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临床试验/NCT05646745
NCT05646745招募中不适用

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

Al-Azhar University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
complete cure

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

complete cure

时间窗: 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.

次要结局

  • improvement of SUI(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Fawzy Abd Elfattah Salman

Director

Al-Azhar University

研究点 (2)

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