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临床试验/NCT04792125
NCT04792125已完成不适用

The Effects of External Electrical Stimulation Added to Pelvic Floor Muscle Training in Women With Stress Incontinence

Giresun University1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2019年4月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
Self-reported improvement

研究概览

简要总结

In this study, the effects of the external electrical stimulation (EES) added to pelvic floor muscle training (PFMT) on stress urinary incontinence (SUI) were investigated.

详细描述

Fifty one women with mild and moderate SUI symptoms were included in the study. The patients were divided into three groups of PFMT (n:17), EES (n:17) and PFMT+ EES (n:17) by block randomization. The PFMT was applied every day of the week, and EES was applied 3 days a week for 8 weeks. Pelvic floor muscle strength (PFMS), pelvic floor muscle endurance, subjective perception of improvement, severity of incontinence, quality of life, pelvic floor dysfunction (PTD) and urinary parameters were assessed as outcome variables. All measurements, except subjective perception of improvement were investigated before and after treatment.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • having symptoms of pure stress urinary incontinence and stress predominant UI
  • ability to contract pelvic floor muscle strength
  • Having a mild or moderate SUI symptom according to the 24-hour pad test results.

排除标准

  • Pregnancy,
  • Having been treated for incontinence within a period of six months ago,
  • Not being able to cooperate,
  • Presence of urinary infection
  • Use of metal implants or cardiac pacemakers,
  • Epilepsy,
  • Presence of stage 3 or 4 pelvic organ prolapse,
  • Presence of accompanying neurological disease

结局指标

主要结局

Self-reported improvement

时间窗: 8 weeks

Perception of urinary incontinence improvement compared with baseline was assessed using four-item Likert-type scale (worse, same, better, cured).

次要结局

  • 24 hour pad test(8 weeks)
  • pelvic floor muscle strength and endurance(8 weeks)

研究者

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

Ulkukezbansahin

PhD

Giresun University

研究点 (1)

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