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临床试验/NCT07537309
NCT07537309进行中(未招募)不适用

Effects of Diaphragmatic Breathing With Kegal Exercises on Pelvic Floor Muscle Function and Quality of Life Among Multigravida Women With Stress Incontinence

Lahore University of Biological and Applied Sciences1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年9月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
84
试验地点
1
主要终点
Pressure

研究概览

简要总结

The goal of this clinical trial is to determine the effect of diaphragmatic breathing with kegel exercises on pelvic floor muscle function and quality of life among multigravida women with stress urinary incontinence The main question it aims to answer are The effect of diaphragmatic breathing in combination with Kegel exercises is significant in improving pelvic floor muscle function and quality of life among multigravida women with stress urinary incontinence.

The researcher will compare diaphragmatic breathing to kegel exercises as a standard treatment to see if it produces better results for treating SUI Participants will Perform diaphragmatic breathing with kegel exercises for 6 weeks Visit clinic every at the end of every week They will keep a diary regarding when they performed exercises

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • • The population under study was adult women of age between 25-45 years
  • Women with the history of at least two parities
  • No previous history of undergoing any physical therapy treatment for SUI
  • The study included clinically diagnosed women with stress urinary incontinence
  • Study included grade 1-2 severity of SUI that can be treated conservatively
  • Women with both vaginal and c-section deliveries were included

排除标准

  • Women with pelvic organ prolapse
  • Women that were menopausal or post-menopausal
  • Pregnant women and 6 months post-partum
  • Any other surgical and medical history (congenital urological disease or tumor of bladder)
  • Women with detrusor hyperreflexia
  • Any on-going Infection (vaginal lesion or UTI)
  • Women that had chronic pelvic pain
  • Women that had any sextual disorders
  • Women having any neurological problems

研究组 & 干预措施

Experimental Group

Experimental

This group received diaphragmatic breathing as experimental treatment along with kegel exercises as standard treatment

干预措施: Kegel exercises (Other)

Control Group

Active Comparator

This group only received kegel exercises as standard treatmeng

干预措施: Kegel exercises (Other)

Experimental Group

Experimental

This group received diaphragmatic breathing as experimental treatment along with kegel exercises as standard treatment

干预措施: Diaphragmatic Breathing (Other)

结局指标

主要结局

Pressure

时间窗: Baseline (pre-intervention) and 6 weeks (post-intervention)

a biofeedback device with vaginal probes was used to Measure pelvic floor muscle strength The probe connected to the biofeedback was inserted into the vagina and 55mm of Hg pressure was maintained by inflating the probe through the biofeedback. Strength was assessed by recording the maximum pressure exerted during the voluntary pelvic floor muscle contraction on command. Pressure was recorded in mm of Hg by the device. According to a research manometry results measured in cm H2O unit was categorized according to the modified oxford scale into 0-5 grading scales. 0 indication none and 5 indicating strong contraction to categorize the collected data.

Endurance

时间窗: Baseline (pre-intervention) and 4 weeks (post-intervention)

A biofeedback device with vaginal probe was used to measure the endurance of pelvic floor muscles. The probe connected to the biofeedback was inserted into the vagina and 55mm of Hg pressure was maintained by inflating the probe through the biofeedback. Endurance was measured by recording the number of seconds a contraction was sustained over a period of 10 seconds. Pressure was recorded in number of seconds, 0 indication none and 10 indicating excellent endurance to categorize the collected data.

Incontinence Quality of Life

时间窗: Baseline (pre-intervention) and 6 weeks (post-intervention)

Quality of life of patients suffering from Urinary Incontinence was measured using a questionnaire. The I-QOL questionnaire is based on 6 points scale ranging from 0 = none to 5= very great deal including 22 items. The questionnaire evaluates social life impacts, social embarrassment, psychological impacts and avoiding and limiting behavior associated with urinary incontinence. Total score was calculated using the formula: total score= (obtained sum by total items/110) x 100%. A low score indicated poor quality of life whereas a higher score indicated good quality of life among the patients of SUI. This questionnaire is used worldwide and is highly reliable and valid.

次要结局

未报告次要终点

研究者

发起方
Lahore University of Biological and Applied Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammad Tariq

Assistant professor

Lahore University of Biological and Applied Sciences

研究点 (1)

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