Designing and testing of a novel wearable device for pelvic floor muscle strength in females with stress urinary incontinence: An Exploratory study.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
研究概览
简要总结
Urinary incontinence is an involuntary leakage of urine, which may affect quality of life. Its prevalence is higher after normal delivery and during perimenopause because of pelvic floor muscle weakness. Study involves 44 samples, which will be divided into two groups by lottery method. Group A will receive russian current stimulation with kegels exercise for 4 weeks and group B will receive kegels exercise for 4 week. Primary Outcome measure Pelvic floor muscle strength by perineometer and secondary outcome measure will be taken by Gujarati version of the International Consultation on Incontinence Questionnaire – Urinary Incontinence Short Form (ICIQ UI - SF) score ans Gujarati version of the WHOQOL–BREF scale at 0 day and after completion of 4 weeks. Statistical analysis will be done.
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 and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women aged between 18-75 years Women who report at least three episodes of involuntary urine leakage weekly during the past 3 months Women having Mini-Mental Status Examination (MMSE) score EQUAL OR MORE THAN 24.
排除标准
- •Body mass index more than or equal to 35 kg/m2 Pelvic Organ Prolapse Quantification System (POP-Q) more than Stage 2 History of pelvic surgery or physiotherapy Use of medication for UI or affects skeletal muscle function History of electromagnetic stimulation therapy for Urinary Incontinence Active urinary tract infection An implanted cardiac device or cardiac conditions Neurological diseases Pregnancy.
研究者
ASHIKA TANNA
ASSISTANT PROFESSOR, MARWADI UNIVERSITY