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临床试验/NCT07384117
NCT07384117
进行中(未招募)
不适用

Long-term Outcomes of Urethral Ligament Plication and Uterosacral Ligament Plication: a Multicenter Prospective Study

Alev Esercan1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年2月1日最近更新:

概览

阶段
不适用
状态
进行中(未招募)
发起方
Alev Esercan
入组人数
200
试验地点
1
主要终点
The success (continence) rates after the operations

概览

简要总结

The aim of this study is to determine the long-term success and outcomes of urethral ligament plication surgeries in patients with stress incontinence and uterosacral ligament plication surgeries in patients with urge incontinence.

详细描述

For patients experiencing stress urinary incontinence during coughing and sneezing, which increases the intra-abdominal pressure, urethral ligament (pubourethral ligament/external urethral ligament) surgery will be performed. For patients with urge incontinence (inability to hold urine immediately) and posterior compartment syndrome (nocturia, constipation/fecal incontinence), uterosacral ligament plication surgery will be performed. For patients with both types of urinary incontinence, both surgeries will be performed, and the 2-year postoperative results will be evaluated.

This study will be a double-blind, prospective experimental study. Patients with stress urinary incontinence will undergo preoperative examination using an integral theory questionnaire to assess their symptoms and complaints anatomically and physiologically. The surgeon will always be the same person (Esercan A), and patients will be called for a follow-up examination two years after surgery (routine postoperative check-ups will be performed, but our study will focus on the results at the end of the second year). This examination will be conducted by the same surgeon, different from those who performed the surgery and published the findings, and the integral theory questionnaire will be used again for evaluation. Integral theory was defined in the literature by Professor Peter Emanuel Papa Petros from our research team, and he also provided the integral theory questionnaire. We already use this questionnaire in routine practice. Additionally, any postoperative complications will be recorded in detail.

研究设计

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

入排标准

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

入选标准

  • Patients aged 18 and over with urinary incontinence (stress or urge incontinence, or both)
  • Agreement to undergo surgery
  • No contraindications for anesthesia for surgery

排除标准

  • Pregnancy
  • Being under 18 years of age
  • Suspicion of malignancy
  • Urinary incontinence due to neurogenic bladder
  • Presence of intrinsic sphincter (urethral) insufficiency

研究组 & 干预措施

Urinary incontinent patients will have surgeries according to their incontinence type "stress"

Experimental

Urethral plication surgery (ULP) will be done for stress incontinence

干预措施: uterosacral ligament plication, urethral ligament plication (Procedure)

Urinary incontinent patients will have surgeries according to their incontinence type "urge"

Experimental

USL for urge urinary incontinence will be done.

干预措施: uterosacral ligament plication, urethral ligament plication (Procedure)

结局指标

主要结局

The success (continence) rates after the operations

时间窗: At postoperative first and second year

Urinary incontinence status will be evaluated by Integral Theory Questionnaire and examinations at postoperative first and second year

次要结局

  • The complications(At second postoperative year)

研究者

发起方
Alev Esercan
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Alev Esercan

Assoc. Prof.

Sanliurfa Education and Research Hospital

研究点 (1)

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