparoscopic surgery for urinary incontinence
Laparoscopic Burch Colposuspension Versus Modified Burch Colposuspension For Treatment Of Female Stress Urinary Incontinence; Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Al-Azhar University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Trial ID | NCT05616481 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have explored various surgical techniques for urinary incontinence, but this specific comparison of laparoscopic Burch colposuspension methods is relatively novel.
Eligibility criteria
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 this trial is running
Cairo, Cairo Governorate
- Mohamed Fawzy Salman — Cairo, Cairo Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed Fawzy Salman, MD
- Email: prof_mohamed_fawzy@yahoo.com
- Phone: +201111788996
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.