A Multicentre Randomised Controlled Trial of Pelvic Floor Muscle Training to Prevent Pelvic Organ Prolapse in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 337
- 试验地点
- 3
- 主要终点
- Pelvic organ prolapse symptom score (POP-SS)
研究概览
简要总结
Pelvic organ prolapse is a problem experienced by women where a bulge comes down in the vagina, and may even drop down outside the vagina. The bulge in the vagina is caused by other organs moving down from their normal position in the pelvis and pushing into the vagina. This is a very common problem and many women who have given birth will have a very mild bulge which does not cause them symptoms. Women can however experience a variety of pelvic, bladder, bowel and sexual symptoms which impact on daily life. No research studies have properly examined whether or not exercises can prevent prolapse. This study aims to explore whether exercises taught by a physiotherapist can prevent women developing a prolapse which requires them to have treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women involved in the ProLong study who:
- •have some evidence of vaginal laxity in any compartment (POP-Q stage I, II or III)
- •have had no previous treatment for prolapse (surgery, pessary, PFMT)
- •Women must be willing to participate in the Trial and to comply with their group allocation.
排除标准
- •with stage 0 or IV prolapse
- •who have had previous incontinence surgery (except mid-urethral sling operation)
- •who have had previous formal instruction in PFMT for any diagnosis in preceding five years
- •who are pregnant, or delivered a baby within the last six months
- •who are unable to comply with PFMT treatment
- •who are unable to give informed consent
研究组 & 干预措施
Physiotherapy
干预措施: Pelvic Floor Muscle training (Other)
Control
Women allocated to the Control group will only receive, by post, the same Lifestyle Advice Sheet as the intervention group.
结局指标
主要结局
Pelvic organ prolapse symptom score (POP-SS)
时间窗: 4 years post randomisation
A summation of responses to seven prolapse symptom questions (range 0-28)
Pelvic organ prolapse symptom score (POP-SS)
时间窗: Baseline (prior to randomisation)
A summation of responses to seven prolapse symptom questions (range 0-28)
Pelvic organ prolapse symptom score (POP-SS)
时间窗: 1 Year post randomisation
A summation of responses to seven prolapse symptom questions (range 0-28)
Pelvic organ prolapse symptom score (POP-SS)
时间窗: 2 years post randomisation
A summation of responses to seven prolapse symptom questions (range 0-28)
Pelvic organ prolapse symptom score (POP-SS)
时间窗: 3 years post randomisation
A summation of responses to seven prolapse symptom questions (range 0-28)
次要结局
- Need for prolapse treatment(4 years post randomisation)
- The average number of days of prolapse symptoms(4 years post randomisation)
- Prolapse-related quality of life(4 years post of randomisation)
- Prolapse severity(Four years post randomisation)
- Lifestyle changes(4 years post randomisation)
- Urinary symptoms(4 years post randomisation)
- Bowel symptoms(4 years post randomisation)
- Sexual symptoms(4 years post randomisation)
- General health status(4 years post randomisation)
- Need for prolapse treatment(1 year post randomisation)
- Prolapse-related quality of life(Baseline (prior to randomisation))
- Lifestyle changes(1 year post randomisation)
- Urinary symptoms(Baseline (prior to randomisation))
- Bowel symptoms(Baseline (prior to randomisation))
- Sexual symptoms(Baseline (prior to randomisation))
- General health status(Baseline (prior to randomisation))
- The average number of days of prolapse symptoms(Baseline (prior to randomisation))
- Prolapse-related quality of life(1 year post randomisation)
- Prolapse-related quality of life(2 years post randomisation)
- Prolapse-related quality of life(3 years post randomisation)
- Lifestyle changes(2 years post randomisation)
- Lifestyle changes(3 years post randomisation)
- Need for prolapse treatment(2 years post randomisation)
- Urinary symptoms(1 year post randomisation)
- Urinary symptoms(2 years post randomisation)
- Urinary symptoms(3 years post randomisation)
- Bowel symptoms(1 year post randomisation)
- Bowel symptoms(2 years post randomisation)
- Bowel symptoms(3 years post randomisation)
- Sexual symptoms(1 year post randomisation)
- Sexual symptoms(2 years post randomisation)
- Sexual symptoms(3 years post randomisation)
- General health status(1 year post randomisation)
- General health status(2 years post randomisation)
- General health status(3 years post randomisation)
- Need for prolapse treatment(3 years post randomisation)
- The average number of days of prolapse symptoms(1 year post randomisation)
- The average number of days of prolapse symptoms(2 years post randomisation)
- The average number of days of prolapse symptoms(3 years post randomisation)
研究者
Ms Suzanne Hagen
Programme Director
Glasgow Caledonian University