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

April 12, 2026 updated by: Muhammad Tariq, Lahore University of Biological and Applied Sciences

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 Overview

Status

Active, not recruiting

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Punjab Province
      • Lahore, Punjab Province, Pakistan
        • Lahore University of Biological and Applied Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
This group received diaphragmatic breathing as experimental treatment along with kegel exercises as standard treatment
Patient lies supine with pillow under the head and knees. One hand on abdomen and other on chest Patient inhales deeply through the nose till the chest remains still and hand on the abdomen rises
Other Names:
  • Deep breathing
Patient lies supine with pillow under the head and knees Patient contracts the pelvic floor muscle like holding urine and sustain it for 10-15 seconds
Other Names:
  • Pelvic floor exercises
Active Comparator: Control Group
This group only received kegel exercises as standard treatmeng
Patient lies supine with pillow under the head and knees Patient contracts the pelvic floor muscle like holding urine and sustain it for 10-15 seconds
Other Names:
  • Pelvic floor exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (pre-intervention) and 6 weeks (post-intervention)
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.

Baseline (pre-intervention) and 4 weeks (post-intervention)
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.
Baseline (pre-intervention) and 6 weeks (post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Muhammad Tariq Shafi, Doctor of Physical Therapy, Lahore University of Biological and Applied Sciences
  • Principal Investigator: Maryam Afzal, Doctor of Physical Therapy, Lahore University of Biological and Applied Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2025

Primary Completion (Estimated)

May 5, 2026

Study Completion (Estimated)

May 10, 2026

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

April 12, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 12, 2026

Last Verified

March 1, 2026

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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