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

NCT05646745 | Recruiting

• 1 other identifier: Fascia Lata TOT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Stress Urinary Incontinence

Keywords

Autologous; TOT; SUI; Stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• improvement of SUI

  3 months

Study Arms (1)

Autologous Fascia lata TOT

EXPERIMENTAL

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

Interventions

Autologous Transobturator Fascia Lata Sling PROCEDURE

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.

Autologous Fascia lata TOT

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (2)

Mohamed Fawzy Salman

Cairo, Egypt

RECRUITING

Urology department - AlAzhar university

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mohamed F Salman, MD

CONTACT

00201111788996; Prof_mohamed_fawzy@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Autologous fascia lata is utilized via transobturator approach

Study Record Dates

• First Submitted: December 3, 2022
• First Posted: December 12, 2022
• Study Start: January 1, 2022
• Primary Completion: October 1, 2025
• Study Completion: January 1, 2026
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)