Web-based Management of Female Stress Urinary Incontinence. Evaluation of a Treatment Programme With Pelvic Floor Muscle Training and Elements of Cognitive Behavioural Therapy
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
- 否
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
Eva Samuelsson
Associate professor
Umeå University
