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临床试验/NCT05239949
NCT05239949已完成不适用

Effects of Hypopressive Exercises in Comparison With Routine Pelvic Floor Exercises in Women With Urinary Incontinence: A Randomized Controlled Trial

Riphah International University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Medical, Epidemiologic and Social aspects of Aging Questionnaire (MESA Questionnaire)

研究概览

简要总结

The aim of our study is to compare the effects of hypopressive exercises with routine pelvic floor exercises in improving the frequency and severity of urinary incontinence in women and also to enhance their quality of life as it worsens after childbirth, pregnancy, and in older age.

详细描述

A randomized control trial study will be conducted in which patients with urinary incontinence will be assigned to group 1 that will receive hypopressive exercises with electrical muscle stimulation (EMS) and patients in group 2 will receive pelvic floor exercises with EMS.

The intervention will be applied (3 days/week) for 8 weeks. Four sets of 10 repetitions with a 3-minute interval between each set will be performed for group 1 in an upright position while four sets of 10 repetitions with a 2-minute interval between each set will be performed for group 2 in the sitting position.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

our study will be single-blinded, outcome assessor will be blinded to avoid being biased during outcome assessment.

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged between 20 to 65 years
  • Gynecologist and urologist diagnosed patients
  • Participants not engaged systematically in sports or physical activities(≤ sessions per week, ≤ weeks per week)

排除标准

  • If participants had hypertension or any serious mental disease
  • Pregnancy or up to 2 months postpartum
  • Urge fecal incontinence or vaginal pain
  • Underwent any physiotherapy for urinary incontinence before
  • Any kidney disease

结局指标

主要结局

Medical, Epidemiologic and Social aspects of Aging Questionnaire (MESA Questionnaire)

时间窗: 8th week

It is a reliable and validated tool to evaluate the severity and predominance of stress and urge urinary incontinence. The MESA Questionnaire consists of 15 items total divided into stress (1-9) and urge (10-15) subscales. The total score of urgency (18) and stress (27) is divided into three degrees. For urgency, a score of 1-6 is categorized as mild, 7-12 moderate, and 13-18 as severe. For stress, a score of 1-9 is categorized as mild, 10-18 moderate, and 19-27 as severe. A higher MESA score indicates more frequent symptoms overall ranges from 0-45.

International Consultation Incontinence Questionnaire Short Form (ICIQ-SF)

时间窗: 8th week

ICIQ-SF is a screening tool for incontinence. 4 main items (a total of 6) ask for a rating of symptoms in past four weeks. Item 1 and 2 are demographics so items 3,4,5 are summed for a total score. Using a score value, UI is classified as mild (1-5), moderate (6-12), severe (13-18), very severe (19-21) from a total score ranges from 0-21.

International Impact Questionnaire, Short Form (IIQ-7)

时间窗: 8th week

IIQ-7 is a reliable tool for measuring the impact on quality of life for UI patients. Calculate the mean of all items and then subtract the mean by 1, then multiply by 100/3 (0-100 range).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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