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临床试验/NCT03862326
NCT03862326已完成不适用

The Effect of Group-, Individual-, and Ultrasound Guided Pelvic Floor Training on Incontinence

University College of Northern Denmark2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2016年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
2
主要终点
Pelvic floor strength

研究概览

简要总结

It will be investigate if women with a diaper grant in Aalborg Municipality can reduce diaper size and thus costs for diapers in the municipality through meetings with a incontinence nurse and pelvic floor exercises.

详细描述

Incontinence is a world wide challenge especially in elderly women. The participation in pelvic floor exercises can to some extent help women with urinary incontinency. In the Municipality of Aalborg in Denmark, the citizens can get a diaper grant, if they are incontinence. The project will be recruiting women with diaper grants and randomly allocate the women to 3 different groups 1) Group training (usual care), 2) Individual training and 3) Individual training with biofeedback in the form of ultrasound. All groups will receive the same incontinence education from the incontinence nurses and physiotherapists. The Women will be offered 6 individual or 10 group base trainings, with increased time between trainings, to increase the participants independency and rely more on home based exercises.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The Investigator and outcome assessor did not know what treatment the indivdual women got.

入排标准

性别
Female
接受健康志愿者

入选标准

  • Diaper grant
  • Urinary incontinency Living in own home in Aalborg Municipality

排除标准

  • Dementia Inability to transport herself to the training facility neurological diseases inability to understand Danish or bring a translator

结局指标

主要结局

Pelvic floor strength

时间窗: Change compared to baseline 3 months after end of intervention.

Change in pelvic floor strength measured through internal palpation with the use of oxford Scale (0-5, where 5 is the highest strength) but transferred to percentage and normalized to baseline values.

次要结局

  • Change in life quality - UDI-6(after 12 weeks of exercise and 3 months follow-up)
  • Change in life quality IIQ-7(after 12 weeks of exercise and 3 months follow-up)

研究者

发起方
University College of Northern Denmark
申办方类型
Other
责任方
Principal Investigator
主要研究者

Signe Refsgaard Bech

Pricipal Investigator

University College of Northern Denmark

研究点 (2)

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