Long-term outcomes of a new surgical approach for treating female urinary incontinence
Long-term Outcomes of Autologous Transobturator Rectus Fascia Sling for Treatment of Female Stress Urinary Incontinence, Prospective Trial
This study is testing a new surgery using a woman's own tissue to see if it can effectively treat stress urinary incontinence for those who haven't found relief with other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Sex | Female |
| Sponsor | Al-Azhar University Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Cairo and 1 other locations) |
| Trial ID | NCT05647070 on ClinicalTrials.gov |
What this trial studies
This study evaluates the long-term outcomes of using an autologous transobturator rectus fascia sling to treat female stress urinary incontinence (SUI). SUI affects a significant percentage of women, and while current treatments often involve synthetic materials, this approach aims to reduce associated risks by using the patient's own tissue. The study will assess the effectiveness and safety of this surgical technique over an extended period, following promising short-term results. Participants will be women with SUI who have not responded to conservative treatments or prefer surgical options.
Who should consider this trial
Good fit: Ideal candidates for this study are women experiencing genuine stress urinary incontinence or mixed urinary incontinence with a predominant stress element.
Not a fit: Patients with mild stress urinary incontinence who improve with conservative therapy or those with predominant urge urinary incontinence may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective treatment option for women suffering from stress urinary incontinence.
How similar studies have performed: While there have been successful studies using autologous slings, this specific transobturator approach is relatively novel and aims to further validate its long-term efficacy.
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: * Mild Stress urinary incontinence with improvement on conservative therapy or patients refusing surgical treatment. * Mixed incontinence with predominant Urge urinary incontinence. * Associated local abnormalities (e.g. cystocele). * 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) * 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)
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.