Exploring the Role of Sarcopenia and Functional Impairment on the Non-Surgical Management of Urinary Incontinence in Older Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Number of Urinary Incontinence Episodes
研究概览
简要总结
Investigators plan a prospective cohort study with an adaptive design based on physical function status. The design will involve tracking the number of women recruited with physical function impairment and those without any functional impairment. Investigators aim to recruit similar numbers of women in each group. If investigators find unequal numbers, they will adapt recruit strategies based on a woman's functional status.
详细描述
Investigators plan a prospective cohort study with an adaptive design based on physical function status. The design will involve tracking the number of women recruited with physical function impairment and those without any functional impairment. Investigators aim to recruit similar numbers of women in each group. If they find unequal numbers, they will adapt recruit strategies based on a woman's functional status.
Investigators will compare changes in outcome measures within and between groups after 6 and 12 weeks of pelvic floor muscle exercises (PFME). The change in pelvic floor strength/efficiency will be assessed by repeating the pelvic floor PERFECT assessment and will be compared between groups. Changes in UI symptoms, symptom severity, and impact of UI symptoms on quality of life will be determined using standardized measures described above. Data analysis will define associations between changes in PERFECT measures and the change in UI episodes (based on 3-day voiding diary), severity, and type (based on QUID-7), and impact on quality of life (PFIQ-7) within and between groups. Objective measurement of lower-extremity strength will inform the relationship between lower-extremity strength, pelvic floor strength, and UI symptoms at baseline and the 6-week visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women, age 70 years or older
- •Diagnosis of Urinary Incontinence (defined by the QUID assessment as having subscale score for stress ≥4, and/or urge score ≥ 6)
- •Willing and able to be compliant with pelvic floor muscle exercise intervention (standard of care) for 12 weeks and to log compliance
- •Willing and able to undergo an extensive physical function evaluation
排除标准
- •Prior surgical intervention for urinary incontinence within the past 12 months
- •Hysterectomy within 12 months
- •Diagnosis of:
- •Pelvic Organ Prolapse beyond the hymenal ring
- •Urogenital Fistula
- •Neurogenic Overactive Bladder (associated with a diagnosis of Multiple -Sclerosis or Stroke within past 12 months)
- •Incomplete Bladder Emptying/Urinary Retention with PVR >150 ml (measured by bladder scan)
- •Requires assisted device (4 point cane, walker) for ambulation all /most of the time or wheelchair bound
- •Having significant cognitive impairment or dementia
- •Unsafe to exercise (severe cardiopulmonary disease)
- •Unable/unwilling to provide informed consent
- •Determined otherwise ineligible by the principal investigator
结局指标
主要结局
Number of Urinary Incontinence Episodes
时间窗: week 12
Using a three-day voiding diary
次要结局
- Endurance(week 12)
- Repetition of Contractions(week 12)
- Power of Contractions(week 12)
- Number of Fast Contractions(week 12)