Actively Recruiting
Autologous Transobturator Fascia Lata Sling in Treatment of Female Stress Urinary Incontinence
Led by Al-Azhar University · Updated on 2024-08-15
60
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the outcome of using an autologous transobturator fascia lata sling to treat female stress urinary incontinence at Al-Azhar university hospitals. The study focuses on women with genuine or predominant stress urinary incontinence who have not responded to or do not wish to pursue conservative treatments. The procedure involves making an incision in the lower lateral thigh to isolate a strip of fascia lata, which is then secured with sutures and passed through the obturator membrane with the help of a reusable C-shaped trocar. This sling is positioned flush with the mid-urethra and fixed in place to prevent movement. The operation is performed under anesthesia, and involves bladder drainage, hydro-distention of the anterior vaginal wall, and careful dissection. Participants will be monitored for outcomes such as complete cure and improvement of stress urinary incontinence at three months after the procedure. The study includes assessments of surgical success and safety, with follow-up to evaluate the effectiveness of the sling in controlling symptoms. Total participation duration and additional monitoring details are aligned with the three-month primary outcome measurement.
CONDITIONS
Brief Title
Autologous Transobturator Fascia Lata Sling in Treatment of Female Stress Urinary Incontinence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Mixed incontinence with predominant urge urinary incontinence
- Local abnormalities affecting 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 postpartum
- Other gynecologic pathologies affecting bladder function (e.g., large fibroids, ovarian cysts)
- Genito-urinary malignancy
- Current chemotherapy or radiation therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day or until discharge
Participants undergo surgery to implant the autologous transobturator fascia lata sling to treat stress urinary incontinence. This includes anesthesia, incisions on the vaginal wall and thigh to isolate and place the fascial strip, and securing the sling in place.
1 surgical visit and immediate post-operative monitoring
Duration - Up to 3 months
Participants are monitored after surgery to assess recovery and treatment outcomes including cure or improvement of stress urinary incontinence.
Approximately 3 follow-up visits
Trial Site Locations
Total: 2 locations
1
Mohamed Fawzy Salman
Cairo, Egypt
Actively Recruiting
2
Urology department - AlAzhar university
Cairo, Egypt
Actively Recruiting
Research Team
M
Mohamed F Salman, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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