Stress Urinary Incontinence (SUI)SUI PFMT HENCT07322328
Effect of Hypo-pressive Exercises and Pelvic Floor Muscle Training in Postpartum Stress Urinary Incontinence Women
A study testing hypo-pressive exercise and pelvic floor muscle training in people with Stress Urinary Incontinence (SUI) and Stress Urinary Incontinence in Women, run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.
Trial summary
Postpartum stress urinary incontinence is a widespread condition characterized by involuntary loss of urine during physical exertion, such as sneezing, coughing, or lifting heavy weights. Most frequently occur in multiparous women with vaginal delivery, who are obese, constipated, or with low maternal education. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI), Stress Urinary Incontinence in Women
- What is being tested?
- hypo-pressive exercise and pelvic floor muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Dec 2025to 22 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged between 20 and 40 years old
- Multiparous women
- Postpartum women ≤ 6 months.
- Vaginal deliveries.
- Women diagnosed with stress urinary incontinence within 6 weeks to six months
Who cannot join
- Neurological disorder
- Metabolic issue
- Abdominal and pelvic surgery in previous years
- Mentally retarded
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Lahore University of Biological and Applied Sciences
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Hypo-pressive Exercises and Pelvic Floor Muscle Training on the Severity of Stress Urinary Incontinence and Quality of Life in Postpartum Women
Postpartum stress urinary incontinence is a widespread condition characterized by involuntary loss of urine during physical exertion, such as sneezing, coughing, or lifting heavy weights. Most frequently occur in multiparous women with vaginal delivery, who are obese, constipated, or with low maternal education. Damage to the levator ani muscle complex and adjacent fascia during childbirth affects urethral mobility and consequently results in sphincter insufficiency.
Hypopressive exercises involve breathing techniques that regulate the intra-abdominal pressure. HE has been recently recognized for benefits such as pelvic floor muscle (PFM) strength, endurance, postural control, core muscle activation, and respiratory capacity, which efficiently improve symptom severity and quality of life in postpartum women.
Read more
Pelvic floor muscle training (PFMT) is a set of frequent voluntary contractions designed to improve strength, coordination, and control. PFMT is considered as standard treatment protocol for urinary incontinence and other postpartum complications.
The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI-SF) and the Incontinence Quality of Life (IQOL) are used to assess symptom severity and quality of life, respectively. This study seeks to bridge that gap by evaluating and comparing the outcomes of HE and PFMT in postpartum women experiencing SUI. This research aims to support postpartum recovery, improve women's daily functioning, and enhance their overall well-being.
- Being tested
- hypo-pressive exercise, pelvic floor muscle training
- Keywords
- Post-partum stress urinary incontinence, Hypopressive exercises, Pelvic floor muscle training, Quality of life
- 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.
hypo-pressive exerciseOther
Exercise is performed 3 times per week for 6 weeks with moderate intensity for 20 min/session which includes diaphragmatic breathing, apnea, postural alignment (standing, seated, kneeling), and pelvic floor co-activation).
pelvic floor muscle trainingOther
Exercise is performed 3 times per week for 6 weeks with submaximal voluntary contraction (include both slow holds and quick flicks) for 20 min/session (each session includes multiple sets of 8 repetitions, hold for 5 seconds, with rest intervals). These Kegel exercises are performed in different positions.
| Study group | Role | What they receive |
|---|---|---|
| Hypopressive Exercises | Experimental | Hypo-pressive Exercise (HE) training involves ribcage expansion and apnea to generate negative pressure, which in turn activates the deep core and pelvic floor muscles instinctively. Activating type I muscle fibers improves postural control, endurance, and coordination. Receives: Other: hypo-pressive exercise |
| Pelvic Floor Muscle Training | Active comparator | Pelvic Floor Muscle Training (PFMT) through voluntary contraction and resistance training strengthens pelvic floor musculature. In addition, these exercises have the potential to improve control over urine and fecal incontinence. Receives: Other: pelvic floor muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms severity
Symptom severity due to SUI will assessed by International Consultation on Incontinence Questionnaire Urinary Incontinence short form (ICIQUI-SF) is a standardized, validated, self-administered questionnaire used to assess the severity of urinary incontinence (UI), influence quality of life, and situational triggers of leakage. It consists of four items: frequency of urine leakage, amount of urine leakage, overall impact of UI on daily life (rated on a 0-10 scale), and a self-diagnostic item asking when urine leaks (non-scored). The ICIQ-UI-SF showed a Cronbach's alpha value from 0.7 to 0.8, representing good internal consistency
Measured: 6 weeks
Secondary outcomes (1)
Incontinence Quality of life
Incontinence Quality of life (I-QOL) is a self-assessment tool that is repeatedly utilized in people with UI. The 22-item I-QOL has three subscales: social embarrassment (SE), psychosocial impact (PSI), and avoidance and limiting behaviors (ALB). It based on Likert scale which comprises of five point, i.e. 1=always, 2=often, 3=sometimes, 4=rarely and 5=never. The IQOL showed a Cronbach's alpha value was 0.96, representing good internal consistency.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start22 Dec 2025
- Primary completion22 May 2026
- Study completion22 May 2026
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mehwish Khalid, Lahore University of Biological and Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322328
- Sponsor's protocol ID
- DPT/ERB/29
- Other IDs
- U1111-1332-3272
- Acronym
- SUI PFMT HE
- Status last verified
- Aug 2026
- First submitted
- 22 Dec 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the publication of the research
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hypo-pressive Exercises and Pelvic Floor Muscle Training on the Severity of Stress Urinary Incontinence and Quality of Life in Postpartum Women
- ClinicalTrials.gov ID
- NCT07322328
- Acronym / sponsor ID
- SUI PFMT HE / DPT/ERB/29
- Keywords
- Post-partum stress urinary incontinence, Hypopressive exercises, Pelvic floor muscle training, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Lahore University of Biological and Applied SciencesUniversity, hospital or other
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- 22 May 2026 (actual)
- First posted
- 7 Jan 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.
Postpartum stress urinary incontinence is a widespread condition characterized by involuntary loss of urine during physical exertion, such as sneezing, coughing, or lifting heavy weights. Most frequently occur in multiparous women with vaginal delivery, who are obese, constipated, or with low maternal education. Damage to the levator ani muscle complex and adjacent fascia during childbirth affects urethral mobility and consequently results in sphincter insufficiency.
Hypopressive exercises involve breathing techniques that regulate the intra-abdominal pressure. HE has been recently recognized for benefits such as pelvic floor muscle (PFM) strength, endurance, postural control, core muscle activation, and respiratory capacity, which efficiently improve symptom severity and quality of life in postpartum women.
Pelvic floor muscle training (PFMT) is a set of frequent voluntary contractions designed to improve strength, coordination, and control. PFMT is considered as standard treatment protocol for urinary incontinence and other postpartum complications.
The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI-SF) and the Incontinence Quality of Life (IQOL) are used to assess symptom severity and quality of life, respectively. This study seeks to bridge that gap by evaluating and comparing the outcomes of HE and PFMT in postpartum women experiencing SUI. This research aims to support postpartum recovery, improve women's daily functioning, and enhance their overall well-being.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypopressive Exercises | Experimental | Other: hypo-pressive exerciseHypo-pressive Exercise (HE) training involves ribcage expansion and apnea to generate negative pressure, which in turn activates the deep core and pelvic floor muscles instinctively. Activating type I muscle fibers improves postural control, endurance, and coordination. |
| Pelvic Floor Muscle Training | Active comparator | Other: pelvic floor muscle trainingPelvic Floor Muscle Training (PFMT) through voluntary contraction and resistance training strengthens pelvic floor musculature. In addition, these exercises have the potential to improve control over urine and fecal incontinence. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged between 20 and 40 years old
- Multiparous women
- Postpartum women ≤ 6 months.
- Vaginal deliveries.
- Women diagnosed with stress urinary incontinence within 6 weeks to six months
Key exclusion criteria (5 listed)
- Neurological disorder
- Metabolic issue
- Abdominal and pelvic surgery in previous years
- Mentally retarded
- Pregnant women
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 |
|---|---|---|
| hypo-pressive exerciseExercise is performed 3 times per week for 6 weeks with moderate intensity for 20 min/session which includes diaphragmatic breathing, apnea, postural alignment (standing, seated, kneeling), and pelvic floor co-activation). | Other | Hypopressive Exercises |
| pelvic floor muscle trainingExercise is performed 3 times per week for 6 weeks with submaximal voluntary contraction (include both slow holds and quick flicks) for 20 min/session (each session includes multiple sets of 8 repetitions, hold for 5 seconds, with rest intervals). These Kegel exercises are performed in different positions. | Other | Pelvic Floor Muscle Training |
Primary outcome
Symptoms severity
Time frame: 6 weeks
Symptom severity due to SUI will assessed by International Consultation on Incontinence Questionnaire Urinary Incontinence short form (ICIQUI-SF) is a standardized, validated, self-administered questionnaire used to assess the severity of urinary incontinence (UI), influence quality of life, and situational triggers of leakage. It consists of four items: frequency of urine leakage, amount of urine leakage, overall impact of UI on daily life (rated on a 0-10 scale), and a self-diagnostic item asking when urine leaks (non-scored). The ICIQ-UI-SF showed a Cronbach's alpha value from 0.7 to 0.8, representing good internal consistency
1 secondary outcome
Incontinence Quality of life
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Yes. After the publication of the research
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypo-pressive exercise and pelvic floor muscle training in people with Stress Urinary Incontinence (SUI) and Stress Urinary Incontinence in Women, 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 27 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Symptoms severity (time frame: 6 weeks). 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 27 Aug 2026.