Using a patient's own tissue to treat female stress urinary incontinence
Autologous Transobturator Fascia Lata Sling in Treatment of Female Stress Urinary Incontinence
This study is testing whether using a strip of tissue from a woman's thigh can help treat her stress urinary incontinence and improve her quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Sex | Female |
| Sponsor | Al-Azhar University Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Cairo and 1 other locations) |
| Trial ID | NCT05646745 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of an autologous transobturator fascia lata sling for treating female stress urinary incontinence at Al-Azhar University hospitals. The procedure involves harvesting a strip of fascia lata from the patient's thigh and using it to create a supportive sling for the urethra. Patients undergo anesthesia and are positioned for surgery, where the sling is secured to prevent migration and ensure proper support. The study aims to assess the outcomes of this surgical intervention in women with stress urinary incontinence.
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 component who have not responded to conservative treatments.
Not a fit: Patients with predominant urge urinary incontinence or those with significant pelvic abnormalities may not benefit from this procedure.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and durable solution for women suffering from stress urinary incontinence.
How similar studies have performed: Other studies have shown promising results with similar surgical approaches, indicating potential effectiveness in treating stress urinary incontinence.
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. * Associated local abnormalities that may affect surgery outcomes (e.g. complete procidentia). * Recent or active urinary tract infection. * Recent pelvic surgery. * 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, large fibroids, ovarian cysts) * Genito-urinary malignancy. * Current chemo or radiation therapy.
Where this trial is running
Cairo and 1 other locations
- Mohamed Fawzy Salman — Cairo, Egypt (Recruiting)
- Urology department - AlAzhar university — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed F Salman, MD
- Email: Prof_mohamed_fawzy@yahoo.com
- Phone: 00201111788996
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.