Design, Development and Testing of Home-Based Non-Invasive Pelvic Floor Muscle Rehabilitation Device: A Multiphasic Exploratory Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- PFDI (Pelvic floor dysfunction inventory) – 20
研究概览
简要总结
Title: Design, Development and Testing of Home-Based Non-invasive Pelvic Floor Muscle Rehabilitation Device : A Multiphasic Exploratory Study.
Investigator: Ruchi Bhuva PT, Krupa Tank PhD scholar, MPT
Background:
The pelvic floor muscles are crucial for maintaining continence, sexual function, and supporting pelvic organs. These muscles can weaken due to factors like pregnancy, aging, obesity, and certain medical conditions. Weak pelvic floor muscles are associated with issues such as urinary and fecal incontinence, pelvic organ prolapse, sexual dysfunction, and other issues. Low anterior resection syndrome (LARS) affects 80% of patients after rectal cancer surgery. Which include altered bowel frequency, irregular bowel rhythms, fecal incontinence, and constipation. Urinary incontinence (UI) is a common health problem that has been paid more and more attention to all over the world. The most common type was stress UI (SUI). UI afflicts at least 21.6% of the global population. In response to this, a user-friendly, home-based non-invasive biofeedback device could provide a biofeedback for strengthening pelvic floor muscles and improving overall quality of life.
Method: Phase 1 - Designing of device
Phase 2 - Development of device
Phase 3 - Testing of device
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Adults (25 years to 80 years of age group)
- •Patient with pelvic floor dysfunction (urinary
- •incontinence, pelvic organ prolapse, post-prostatectomy incontinence) Male and Female.
排除标准
- •Recent pelvic surgery
- •Pregnancy
- •Severe cognitive impairment.
结局指标
主要结局
PFDI (Pelvic floor dysfunction inventory) – 20
时间窗: Baseline and after 2 weeks.
次要结局
- Quest 2.0(After Completion of Intervention.)
研究者
Ruchi Sanjaykumar Bhuva
School of Physiotherapy, RK University
