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临床试验/NCT05236088
NCT05236088Unknown不适用

The Effects of Neuromuscular Electrical Stimulation in Individuals With Urinary Incontinence After Prostatectomy

Ankara Yildirim Beyazıt University0 个研究点目标入组 50 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
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 neuromuscular electric stimulation on urinary symptoms, quality of life, sexual function, perception of improvement and patient satisfaction in individuals with post-prostatectomy urinary incontinence

详细描述

One of the two most common complications after prostatectomy surgeries is urinary incontinence (UI) and the other is erectile dysfunction. There are conservative and surgical treatment options in post-prostatectomy urinary incontinence. One of the conservative treatment options is neuromuscular electrical stimulation application. Since electrical stimulation applications, used in the treatment of post-prostatectomy urinary incontinence, are usually given together with other treatment protocols, there are limitations in clearly demonstrating the effects of neuromuscular electrical stimulation on post-prostatectomy urinary incontinence.

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
Single (Participant)

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 in the urology clinic
  • Being over 40 years old
  • Volunteering to participate in the study

排除标准

  • Severe cardiovascular disease (unstable angina and arrhythmia patients, heart failure patients ect.)
  • Those with sensory loss
  • Presence of ongoing urinary infection
  • Only urgency urinary incontinence
  • Having a pacemaker
  • Active cancer treatment (radiotherapy, chemotherapy),
  • Those who have undergone Transurethral Prostatectomy (TUR-P) surgery
  • 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 assess 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 50 grams is severe stress urinary incontinence.

次要结局

  • Sexual function(change from baseline at 4 weeks)
  • Patient satisfaction(after treatment (4th week))
  • Presence of urinary incontinence symptoms(change from baseline at 4 weeks)
  • Life quality(change from baseline at 4 weeks)
  • Patients' subjective perception of improvement(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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