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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05646745
• Other study ID #: Fascia Lata TOT
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: December 2022
• Source: Al-Azhar University
• Contact: Mohamed F Salman, MD
• Phone: 00201111788996
• Email: Prof_mohamed_fawzy[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

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.

Locations

Country	Name	City	State
Egypt	Mohamed Fawzy Salman	Cairo
Egypt	Urology department - AlAzhar university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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.	3 months