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Clinical Trials/NCT07537309
NCT07537309
Active, not recruiting
Not Applicable

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 site in 1 country84 target enrollmentStarted: September 16, 2025Last updated:

Overview

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Lahore University of Biological and Applied Sciences
Enrollment
84
Locations
1
Primary Endpoint
Pressure

Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
25 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • • 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

Exclusion Criteria

  • 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

Arms & Interventions

Experimental Group

Experimental

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

Intervention: Kegel exercises (Other)

Control Group

Active Comparator

This group only received kegel exercises as standard treatmeng

Intervention: Kegel exercises (Other)

Experimental Group

Experimental

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

Intervention: Diaphragmatic Breathing (Other)

Outcomes

Primary Outcomes

Pressure

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Lahore University of Biological and Applied Sciences
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Muhammad Tariq

Assistant professor

Lahore University of Biological and Applied Sciences

Study Sites (1)

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