RecruitingNot ApplicableNCT05647070

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

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


Sponsor

Al-Azhar University

Enrollment

200 participants

Start Date

Dec 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALE

Inclusion Criteria3

  • 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 Criteria12

  • 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.

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Interventions

PROCEDUREAutologous rectus Fascia TOT

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


Locations(2)

Mohamed Fawzy Salman

Cairo, Egypt

Urology department - Alazhar university

Cairo, Egypt

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NCT05647070


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