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临床试验/CTRI/2024/12/077558
CTRI/2024/12/077558
尚未招募
不适用

Development And Evaluation Of Non – Invasive Biofeedback Device For The Pelvic Floor Muscle Training: An Exploratory Study

Hitiksha Dedania1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月1日最近更新:

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

发起方
Hitiksha Dedania
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Hitiksha Rasik Dedania

Parul University, (PhD - Marwadi University)

研究点 (1)

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