Physiotherapy for Stress Urinary Incontinence: Feasibility Study for a Randomized Controlled Trial of Hip External Rotation Exercise Training Versus Pelvic Floor Muscle Exercise Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Feasibility: achieve follow-up for 60% of recruits over 12 months
研究概览
简要总结
This RCT is a feasibility study to evaluate the Lois Hole Hospital for Women's Urogynecology Clinic's ability to recruit and randomize SUI patients to the proposed RCT, and to test the study procedures and follow-up schedule for participants.
The study interventions used in the feasibility study will be training of (1) Hip Extension Rotation (HER) exercises alone, (2) HER exercises in combination with Pelvic Floor Muscle (PFM) exercises, or (3) PFM exercises alone (control/usual care) in the treatment of SUI.
详细描述
Background: Hip External Rotation (HER) exercises are being adopted into physiotherapy practice for the treatment of stress urinary incontinence (SUI) despite little evidence compared to the proven effective standard of care treatment, pelvic floor muscle (PFM) exercises. A randomised clinical trial (RCT) is needed to determine whether HER exercise alone or in combination with PFM is more or less effective than PFM exercises alone.
Objective: Before designing an RCT, a feasibility study is needed to evaluate the Lois Hole Hospital for Women's Urogynecology Clinic's ability to recruit and randomize SUI patients to the proposed RCT, and to test the study procedures and follow-up schedule for participants.
Interventions: The interventions used in the feasibility study will be training of (1) HER exercises alone, (2) HER exercises in combination with PFM exercises, or (3) PFM exercises alone (control/usual care) in the treatment of SUI.
Study design: RCT in which participants are randomly allocated 1:1:1 to each intervention.
Outcome Measures: Feasibility outcomes will pertain to recruitment, adherence to training, appropriateness of outcome measures and completion rates. The design of the proposed RCT will be based on these feasibility outcomes.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Patient and research assistant are blind to next allocation. Outcome assessors (physiotherapist and exercise physiologist) and one investigator are blinded to group of allocation. Statistician will be masked to group of allocation.
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
- •Stress urinary incontinence
- •Attending Lois Hole Hospital for Women Urogynecology Clinic
- •Referred for physiotherapy for stress urinary incontinence
- •Able to toilet independently
- •Able to undertake hip rotation exercises
- •Able to speak and read English
排除标准
- •Urge urinary incontinence
- •Using a pessary
- •Neurological or cognitive impairment
- •Using other treatment for incontinence
- •Unable to complete study forms
- •Unable to understand educational instruction
结局指标
主要结局
Feasibility: achieve follow-up for 60% of recruits over 12 months
时间窗: 12 months
Is follow-up complete for 60% of recruits?
Feasibility: achieve recruitment of 30 women over 12 months
时间窗: 12 months
Is recruitment feasible? "Feasibility" is defined as achieving recruitment target of 30 recruits within 12 months
次要结局
- Diary-reported urinary incontinence(12 & 24 weeks)
- Patient mobility(12 & 24 weeks)
- Pelvic floor muscle strength(12 & 24 weeks)
- Incontinence-related quality of life (distress)(12 & 24 weeks)
- Incontinence-related quality of life (impact)(12 & 24 weeks)
- External hip rotator muscle strength(12 & 24 weeks)
- Patient mobility (walking)(12 & 24 weeks)