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临床试验/CTRI/2024/09/073809
CTRI/2024/09/073809尚未招募3 期

Design, Development and Testing of Home-Based Non-Invasive Pelvic Floor Muscle Rehabilitation Device: A Multiphasic Exploratory Study

Ruchi Sanjaykumar Bhuva1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月2日最近更新:

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

发起方
Ruchi Sanjaykumar Bhuva
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Ruchi Sanjaykumar Bhuva

School of Physiotherapy, RK University

研究点 (1)

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