Stress Urinary Incontinence (SUI)NCT07537309
Effects of Diaphragmatic Breathing With Kegal Exercises on Pelvic Floor Muscle Function and Quality of Life Among Multigravida Women With Stress Incontinence
A study testing Diaphragmatic Breathing and Kegel exercises in people with Stress Urinary Incontinence (SUI), run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI)
- What is being tested?
- Diaphragmatic Breathing and Kegel exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Sep 2025to 10 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • 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
Who cannot join
- 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)
Show all 9Show fewer
- Women that had chronic pelvic pain
- Women that had any sextual disorders
- Women having any neurological problems
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Lahore University of Biological And Applied Sciences
Lahore, Punjab Province
About this study
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)
- Being tested
- Diaphragmatic Breathing, Kegel exercises
- Keywords
- Pelvic floor muscle, Multigravida, Kegel exercises, Deep breathing, Diaphragmatic breathing
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic BreathingOther
Also called Deep breathing
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
Kegel exercisesOther
Also called Pelvic floor exercises
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | This group received diaphragmatic breathing as experimental treatment along with kegel exercises as standard treatment Receives: Other: Diaphragmatic Breathing; Other: Kegel exercises |
| Control Group | Active comparator | This group only received kegel exercises as standard treatmeng Receives: Other: Kegel exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-intervention) and 6 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start16 Sep 2025
- Primary completion5 May 2026 (estimated)
- Study completion10 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence (SUI)Studies of the same condition, open and under way.
- More trials run by Lahore University of Biological and Applied SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional study model received Diaphragmatic Breathing along with kegel exercises as a standard treatment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Tariq, Lahore University of Biological and Applied Sciences
- Investigators
- Muhammad Tariq Shafi, Doctor of Physical Therapy, Study chair, Lahore University of Biological and Applied SciencesMaryam Afzal, Doctor of Physical Therapy, Principal investigator, Lahore University of Biological and Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537309
- Sponsor's protocol ID
- lcpt,375
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diaphragmatic Breathing With Kegal Exercises on Pelvic Floor Muscle Function and Quality of Life Among Multigravida Women With Stress Incontinence
- ClinicalTrials.gov ID
- NCT07537309
- Acronym / sponsor ID
- lcpt,375
- Conditions
- Stress Urinary Incontinence (SUI)
- Keywords
- Pelvic floor muscle, Multigravida, Kegel exercises, Deep breathing, Diaphragmatic breathing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Lahore University of Biological and Applied SciencesUniversity, hospital or other
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 5 May 2026 (estimated)
- Study completion
- 10 May 2026 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional study model received Diaphragmatic Breathing along with kegel exercises as a standard treatment
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Diaphragmatic Breathing, Other: Kegel exercisesThis group received diaphragmatic breathing as experimental treatment along with kegel exercises as standard treatment |
| Control Group | Active comparator | Other: Kegel exercisesThis group only received kegel exercises as standard treatmeng |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • The population under study was adult women of age between 25-45 years
Key exclusion criteria (9 listed)
- Women with pelvic organ prolapse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragmatic BreathingAlso: Deep breathingPatient 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 | Experimental Group |
| Kegel exercisesAlso: Pelvic floor exercisesPatient 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 | Control Group, Experimental Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
Related trials for Stress Urinary Incontinence (SUI)
Not yet recruiting
Anterior Bridge-Preserving Versus Conventional Early Apical Release in Bipolar Enucleation of the Prostate
Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Active, not recruiting
A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)
Stress Urinary Incontinence (SUI)
Recruiting
Comparing the Effect of Two Types of Pelvic Floor Muscle Stimulation Devices to Improve Symptoms of Urinary Incontinence in Women.
Urinary Incontinence, Mixed Urinary Incontinence
Recruiting
Effect of High-Intensity Focused Electromagnetic (HIFEM) Technology in the Treatment of SUI in Chinese Men Undergone Robotic Radical Prostatectomy
Urinary Incontinence , Stress, Prostatectomy
Recruiting
The Effects of Expiratory Muscle Strength Training in Women With Stress Urinary Incontinence
Stress Urinary Incontinence (SUI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Tariq Shafi, Doctor of Physical Therapy study chair
Lahore University of Biological and Applied Sciences
Maryam Afzal, Doctor of Physical Therapy principal investigator
Lahore University of Biological and Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic Breathing and Kegel exercises in people with Stress Urinary Incontinence (SUI), run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure (time frame: Baseline (pre-intervention) and 6 weeks (post-intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.