Clinical trial NCT05646745: Autologous Transobturator Fascia Lata Sling in Treatment of Female Stress Urinary Incontinence
Official title: Autologous Transobturator Fascia Lata Sling in Treatment of Female Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Autologous
TOT
SUI
Stress
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Autologous fascia lata is utilized via transobturator approach
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: complete cure
timeFrame: 3 months
Secondary outcomes:
measure: improvement of SUI
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mohamed Fawzy Salman
city: Cairo
country: Egypt
facility: Urology department - AlAzhar university
Study officials:
References: