A Multi-centre Randomised Controlled Trial of a Pelvic Floor Muscle Training Intervention for Women With Pelvic Organ Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 448
- 试验地点
- 49
- 主要终点
- Prolapse symptom score (questions developed in feasibility study and undergoing validation). Primary economic outcome measures are: use of health services, average number of days of prolapse symptoms and further prolapse treatment needed/received
研究概览
简要总结
The aim of this study is to determine the effectiveness and cost-effectiveness of pelvic floor muscle training in the management of pelvic organ prolapse in women.
详细描述
Pelvic organ prolapse is a common problem that adversely affects the daily activities and quality of life of many women. Pelvic floor muscle training interventions are commonly used by physiotherapists to manage prolapse. However, a Cochrane review found limited evidence to support the effectiveness of such interventions. Based on the findings of a successful feasibility study, this multi-centre randomised controlled trial will address the paucity of evidence. 556 symptomatic women with diagnosed prolapse will be enrolled in 16 UK centres and 1 New Zealand centre over 16 months and randomised to pelvic floor muscle training plus lifestyle advice, or to receive a lifestyle leaflet only. Principal measures of outcome are: prolapse symptoms, prolapse severity, and subsequent further treatment up to 12 months after trial entry.
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 (Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •New attendee at outpatient gynaecology clinic
- •Any type of prolapse
排除标准
- •Stage 0 or IV prolapse
- •Women reporting no symptoms of prolapse
- •Previous treatment for prolapse (surgery or formal instruction in Pelvic Floor Muscle Training [PMFT,]unless completed more than 5 years ago, pessary, unless pessary removed more than 12 months ago)
- •Unable to comply with PFMT
- •women who have urogenital atrophy requiring treatment with local oestrogens (after an 8 week course of local oestrogen such women can be included);
- •Pregnant or less than 6 months post-natal
- •Unable to give informed consent
结局指标
主要结局
Prolapse symptom score (questions developed in feasibility study and undergoing validation). Primary economic outcome measures are: use of health services, average number of days of prolapse symptoms and further prolapse treatment needed/received
时间窗: 1 year
次要结局
- Prolapse-related quality of life, prolapse severity, need for further prolapse treatment. Other outcomes include: lifestyle changes, urinary symptoms, bowel symptoms, sexual symptoms, general health status.(1 year)