Autologous Transobturator Fascia Lata Sling in Treatment of Female Stress Urinary Incontinence

Обзор

To evaluate the outcome of autologous transobturator fascia lata sling for treatment of female stress urinary incontinence at Al-Azhar university hospitals.

Подробное описание

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.

Вмешательства

• Процедура 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

Первичные конечные точки

• complete cure [Срок оценки: 3 months]

Вторичные конечные точки (1)

• improvement of SUI [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 2 центра

• Mohamed Fawzy Salman — Cairo
• Urology department - AlAzhar university — Cairo

Публикации

• 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

Идентификаторы

NCT: NCT05646745 · Fascia Lata TOT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗