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NCT Number: NCT05646745

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. complete cure

    Time frame: 3 months

    Number of patients without leakage with cough stress test and the patient is satisfied and on examination there is no leakage with cough test.

Secondary outcomes

  1. improvement of SUI

    Time frame: 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed F Salman, MD

CONTACT

[email protected]

00201111788996

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Dec 12, 2022
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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