跳至主要内容
临床试验/NCT00164138
NCT00164138已完成不适用

Development of an Intervention and and Education Program for Adult Women With Urinary Incontinence and Chronic Lung Disease Including Cystic Fibrosis (CF) and Chronic Obstructive Pulmonary Disease (COPD)

Bayside Health4 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2001年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
99
试验地点
4
主要终点
Symptom measures:

研究概览

简要总结

Women with chronic lung disease characterised by chronic cough report urinary incontinence. Recently there have been reports of increased urinary incontinence in girls and women with cystic fibrosis. While coughing is a known risk factor for stress incontinence, other risk factors and causes are poorly understood in this population. Treatment of incontinence for patients with chronic lung disease is also poorly addressed, adding to the burden of disease for women with chronic lung disease, carers and the health system. This project will estimate the prevalence of women with CF and COPD compared to healthy age matched controls and will evaluate the effect of a specific treatment and management program for these patients. The results will be disseminated to respiratory health professionals. We hypothesise that women with chronic cough will have a higher incidence of urinary incontinence than healthy controls and that a specific treatment program will result in alleviation of the problems and improved quality of life.

详细描述

This project will be undertaken in two phases:

Phase 1 will involve a mailed out screening questionnaire survey of a sample of 50-60 women with CF and 50-60 women with COPD to investigate the prevalence of incontinence in these populations. For subjects requiring assistance an independent physiotherapist is available to assist them with completion of the questionnaire over the telephone. Return stamped addressed envelopes will be provided to each subject in the initial mail-out. The following types of incontinence will be investigated: stress incontinence, urge incontinence, faecal incontinence, faecal urgency, nocturnal enuresis, voiding dysfunction, insensible urine loss, defaecation difficulty, known prolapse, childhood enuresis.

Phase 2 will be an assessment and interventional study. Subjects will be measured before and after the treatment intervention and followed up for three months using the following validated outcome measures:

  • Symptoms measures: 3-day frequency-volume chart, 24-hour pad weigh test, 7-day accident diary, quality of life measure (King's Health Questionnaire).

  • Pelvic floor muscle function:

  • Electromyographic study (EMG) of the pelvic floor muscles using an intravaginal electrode

  • Transabdominal diagnostic ultrasound

  • Adherence to program: self report diary.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Women with CF and COPD

排除标准

  • 未提供

研究组 & 干预措施

Pelvic Floor Training Group

Experimental

Pelvic floor training, biofeedback.

干预措施: Pelvic floor training group (Procedure)

结局指标

主要结局

Symptom measures:

3-day frequency volume chart,

24 hour pad weigh test,

accident diary,

EMG study of the pelvic floor muscles

quality of life using King's Health Questionnaire.

pelvic floor muscle function:

Trans-abdominal diagnostic ultra-sound

次要结局

未报告次要终点

研究者

发起方
Bayside Health
申办方类型
Other Gov
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验