An interventional study of Autologous Transobturator Fascia Lata Sling in Stress Urinary Incontinence, sponsored by Al-Azhar University. Status unknown at 2 sites in Egypt. Open to female participants. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
To evaluate the outcome of autologous transobturator fascia lata sling for treatment of female stress urinary incontinence at Al-Azhar university hospitals.
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.
671 studies on the registry are indexed under Urinary Incontinence, Stress; 122 are open to participants now.
This study's planned enrollment of 60 is below the median of 69 across 520 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →Al-Azhar University is the lead sponsor of 525 studies on the registry; 171 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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 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.
complete cure
Number of patients without leakage with cough stress test and the patient is satisfied and on examination there is no leakage with cough test.
Time frame: 3 months
improvement of SUI
Number of patients who report leakage only with severe exertion and using a smaller number of pads per day and she feels that she has improved. On examination there is no stress urinary incontinence.
Time frame: 3 months
Plan to share: No
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Urinary Incontinence, Stress →