Urinary Incontinence, Mobility & Muscle Function in Older Women: Functional Assessment and Muscle Evaluation Through Exercise (FAME) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Reduction of UI episodes
研究概览
简要总结
The purpose of this study is to decrease rates of urinary incontinence in older women by building strength in the pelvic and lower body muscle through exercise and rehabilitation.
详细描述
This study will provide data on benefits of combination the multimodal strengthening and aerobic conditioning rehabilitation program with pelvic floor muscle training and will help to characterize changes in pelvic floor and lower extremity muscles in older women with urinary incontinence.
The study focuses on a patient-centered approach to improve overall physical function in older women. The study will evaluate the incremental benefit of endurance and lower extremity muscle strengthening in addition to benefits from pelvic floor muscle training. We anticipate that this approach will decrease rates of urinary incontinence because the proposed intervention will focus on prevention of functional decline through endurance, strength, and balance training among older women.
The study will evaluate the pathophysiology of urinary incontinence in older women through evaluation of pelvic floor and lower extremities muscles with an innovative MRI protocol.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women ≥ 65 years older
- •Symptomatic UI
- •Symptoms ≥ 3 months
- •Episodes of UI on 3-day bladder diary
- •Stress, urgency, and mixed UI
排除标准
- •Women unable to have functional assessment and/or complete bladder diary
- •Impaired mental status (MMSE <25)
- •Post-void residual ≥ 150 ml
- •Non-ambulatory (wheelchair bound), unable to complete mobility assessments
- •Urinary tract infection
- •Continuous Incontinence
- •Pelvic Organ prolapse > stage 2
- •Fecal impaction (no BM within 1 week), severe congestive heart failure (leg swelling edema 2+), uncontrolled diabetes (positive urine glucose Dipstick test)
- •Women with significant neurological or musculoskeletal conditions that compromise mobility (stroke, multiple sclerosis, amyotrophic atrophic lateral sclerosis, severe rheumatoid arthritis)
- •Women with contraindications to undergo MRI including claustrophobia.
结局指标
主要结局
Reduction of UI episodes
时间窗: 12 weeks
The primary outcome of this study is reduction in urinary incontinence episodes after multi-modal rehabilitation program compared to standard pelvic floor physical therapy.
次要结局
- muscle strength(12 weeks)
- muscle quality(12 weeks)
研究者
Tatiana Sanses
MD FACOG FPMRS, Associate Professor, Chief, Female Pelvic Medicine & Reconstructive Surgery, Urogynecology
Howard University