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临床试验/NCT01032265
NCT01032265已完成不适用

Web-based Management of Female Stress Urinary Incontinence. Evaluation of a Treatment Programme With Pelvic Floor Muscle Training and Elements of Cognitive Behavioural Therapy

Umeå University2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2009年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
2
主要终点
International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)

研究概览

简要总结

The purpose of this study is to determine whether treatment of female stress urinary incontinence using a web-based programme is effective.

详细描述

Female urinary incontinence is very common and affects up to one fourth of grownup women. It may reduce quality of life for those affected and costs for society are high. The most common type of urinary incontinence is stress urinary incontinence (SUI), i.e leakage when coughing, sneezing or jumping. There is no association between SUI and serious medical conditions. Thus investigation can be kept to a minimum, including structured history taking and a bladder diary for correct diagnosis. Treatment with lifestyle intervention and pelvic floor muscle training (PFMT) give improvement or cure in 60-70% of women. A small study indicates that treatment with cognitive behavioural therapy (CBT) may improve incontinence-related quality of life and symptoms of urinary incontinence. Web-based management of SUI has as far as we know never been evaluated in a randomized controlled study. The aim of this study is to determine if web-based management of female SUI, with a treatment using PFMT and elements of CBT is effective compared to treatment supported by a pamphlet. The duration of the treatment programme is three months, follow-up at four months, 1 year and two years.

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
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • stress urinary incontinence
  • leakage once a week or more often
  • ability to read and write Swedish
  • asset to computer with Internet connection

排除标准

  • pregnancy
  • former incontinence surgery
  • known malignancy in lower abdomen
  • difficulties with passing urine
  • visual blood in urine
  • intermenstrual bleeding
  • severe psychiatric diagnosis
  • neurological disease with affection on sensibility in legs or lower abdomen

结局指标

主要结局

International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)

时间窗: baseline, 4 months

condition-specific quality of life, summed score, range 19-76, higher scores indicate greater impact on quality of life.

International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)

时间窗: baseline, 4 months

summed symptom-score, range 0-21, with higher scores indicating greater severity.

次要结局

  • Usage of Incontinence Aids(baseline, 4 months)
  • Patient Satisfaction(4 months)
  • Incontinence Episode Frequency (IEF)(baseline, 4 months)
  • EuroQol Five Dimensions Visual Analogue Scale (EQ5D-VAS)(baseline, 4 months)
  • Patient's Global Impression of Improvement Scale (PGI-I)(4 months)

研究者

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

Eva Samuelsson

Associate professor

Umeå University

研究点 (2)

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