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临床试验/CTRI/2023/03/050779
CTRI/2023/03/050779已完成不适用

“Effectiveness of hip muscles strengthening with kegels exercise in treatment of stress urinary incontinence among postmenopausal women: A Randomized Controlled Trial’’

MGM INSTITUTE OF PHYSIOTHERAPY1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年1月4日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Symptom and QoL Evaluation

研究概览

简要总结

Objectives

1.     To determine the effectiveness of kegel’s exercises on frequency, strength and QOL in stress urinary incontinence among postmenopausal women

2.     To determine the effectiveness of kegel’s exercises combined with hip muscles strengthening on frequency, strength and QOL in treatment of stress urinary incontinence among postmenopausal women

  1. To compare the effectiveness of hip muscles strengthening on frequency, strength and QOL in treatment of stress urinary incontinence among postmenopausal women

Study design: Randomized Control Trial

Study setting: Tertiary Hospitals, Outreach Programs, PHC

Procedure:  Female patients with stress urinary incontinence in the age of 45-70 years of age will be taken. Eligible participants will be included for the study. Before collection of the data, Informed written and verbal consent will be taken from all the participants. The subjects will be interviewed and the information gathered about their demographic data of patients including name, age, gender, occupation, any history of systemic diseases and medications will be documented. Demographic data will be collected and 2 evaluations carried out, 1 at the beginning of the treatment and the other after 16 sessions of physical therapy intervention. Also after 1month till 20th session, follow up will be taken.

Conventional Treatment Group:

Participants will be given Kegel’s only in Group A.

Intervention Group

Participants will be given Hip muscles strengthening along with Kegel’s in Group B. The same exercises as those described for the conventional treatment group (Kegels exercises) will be performed during the first 20 minutes. After that, the KHG group will perform exercises for strengthening hip adductor, gluteus medius and maximus muscles for approximately 20 minutes, completing 40 minutes of session. The exercises for the hip muscles will be completely isolated from the Kegels exercises and will follow a protocol based on recommendations by the American College of Sports Medicine, with adjustments made to suit the profile of the women in this study.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
45.00 Year(s) 至 70.00 Year(s)(—)
性别
Female

入选标准

  • 1.Female patients with medical diagnosis of stress urinary incontinence among postmenopausal women 2.LMP atleast 12months ago.

排除标准

  • 1.Anti-incontinence or pelvic organ prolapse surgery history 2.Active urinary tract or vaginal infection, 3.Post-partum incontinence issues till 1 year 4.Pregnancy, post-void residual volume>100 ml 5.Pelvic organ prolapse>Grade 2, 6.Presence of comorbidities that affect the lower urinary tract, such as neurological disease, diabetes mellitus, psychiatric disease or renal failure.
  • 7.Current hormone replacement therapy.

结局指标

主要结局

Symptom and QoL Evaluation

时间窗: 10 mins

次要结局

  • Evaluation of Pelvic Floor Function and Muscle Strength:(10mins)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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