Long-term Outcomes of Autologous Transobturator Rectus Fascia Sling for Treatment of Female Stress Urinary Incontinence

NCT05647070 | Recruiting DMC

• 1 other identifier: autologous transobturator tape
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

Autologous transobturator sling placement is associated with excellent short-term results and can be performed on an outpatient basis in most cases, so long-term outcomes needs to be verified.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Complete cure OR improvement of SUI

  Complete cure means no leak on cough stress test and the patient in satisfied on "patient reported outcome". Improvement means patient reported leakage only with severe exertion and using a smaller number of pads per day and she feels that she has improved. On examination there was no stress urinary incontinence. Failure is considered when patients not fulfilling these criteria

  one year

Secondary Outcomes (3)

• Complications of Autologous TOT

  one year

• Estimated blood loss

  24 hours

• Operative time

  2 hours

Study Arms (1)

Autologous rectus Fascia TOT

EXPERIMENTAL

A sterile 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 Pfannestiel incision, \~1 cm× \~5 cm rectus fascia strip is isolated from the anterior rectus sheath. Two stay sutures are secured to the corner of the fascial segment 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

Procedure: Autologous rectus Fascia TOT

Interventions

Autologous rectus Fascia TOT PROCEDURE

A sterile 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 Pfannestiel incision, \~1 cm× \~5 cm rectus fascia strip is isolated from the anterior rectus sheath. Two stay sutures are secured to the corner of the fascial segment 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

Autologous rectus Fascia 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:

• Mild Stress urinary incontinence with improvement on conservative therapy or patients refusing surgical treatment.
• Mixed incontinence with predominant Urge urinary incontinence.
• Associated local abnormalities (e.g. cystocele).
• 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)
• 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

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: A sterile 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 Pfannestiel incision, \~1 cm× \~5 cm rectus fascia strip is isolated from the anterior rectus sheath. Two stay sutures are secured to the corner of the fascial segment 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

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 12, 2022
• Study Start: December 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: January 1, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)