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临床试验/NCT06334848
NCT06334848尚未招募不适用

Efficacy of Mini Sling Versus Transobturator Tape in Surgical Management of Women With Stress Urinary Incontinence

Ain Shams University0 个研究点目标入组 42 人开始时间: 2024年4月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
42
主要终点
Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding postoperative pain

研究概览

简要总结

To compare the efficacy of mini sling against Transobturator tape for surgical management of women with stress urinary incontinence.

详细描述

Urinary incontinence is defined as involuntary loss of urine and is divided into subtypes according to symptoms. These subtypes include SUI, in which urine loss occurs during exertion, physical exercise, coughing or sneezing; urgency urinary incontinence (UUI), in which urine loss is associated with urinary urgency; and mixed urinary incontinence (MUI), which is characterized by the association of stress loss with urgency.

There are non-surgical treatments (e.g., lifestyle modifications, pharmacotherapy, physiotherapy and vaginal pessary) and surgical treatments.

As regards sling use, it was found that mid urethral slings techniques achieved high cure rates in women with SUI and have become the mainstay for surgical treatment of SUI in women over the last 2 decades.

One of the modalities of such procedures is the transobturator mid urethral tape (TOT). It was introduced to minimize the complications of the previous retropubic tapes, which include injury to the bladder, major vessels, and bowel.

In an effort to maintain efficacy while eliminating some of the side effects, a new generation of tapes has been developed, called single incision tapes or mini-slings. They are designed to be shorter in length than standard mid-urethral slings and do not penetrate the tissues as deeply as standard slings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 60 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with a medical history of SUI
  • mixed urinary incontinence (MUI) in which SUI had to be the dominating symptom
  • confirmed by a positive standardized cough test with 300 cm3 water in the bladder

排除标准

  • Women will be excluded if they are aged >60 years
  • had previous incontinence or pelvic organ prolapse surgery
  • planned or present pregnancy
  • residual urine volume>100 ml
  • previous pelvic irradiation
  • neurological conditions such as multiple sclerosis
  • current treatment with corticoids
  • history of genital or abdominal cancer or a pelvic mass.

结局指标

主要结局

Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding postoperative pain

时间窗: one year

comparing between mini sling and transobturator tape in surgical management of women with stress urinary incontinence regarding: • Post operative pain measured by NRS(numerical rating pain score)

Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding incidence of complications

时间窗: one year

comparing between mini sling and transobturator tape in surgical management of women with stress urinary incontinence regarding: • Urinary continence measured by ICIQ(international continence index questionnaire)

次要结局

  • Comparing Mini Sling and Transobturator Tape in Surgical Management of Women with Stress Urinary Incontinence regarding sexual function(one year)

研究者

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

Tarek Salem Rezk

Principal Investigator

Ain Shams University

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