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临床试验/NCT01848938
NCT01848938已完成不适用

Treatment of Stress Urinary Incontinence Via Smartphone

Umeå University2 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2013年3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
123
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 stress urinary incontinence (SUI) via smartphone is effective.

详细描述

Female urinary incontinence (UI) 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 SUI, i.e leakage when coughing, sneezing or jumping.

The recommended first line treatment is pelvic floor muscle training (PFMT)which leads to improvement or cure in two-thirds of patients. In addition, life style changes, such as weight loss when obese, smoking cessation and reduction of fluid intake if high is recommended.

There is a need for new , flexible and easily accessible treatment programmes for female urinary incontinence. In our previous study, we compared two treatment programmes for SUI without face-to-face contact: one internet based and one sent by post, both based on three months of PFMT. In this randomized controlled trial of 250 women aged 18-70 years, we found highly significant improvements (p<0.001) with large effect sizes (>0,8)concerning primary outcomes (symptoms and quality of life scores) but no significant differences between groups. Compared with the postal group, more participants in the internet group perceived they were much or very much improved (40.9% vs 26.5%, p<0.01, reported reduced usage of incontinence aids (59.5% vs 41.4%, p=0.02) and were satisfied with the treatment programme (84.8% vs 62.9%, p<0.001).

The selling of smartphones is increasing rapidly. About 75% of all cellphones sold in Sweden today are smartphones. Two million adults in Sweden have a smartphone. Many smartphone owners have at least one health app on their phone. Exercise, diet, and weight apps are the most popular types.

From our previous experience of an Internet-based programme, we have developed a treatment program designed for smartphone. The effect of the treatment programme will be evaluated after three months by comparing the effect in the "smartphone group" with the effect in the "waiting group".

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 —(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
  • duration of symptoms for at least 6 months
  • motivation and time to perform a 12 week long treatment with pelvic floor muscle training
  • ability to read and write Swedish
  • asset to smartphone
  • possibility to send and receive email and asset to printer
  • accept to be randomized to one of two groups; a treatment group or a waiting list group

排除标准

  • participation in our previous internet study
  • 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
  • urge incontinence

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, three months

The instrument includes 19 items on the impact of the leakage. All items are scored 1-4 (not at all/never, slightly/sometimes, moderately/often, a lot/all the time). The overall score is 19-76, with higher values indicating increased impact on QOL.

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

时间窗: baseline, three months

Three items on frequency, amount of leakage and overall impact. Scoring 0-21, higher values indicating increasing severity

次要结局

  • Patient's Global Impression of Improvement Scale (PGI-I)(three months)
  • Usage of Incontinence Aids(three months)
  • Patient Satisfaction(three months)
  • Incontinence Episode Frequency (IEF)(baseline, three months)

研究者

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

Eva Samuelsson

Associate professor, General Practitioner

Umeå University

研究点 (2)

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