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临床试验/CTRI/2024/09/073662
CTRI/2024/09/073662
已完成
2 期

Design and Development of Sensor Based Pressure Probe and Establishing its Efficacy in the Dosimetry of Kegel Exercises among Females with Urinary Incontinence

Maharishi Markandeshwar University1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2024年10月1日最近更新:

概览

阶段
2 期
状态
已完成
入组人数
230
试验地点
1
主要终点
International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form

概览

简要总结

The study will be designed as a single center study. Participants who will be satisfy the selection criteria will be made part of the study. A sensor-based pressure probe capable of measuring the strength and performance of the pelvic floor muscle will be prepared. The study will be carried on 230 females which will be allocated into 4 groups as Group A, Group B, Group C and Group D that is 58 in each group. Then in each group 58 participants is further divided into intervention group and control group so 29 participants in each group. In all intervention group participants will perform Kegel exercise with sensor based pressure probe whereas in control group participants will perform Kegel exercise through verbal instructions only. The pressure sensor probe will be inserted into vagina allowing the transmission of pressure reading of pelvic floor muscle along with duration of contraction. The inserted probe will be covered with a sterile latex sleeve for each female. So, this present study is aimed to find out the optimal dosage of Kegel exercises in terms of contract- relax time as well as number of repetitions using sensor based pressure probe.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Females suffering from Urinary Incontinence as assessed by International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form Only Married Females.

排除标准

  • Pregnancy Nulliparous Any neurological disorders like multiple sclerosis Muscular dystrophy Refused to perform Kegel exercise Any Urogenital infection Vaginal inflammation Any systemic disorders Any history of trauma to lower abdominal area.

结局指标

主要结局

International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form

时间窗: Two point measurements | On Preintervention Day 1 and On Postintervention day 90

次要结局

  • International Consultation on Incontinence Questionnaire Lower Urinary Tracts Quality of life(Two point measurements)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Arushi Mishra

Department of Physiotherapy

研究点 (1)

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