Autologous Transobturator Fascia Lata Sling in Treatment of Female Stress Urinary Incontinence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autologous Transobturator Fascia Lata Sling.
- Who it may be relevant to
- Registry conditions: Stress Urinary Incontinence. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To evaluate the outcome of autologous transobturator fascia lata sling for treatment of female stress urinary incontinence at Al-Azhar university hospitals.
Detailed description
Following induction of anesthesia and administration of perioperative antibiotics, the patient is positioned in the dorsal lithotomy position, sterilization and draping will be done. A sterile 16 French Foley catheter is placed to drain the bladder, following this, injectable normal saline is utilized using 10 cc syringe for hydro-distention of the anterior vaginal wall, and a midline incision is made based on the mid-urethra. Dissection is carried out bilaterally to the obturator Foramen on both sides.
Through incision in the lower lateral aspect of the thigh, 4 cm above the knee, \~1 cm× \~5 cm fascial strip is isolated from the fascia lata. Two stay sutures are secured to the corners of the fascial segment on each side.
About 1cm skin incision is performed at the thigh fold on each side. Next, two separate trocar passages are performed on each side using a reusable C-shaped trocar, with care taken to ensure at least a 1 cm tissue bridge in the obturator membrane between the superior and inferior passes. Following this, the stay sutures are tied external to the obturator membrane on both sides, leaving the sling secured and flush with the mid-urethra. Sutures are also placed to secure the sling to the periurethral tissue to prevent rolling or migration of the fascial strip.
Interventions
- Procedure Autologous Transobturator Fascia Lata Sling
Hydro-distention of the anterior vaginal wall, and a midline incision is made based on the mid-urethra. Dissection is carried out bilaterally to the obturator Foramen on both sides. Through incision in the lower lateral aspect of the thigh, 4 cm above the knee, \~1 cm× \~5 cm fascial strip is isolated from the fascia lata. Two stay sutures are secured to the corners of the fascial segment on each side. About 1cm skin incision is performed at the thigh fold on each side. Next, two separate troc
Primary outcome measures
- complete cure [Time frame: 3 months]
Secondary outcome measures (1)
- improvement of SUI [Time frame: 3 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 2 centers
- Mohamed Fawzy Salman — Cairo
- Urology department - AlAzhar university — Cairo
Publications
- Salman MFA, Hassan AA, Wasfy IS, Deif H, Hassan AA, Hindawy MA, Hassan AMA, Ali MM, Abdel-Al I, Koritenah AK, Abuelazayem TM, Keritna HKM. Autologous Transobturator Fascia Lata Sling for Female Stress Urinary Incontinence: A Pilot Feasibility and Safety Study. Low Urin Tract Symptoms. 2026 Sep;18(5):e70085. doi: 10.1111/luts.70085. PMID 42521462
Identifiers
NCT: NCT05646745 · Fascia Lata TOT