UriCO - Effect of Pelvic Floor Muscle Training and Cough-suppression Therapy on Urinary Incontinence Amongst Women With Chronic Obstructive Pulmonary Disease; a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- International Consultation on Incontinence Questionnaire Short form (ICIQ_SF)
研究概览
简要总结
The primary aim of the study is to investigate whether pelvic floor muscle training or cough-suppression therapy reduces symptoms of urinary incontinence amongst women with chronic obstructive pulmonary disease grade 1-4 (mild to very severe disease).
详细描述
This two-centre study will consist of a randomised controlled trial (RCT) with a parallel group design and include two intervention groups and one control group. Recruitment and data collection will occur simultaneously at the ØHT and St. Olav's Hospital in Trondheim.
All participants will complete an initial four week general group exercise class (1 hour once a week) prior to randomisation. This intervention will focus on strength exercises (lower limb and upper limb), endurance training, balance training and thorax mobilising exercises. All participants will be examined and complete questionnaires at two occasions; after the initial four weeks general exercise/before intervention, and at 16 weeks post-randomisation.
Participants will be randomised to either Intervention group A (pelvic floor muscle training group), Intervention group B (cough-suppression group) or a control group who will receive brief written information about pelvic floor muscle training and cough-suppression, but no other form of regular follow-up or intervention throughout the intervention period.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •COPD grade 1-4
- •Subjective urinary incontinence
- •Ability to perform an active contraction of the pelvic floor muscles
排除标准
- •Unstable COPD
- •More than 4 hospital admissions due to COPD in the past twelve months
- •Neurological conditions
- •Previous gynecological surgery
研究组 & 干预措施
Pelvic floor muscle training
Participants in the pelvic floor muscle training group will receive group exercise sessions (1 hour) at the physiotherapy out-patient department of the hospital once a week for 16 weeks with guidance from an experienced pelvic floor physiotherapist. The group exercise sessions will focus on pelvic floor muscle training, relaxation and breathing techniques. Participants in the pelvic floor muscle training group will also receive an individually adapted pelvic floor muscle training program for daily home use.
干预措施: Pelvic floor muscle training (Procedure)
Cough-suppression
Participants in the cough-suppression group will receive a group education session with general information about cough-suppression therapy and advice about how to distinguish between unproductive and productive cough to enable them to perform airway clearance techniques when required. In addition, participants will receive one to two individual sessions (30-60 minutes) of cough-suppression therapy tailored to the individual needs based on symptoms and underlying disease activity
干预措施: Cough-suppression therapy (Procedure)
Control group
Participants in the group will receive guidance and instruction in terms of correct contraction of the pelvic floor muscles at clinical assessment. Control group participants will receive brief written information about pelvic floor muscle training and cough-suppression therapy, but no other form of regular follow-up or intervention throughout the intervention period.
干预措施: Control (Other)
结局指标
主要结局
International Consultation on Incontinence Questionnaire Short form (ICIQ_SF)
时间窗: Change from baseline score at 16 weeks
Participants in the group will receive guidance and instruction in terms of correct contraction of the pelvic floor muscles at clinical assessment. Control group participants will receive brief written information about pelvic floor muscle training and cough-suppression therapy, but no other form of regular follow-up or intervention throughout the intervention period.
次要结局
- Chronic Obstructive Pulmonary Disease symptoms(Change from baseline score at 16 weeks)
- Self-reported function and quality of life(Change from baseline score at 16 weeks)
- Voluntary pelvic floor muscle function(Change from baseline score at 16 weeks)
- Cough symptoms(Change from baseline score at 16 weeks)
- Pelvic floor muscle strength(Change from baseline score at 16 weeks)
- Field walking test(Change from baseline score at 16 weeks)
- Physical activity(Change from baseline score at 16 weeks)
研究者
Stacey Haukeland Parker
MSc/senior physiotherapist
Ostfold Hospital Trust