跳至主要内容
临床试验/CTRI/2024/11/076341
CTRI/2024/11/076341尚未招募2 期

Effects of education, electrical stimulation and pelvic floor muscle exercise on strength,Quality of Life, Severity in female stress urinary incontinence

M L Ramya Krishna1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2024年12月26日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
82
试验地点
1
主要终点
Perineometer

研究概览

简要总结

Urinary incontinence (UI) is a common condition that affects the quality of life (QoL) of women at different stages of life. To date, about 50% of UI cases are due to stress urinary incontinence (SUI)**.**The  overall  prevalence  of  UI  ranges  from  8-45% in  women  in different studies in india15,16.the prevalence of SUI  in  Indian females with age group of 18-32 was (25.8%)and age group of 33-48was (33.7%)17.Socioeconomic report demonstrates that across all EU countries, the estimated economic burden of UI was €69.1 billion in 202318. Adding Education, Electrical stimulation to PFMT makes any difference in terms of severity, strength, quality of life inconclusive and shows very low quality evidences and there is scarcity of the studies using individual electrical stimulation and Russian currents, and in other studies Russian current prompted to show positive results on muscle strength. Our hypothesis is to find out the effects of Education, Electrical stimulations, Exercises may improve the urinary leakage and pelvic floor muscle strength and QOL.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
30.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • SUI greater than 1 times per week, SUI symptoms, women were asked whether they leaked urine when they coughed, sneezed, laughed, or exercised or with physical exertion, such as lifting something heavy or moving furniture.

排除标准

  • Pregnancy Post menopausal women Previous UI surgery, medications Known malignancy in lower abdomen Impaired bladder or sphincter function Macroscopic haematuria Inter menstrual bleedings Severe psychiatric disorders &Neurological diseases with affection on sensibility in legs or lower limb.

结局指标

主要结局

Perineometer

时间窗: 8th week

Kings health questionnaire

时间窗: 8th week

1 hour pad test

时间窗: 8th week

次要结局

  • BMI(Age)

研究者

发起方
M L Ramya Krishna
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

M L Ramya Krishna

Apollo Institute of Medical Science and Research

研究点 (1)

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