Development And Evaluation Of Non – Invasive Biofeedback Device For The Pelvic Floor Muscle Training: An Exploratory Study
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Hitiksha Dedania
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- External observation method
概览
简要总结
The pelvic floor muscles play a critical role in maintaining urinary continence, supporting pelvic viscera, and facilitating sexual function.
Dysfunction or weakness in these muscles can lead to a wide range of health issues, including urinary incontinence, pelvic organ prolapse, and sexual dysfunction. One promising approach to enhance the performance of the pelvic floor muscles is through the use of biofeedback devices. The electromyography (EMG) biofeedback device applied in clinical practice is not preferred by women with urinary incontinence because it is invasive, and involves the insertion of a probe into the vagina, causing pain. This research proposal aims at development of a non-invasive device that can provide feedback regarding the strength of pelvic floor muscles (PFM) contraction of the superficial layer of pelvic floor muscles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 45.00 Year(s) 至 55.00 Year(s)(—)
- 性别
- Female
入选标准
- •Stress urinary incontinence symptoms Moderate symptom distress by the urogenital distress inventory (UDI 6).
- •Mild or moderately severe urinary incontinence as indicated by the (ICIQ-UI SF).
排除标准
- •previous therapy or surgery for urinary incontinence urge incontinence, neurogenic urinary incontinence uncontrolled diabetes neurological abnormalities urinary tract infection previous therapy or surgery for urinary incontinence urge incontinence, neurogenic urinary incontinence uncontrolled diabetes neurological abnormalities urinary tract infection.
结局指标
主要结局
External observation method
时间窗: 0 day 30th day and 60th day
次要结局
- Pelvic floor impact questionnaire (PFIQ – 7)(0 day 30th day and 60th day)
研究者
Hitiksha Rasik Dedania
Parul University, (PhD - Marwadi University)