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

NCT07537309 | Active Not Recruiting

• 1 other identifier: lcpt,375
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Conditions

Stress Urinary Incontinence (SUI)

Keywords

Pelvic floor muscle; Multigravida; Kegel exercises; Deep breathing; Diaphragmatic breathing

Outcome Measures

Primary Outcomes (3)

• Pressure

  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

  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

  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)

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Other: Diaphragmatic Breathing; Other: Kegel exercises

Control Group

ACTIVE COMPARATOR

This group only received kegel exercises as standard treatmeng

Other: Kegel exercises

Interventions

Diaphragmatic Breathing OTHER

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

Also known as: Deep breathing

Experimental Group

Kegel exercises OTHER

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

Also known as: Pelvic floor exercises

Control Group; Experimental Group

Eligibility Criteria

• Age: 25 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lahore University of Biological and Applied Sciences: lead

Study Sites (1)

Lahore University of Biological And Applied Sciences

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Muhammad Tariq Shafi, Doctor of Physical Therapy

  Lahore University of Biological and Applied Sciences

  STUDY CHAIR

• Maryam Afzal, Doctor of Physical Therapy

  Lahore University of Biological and Applied Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Interventional study model received Diaphragmatic Breathing along with kegel exercises as a standard treatment

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 17, 2026
• Study Start: September 16, 2025
• Primary Completion: May 5, 2026
• Study Completion (Estimated): May 10, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-03

Locations

PA (1)