Pelvic Organ ProlapseNCT07440875
Effects of Pelvic Floor Muscle Training With & Without Hypopressive Exercises
A study testing hypopressive excercises and pelvic training excercises in people with Pelvic Organ Prolapse, run by Riphah International University at 1 site in Pakistan.
Trial summary
Pelvic Organ Prolapse (POP) is a prevalent condition affecting women's quality of life due to the descent of pelvic organs caused by weak pelvic floor muscles (PFMs). This randomized controlled trial aims to compare the effects of pelvic floor muscle training (PFMT) alone and PFMT combined with hypopressive exercises… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- hypopressive excercises and pelvic training excercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2025to Apr 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 45 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Married women
- Age 45-65 years
- Post menopausal
- uterine prolapse
- Stage I \& II
Who cannot join
- Pregnancy or Postpartum (within last 6 months)
- History of Pelvic floor surgery e.g.hysterectomy
- Pts with other comorbidities e.g. neuromuscluar disease
- Participating in other pelvic floor muscle program.e.g. pilates , yoga, Psychiatric disorders effecting compliance.e.g. schizopherenia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Qasim Sandhu Hospital
Lahore, Punjab Province, 6400
mehar un nisa UN NISA, MS, 03344563221, meharun.nisa@riphah.edu.pk
saweba irfan, MSPT-WH
About this study
Official title: Effects of Pelvic Floor Muscle Training With & Without Hypopressive Exercises On Strength, Dyspareunia and Quality Of Life in Pelvic Organ Prolapse
Pelvic Organ Prolapse (POP) is a prevalent condition affecting women's quality of life due to the descent of pelvic organs caused by weak pelvic floor muscles (PFMs). This randomized controlled trial aims to compare the effects of pelvic floor muscle training (PFMT) alone and PFMT combined with hypopressive exercises in improving pelvic floor muscle strength, reducing dyspareunia, and enhancing overall quality of life in women aged 45-65 diagnosed with stage I-II POP.This study will be randomized controlled trial and will be conducted in Qasim Sandhu Hospital, Muhammadi Medical Trust and Clinic 1. This will undergo 4 sessions totaling 1 month of treatment. . Non-probability convenience sampling technique will be used and 46 participants will be recruited in study after randomization.The subjects will be divided into two groups. Group A will receive pelvic floor muscle training with hypopressive exercises and Group B will receive pelvic floor muscle training without hypopressive exercises receiving baseline treatment.
Read the detailed description
he study will utilize tools such as the Oxford Grading Scale for muscle strength, the Numeric Pain Rating Scale (VAS) for pain, and the Pelvic Floor Impact Questionnaire (PFIQ-7) for quality of life assessment.Data will be analyzed by using Statistical Package for Social Science SPSS version 25 software to get results of treatment strategies. Statistical significance will be set at P = 0.05.Use of statistical tests will be decided after normality tests.In parametric, independence t-test and paired t-test will be used. In non-parametric, Man-Whitney test will be used.
The purpose of this study is to provide effective data on whether the combination of PFMT and hypopressive exercises offers improvements in pelvic floor strength, dyspareunia, and enhances the quality of life compared to PFMT alone.
Key Words Female,Pelvic Floor, Quality of Life, Dyspareunia, Exercise, Therapy Pelvic Organ Prolapse
- Conditions
- Pelvic Organ Prolapse
- Being tested
- hypopressive excercises, pelvic training excercises
- Keywords
- Female, Pelvic Floor, Quality of Life, Dyspareunia, Exercise, Pelvic Organ Prolapse
- Medical subject headings
- Pelvic Organ Prolapse, Dyspareunia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypopressive excercisesOther
The initial maneuver involved sustaining apnea with rib-cage expansion for approximately 10 seconds in supine, standing, and sitting positions.
Participants progressed through hypopressive postures including standing, kneeling, four-point kneeling, sitting, and supine, with varied limb positions.
Each hypopressive exercise consisted of 3 repetitions per posture, with a rest breath between repetitions.
Sessions included 5-10 hypopressive exercises based on participant skill and readiness, with each exercise repeated three times per session.
No voluntary contraction of pelvic floor or abdominal muscles was permitted during performance.
pelvic training excercisesOther
Week 1: Foundational breathing and supine hypopressive exercises performed 3×/week for 15-20 minutes to establish basic apnea control and postural awareness.
Week 2: Progression to seated and standing poses 4×/week for 20-25 minutes, increasing hold time and postural endurance.
Week 3: Advanced kneeling and squat-based hypopressive activation 4-5×/week for 25-30 minutes to integrate functional core control.
Week 4: Mastery phase with full squat, walking, and combination poses 5×/week for 30-35 minutes to enhance dynamic postural stability.
| Study group | Role | What they receive |
|---|---|---|
| hyopressive excercises | Experimental | The standardised intervention given to women in the PFMT group consisted of five appointments over a 4 weeks period . At the first appointment, a standardised history was taken, and both a subjective prolapse assessment and internal pelvic floor muscle assessment (using the Power Endurance Repetitions Fast Every Contraction Timed (PERFECT) scheme, including the modified Oxford scale were carried out.Women were also taught how to correctly contract the pelvic floor muscles and how to pre-contract the pelvic floor muscles individualized home exercise programme was prescribed, and women were encouraged to perform six sets of exercises daily with the use of an exercise diary to record compliance. A standardized lifestyle advice sheet was given to women containing all essential instructions Receives: Other: hypopressive excercises; Other: pelvic training excercises |
| pelvic training excercise | Active comparator | Week 1: Foundational breathing and supine hypopressive exercises performed 3×/week for 15-20 minutes to establish basic apnea control and postural awareness.
Week 2: Progression to seated and standing poses 4×/week for 20-25 minutes, increasing hold time and postural endurance.
Week 3: Advanced kneeling and squat-based hypopressive activation 4-5×/week for 25-30 minutes to integrate functional core control.
Week 4: Mastery phase with full squat, walking, and combination poses 5×/week for 30-35 minutes to enhance dynamic postural stability. Receives: Other: pelvic training excercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS) for assessment of pain
the test-retest reliability for the NPRS has been demonstrated to be moderate to high, varying from 0.67 to 0.96. Criterion validity has not been established for the NPRS as there are no 'gold standards' for pain measurement; however, when correlated with the VAS, the NPRS is determined to have 0.79 to 0.95 convergent validity.
Measured: 4 week
Modified Oxford Scale for assessment of muscle strength
The modified Oxford scale is a practical tool for use in clinical studies and can provide an adequate measure of PFM strength, provided a study is sufficiently powered. The Icc value r=0.97 and Cronbach @ is 0.845. The scale demonstrates high intra-rater reliability, meaning that the same clinician tends to produce consistent results when re-assessing the same patient
Measured: 4 weeks
PFIQ7 for assessment of quality of life
Pelvic Floor Impact Questionnaire-7 is valid, reliable, and responsive short forms of condition-specific quality-of-life questionnaires for women with pelvic floor disorders.Construct validity of the tool demonstrated by many fold higher scores among patients with POP compared with women without POP (p<0.0001)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Aug 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MEHAR UN NISA, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440875
- Sponsor's protocol ID
- REC/RCR&AHS/24/0541
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feigenbaum T. Physical Therapy in the Treatment and Prevention of Pelvic Floor Dysfunctions in Women. The Science Journal of the Lander College of Arts and Sciences. 2022;16(1)
Boraschi Gomes V, Fernandes Torres T, Merino D, Castiglione M, Pavione Rodrigues Pereira R, Tanaka C. (PM-05) EFFICACY OF PELVIC FLOOR MUSCLE TRAINING AND PERINEAL MASSAGE IN THE TREATMENT OF WOMEN WITH DYSPAREUNIA: NARRATIVE REVIEW OF THE LITERATURE. The Journal of Sexual Medicine. 2024;21
Wang T, Wen Z, Li M. The effect of pelvic floor muscle training for women with pelvic organ prolapse: a meta-analysis. Int Urogynecol J. 2022 Jul;33(7):1789-1801. doi: 10.1007/s00192-022-05139-z. Epub 2022 Mar 21.
PubMed 35312800Guan Y, Han J. Quality-of-life improvements in patients after various surgical treatments for pelvic organ prolapse. Arch Gynecol Obstet. 2024 Mar;309(3):813-820. doi: 10.1007/s00404-023-07140-3. Epub 2023 Jul 19.
PubMed 37464172
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pelvic Floor Muscle Training With & Without Hypopressive Exercises On Strength, Dyspareunia and Quality Of Life in Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT07440875
- Acronym / sponsor ID
- REC/RCR&AHS/24/0541
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Female, Pelvic Floor, Quality of Life, Dyspareunia, Exercise, Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 27 Feb 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.
Pelvic Organ Prolapse (POP) is a prevalent condition affecting women's quality of life due to the descent of pelvic organs caused by weak pelvic floor muscles (PFMs). This randomized controlled trial aims to compare the effects of pelvic floor muscle training (PFMT) alone and PFMT combined with hypopressive exercises in improving pelvic floor muscle strength, reducing dyspareunia, and enhancing overall quality of life in women aged 45-65 diagnosed with stage I-II POP.This study will be randomized controlled trial and will be conducted in Qasim Sandhu Hospital, Muhammadi Medical Trust and Clinic 1. This will undergo 4 sessions totaling 1 month of treatment. . Non-probability convenience sampling technique will be used and 46 participants will be recruited in study after randomization.The subjects will be divided into two groups. Group A will receive pelvic floor muscle training with hypopressive exercises and Group B will receive pelvic floor muscle training without hypopressive exercises receiving baseline treatment.
Detailed description
he study will utilize tools such as the Oxford Grading Scale for muscle strength, the Numeric Pain Rating Scale (VAS) for pain, and the Pelvic Floor Impact Questionnaire (PFIQ-7) for quality of life assessment.Data will be analyzed by using Statistical Package for Social Science SPSS version 25 software to get results of treatment strategies. Statistical significance will be set at P = 0.05.Use of statistical tests will be decided after normality tests.In parametric, independence t-test and paired t-test will be used. In non-parametric, Man-Whitney test will be used.
The purpose of this study is to provide effective data on whether the combination of PFMT and hypopressive exercises offers improvements in pelvic floor strength, dyspareunia, and enhances the quality of life compared to PFMT alone.
Key Words Female,Pelvic Floor, Quality of Life, Dyspareunia, Exercise, Therapy Pelvic Organ Prolapse
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyopressive excercises | Experimental | Other: hypopressive excercises, Other: pelvic training excercisesThe standardised intervention given to women in the PFMT group consisted of five appointments over a 4 weeks period . At the first appointment, a standardised history was taken, and both a subjective prolapse assessment and internal pelvic floor muscle assessment (using the Power Endurance Repetitions Fast Every Contraction Timed (PERFECT) scheme, including the modified Oxford scale were carried out.Women were also taught how to correctly contract the pelvic floor muscles and how to pre-contract the pelvic floor muscles individualized home exercise programme was prescribed, and women were encouraged to perform six sets of exercises daily with the use of an exercise diary to record compliance. A standardized lifestyle advice sheet was given to women containing all essential instructions |
| pelvic training excercise | Active comparator | Other: pelvic training excercisesWeek 1: Foundational breathing and supine hypopressive exercises performed 3×/week for 15-20 minutes to establish basic apnea control and postural awareness. Week 2: Progression to seated and standing poses 4×/week for 20-25 minutes, increasing hold time and postural endurance. Week 3: Advanced kneeling and squat-based hypopressive activation 4-5×/week for 25-30 minutes to integrate functional core control. Week 4: Mastery phase with full squat, walking, and combination poses 5×/week for 30-35 minutes to enhance dynamic postural stability. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Married women
- Age 45-65 years
- Post menopausal
- uterine prolapse
- Stage I \& II
Key exclusion criteria (4 listed)
- Pregnancy or Postpartum (within last 6 months)
- History of Pelvic floor surgery e.g.hysterectomy
- Pts with other comorbidities e.g. neuromuscluar disease
- Participating in other pelvic floor muscle program.e.g. pilates , yoga, Psychiatric disorders effecting compliance.e.g. schizopherenia
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 |
|---|---|---|
| hypopressive excercisesThe initial maneuver involved sustaining apnea with rib-cage expansion for approximately 10 seconds in supine, standing, and sitting positions. Participants progressed through hypopressive postures including standing, kneeling, four-point kneeling, sitting, and supine, with varied limb positions. Each hypopressive exercise consisted of 3 repetitions per posture, with a rest breath between repetitions. Sessions included 5-10 hypopressive exercises based on participant skill and readiness, with each exercise repeated three times per session. No voluntary contraction of pelvic floor or abdominal muscles was permitted during performance. | Other | hyopressive excercises |
| pelvic training excercisesWeek 1: Foundational breathing and supine hypopressive exercises performed 3×/week for 15-20 minutes to establish basic apnea control and postural awareness. Week 2: Progression to seated and standing poses 4×/week for 20-25 minutes, increasing hold time and postural endurance. Week 3: Advanced kneeling and squat-based hypopressive activation 4-5×/week for 25-30 minutes to integrate functional core control. Week 4: Mastery phase with full squat, walking, and combination poses 5×/week for 30-35 minutes to enhance dynamic postural stability. | Other | hyopressive excercises, pelvic training excercise |
Primary outcome
Numeric Pain Rating Scale (NPRS) for assessment of pain
Time frame: 4 week
the test-retest reliability for the NPRS has been demonstrated to be moderate to high, varying from 0.67 to 0.96. Criterion validity has not been established for the NPRS as there are no 'gold standards' for pain measurement; however, when correlated with the VAS, the NPRS is determined to have 0.79 to 0.95 convergent validity.
Modified Oxford Scale for assessment of muscle strength
Time frame: 4 weeks
The modified Oxford scale is a practical tool for use in clinical studies and can provide an adequate measure of PFM strength, provided a study is sufficiently powered. The Icc value r=0.97 and Cronbach @ is 0.845. The scale demonstrates high intra-rater reliability, meaning that the same clinician tends to produce consistent results when re-assessing the same patient
PFIQ7 for assessment of quality of life
Time frame: 4 weeks
Pelvic Floor Impact Questionnaire-7 is valid, reliable, and responsive short forms of condition-specific quality-of-life questionnaires for women with pelvic floor disorders.Construct validity of the tool demonstrated by many fold higher scores among patients with POP compared with women without POP (p<0.0001)
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 27 Feb 2026.
- BackgroundFeigenbaum T. Physical Therapy in the Treatment and Prevention of Pelvic Floor Dysfunctions in Women. The Science Journal of the Lander College of Arts and Sciences. 2022;16(1)
- BackgroundBoraschi Gomes V, Fernandes Torres T, Merino D, Castiglione M, Pavione Rodrigues Pereira R, Tanaka C. (PM-05) EFFICACY OF PELVIC FLOOR MUSCLE TRAINING AND PERINEAL MASSAGE IN THE TREATMENT OF WOMEN WITH DYSPAREUNIA: NARRATIVE REVIEW OF THE LITERATURE. The Journal of Sexual Medicine. 2024;21
- Background: PubMed 35312800Wang T, Wen Z, Li M. The effect of pelvic floor muscle training for women with pelvic organ prolapse: a meta-analysis. Int Urogynecol J. 2022 Jul;33(7):1789-1801. doi: 10.1007/s00192-022-05139-z. Epub 2022 Mar 21.
- Background: PubMed 37464172Guan Y, Han J. Quality-of-life improvements in patients after various surgical treatments for pelvic organ prolapse. Arch Gynecol Obstet. 2024 Mar;309(3):813-820. doi: 10.1007/s00404-023-07140-3. Epub 2023 Jul 19.
- Individual participant dataSharing planned: No
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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.
MEHAR UN NISA, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypopressive excercises and pelvic training excercises in people with Pelvic Organ Prolapse, run by Riphah International University 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 4 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: looking for participants now, as of the sponsor's last update on 27 Feb 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?
Contact imran amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) for assessment of pain (time frame: 4 week). 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?
On the ClinicalTrials.gov record for NCT07440875, which also lists 4 linked publications.
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 Feb 2026.