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临床试验/NCT05432869
NCT05432869Unknown不适用

Effects of External Electrical Stimulating Applied on the Thigh in Men With Urinary Incontinence After Prostatectomy

Ankara Yildirim Beyazıt University0 个研究点目标入组 40 人开始时间: 2022年7月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
主要终点
Urinary incontinence severity

研究概览

简要总结

The aim of this study is to investigate the effects of external electrical stimulation applied on the thigh on urinary symptoms, quality of life, sexual function, perception of subjective improvement and satisfaction in men with urinary incontinence after prostatectomy

详细描述

The most common complication after prostatectomy surgeries is urinary incontinence. There are conservative and surgical treatment options in post-prostatectomy urinary incontinence. One of the conservative treatment options is electrical stimulation application.

Electrical stimulation with the intraanal probe in men is painful and uncomfortable.

And also there are few studies, demonstrating the effects of electrical stimulation on urinary incontinence after prostatectomy in the literature.

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
40 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Being a male individual with stress or stress-dominant mixed urinary incontinence symptoms after undergoing prostatectomy surgery
  • Being over 40 years old
  • Not having residual cancerous tissue
  • Volunteering to participate in the study

排除标准

  • Having serious cardiovascular disease (unstable angina and arrhythmia patients, heart failure patients, etc.)
  • Having sensory loss
  • Having an ongoing urinary infection
  • Having only urgency urinary incontinence
  • Using a pacemaker
  • Receiving active cancer treatment (radiotherapy, chemotherapy)
  • Those who have a problem that interferes with cooperation and understanding

结局指标

主要结局

Urinary incontinence severity

时间窗: change from baseline at 4 weeks

Urinary incontinence severity will be assessed with a 1-hour pad test. This amount; less than 2 grams is considered normal, 2-10 grams is mild, 10-50 grams is moderate, and over 50 grams is severe stress urinary incontinence.

次要结局

  • Compliance with Lifestyle Advices(after treatment (4th week))
  • Presence of urinary incontinence symptoms(change from baseline at 4 weeks)
  • Sexual function(change from baseline at 4 weeks)
  • Perception of Subjective Improvement(after treatment (4th week))
  • Life quality(change from baseline at 4 weeks)
  • Patients Satisfaction(after treatment (4th week))

研究者

发起方
Ankara Yildirim Beyazıt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

seyda toprak celenay

associate professor

Ankara Yildirim Beyazıt University

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