- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07537309
Effects of Diaphragmatic Breathing With Kegal Exercises on Pelvic Floor Muscle Function and Quality of Life Among Multigravida Women With Stress Incontinence
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan
- Lahore University of Biological and Applied Sciences
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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:
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:
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|
Active Comparator: Control Group
This group only received kegel exercises as standard treatmeng
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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:
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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.
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Baseline (pre-intervention) and 6 weeks (post-intervention)
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Endurance
Time Frame: Baseline (pre-intervention) and 4 weeks (post-intervention)
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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)
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Incontinence Quality of Life
Time Frame: Baseline (pre-intervention) and 6 weeks (post-intervention)
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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.
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Baseline (pre-intervention) and 6 weeks (post-intervention)
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Collaborators and Investigators
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
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Incontinence
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Urinary Incontinence, Stress
Other Study ID Numbers
- lcpt,375
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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