Pelvic Organ ProlapseNCT05719584
Pelvic Floor Muscle Training With and Without Hypopressive Exercises in Postmenopausal Females.
A study testing hypopressive exercises and pelvic floor muscle training in people with Pelvic Organ Prolapse, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effects of pelvic floor muscle training with and without hypopressive exercises on pelvic organ prolapse in postmenopausal females Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- hypopressive exercises and pelvic floor muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2022to 1 Aug 2023
- 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 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Multigravida
- Previous spontaneous vaginal deliveries
- Diagnosed Stage 1 and 2 pelvic organ prolapse
- Post-menopausal females
Who cannot join
- History of cesarean section
- History of ovarian cysts
- History of UTIs
- History of neoplasm
- Instrumental deliveries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pelvic Floor Muscle Training With and Without Hypopressive Exercises on Pelvic Organ Prolapse in Postmenopausal Females.
To compare the effects of pelvic floor muscle training with and without hypopressive exercises on pelvic organ prolapse in postmenopausal females
Read the detailed description
In this randomized controlled trial multigravida, postmenopausal females with stage 1 and 2 pelvic organ prolapse will be taken (exclusion criteria includes cesarean section females, ovarian cysts ,UTIs and neoplasm). This study will be conducted in Jinnah hospital , Lahore. Sample size of 36 will be taken according to inclusion criteria. Study will be completed in 10 months after approval of synopsis. Non-Probability convenient sampling will be used. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups through lottery method, to either the Pelvic floor muscle training group or group with combined pelvic floor muscle exercise and hypopressive exercise. Treatment period will be 12 weeks 3 days per week. The participants will be advised not to use other forms of treatment during the trial (pharmacologic or non pharmacologic treatment). All subjects will be assessed before and after treatment by POP-Q, pelvic floor impact questionnaire and P-QOL. Data will be analyzed by using SPSS 25 statistical software.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- hypopressive exercises, pelvic floor muscle training
- Keywords
- pelvic organ prolapse, postmenopausal, females, exercises
- Medical subject headings
- Pelvic Organ Prolapse, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypopressive exercisesOther
patients will receive pelvic floor muscle training with hypopressive exercises at outpatient department. Treatment will continue for 12 weeks 3 days per week. They will receive information about the localization and function of the PFM and transversus abdominis (TrA) muscles. Next, lying in a supine position with flexed knees and hips, they will localize their own pelvic floor with the help of touching their perineum. Then they will be instructed how to contract the PFM correctly, then they will directed to contract PFMs and in the end participants will be taught how to voluntarily contract the PFM simultaneously with diaphragmatic Aspiration(8-10 repetitions daily
pelvic floor muscle trainingOther
patients will receive only pelvic floor muscle training exercises(pelvic floor muscle contractions) at the outpatient department and treatment will continue for 12 weeks 3 days per week. PFMT will be performed in the lying, sitting and standing positions. The patients will be instructed to perform three sets of 8-12 maximum voluntary contractions held for 6 sec, with 12 sec of rest between each contraction, followed by three fast contractions in a row
| Study group | Role | What they receive |
|---|---|---|
| hypopressive exercises | Experimental | pelvic floor muscle exercises along with hypopressive exercises Receives: Other: hypopressive exercises; Other: pelvic floor muscle training |
| pelvic floor muscle training | Active comparator | pelvic floor muscle exercises alone Receives: Other: pelvic floor muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
pelvic organ prolapse quantification (POP-Q)
POP-Q can be seen in Many clinical settings \& published researches and it is used to grade and measure of pelvic organ prolapse during its assessment.
Measured: 12th week
Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
It is a short and less comprehensive version of Pelvic Floor Impact Questionnaire (PFIQ). It is a health related questionnaire for women with pelvic floor conditions.
consists of 7 questions that need to be answered 3 times each.
Measured: 12th week
Prolapse Quality of life questionnaire(P-QOL)
A simple, valid, reliable questionnaire to assess the severity of symptoms and their impact on the quality of life in women with Pelvic organ prolapse. There are several questions which a participant needs to answer.
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Sep 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hina gul, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719584
- Sponsor's protocol ID
- REC/RCR & AHS/23/0502
- Status last verified
- Dec 2024
- First submitted
- 31 Jan 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nam G, Lee SR, Choi S. Clitoromegaly, Vulvovaginal Hemangioma Mimicking Pelvic Organ Prolapse, and Heavy Menstrual Bleeding: Gynecologic Manifestations of Klippel-Trenaunay Syndrome. Medicina (Kaunas). 2021 Apr 9;57(4):366. doi: 10.3390/medicina57040366.
PubMed 33918633Alves FK, Riccetto C, Adami DB, Marques J, Pereira LC, Palma P, Botelho S. A pelvic floor muscle training program in postmenopausal women: A randomized controlled trial. Maturitas. 2015 Jun;81(2):300-5. doi: 10.1016/j.maturitas.2015.03.006. Epub 2015 Mar 14.
PubMed 25862491Barber MD. Pelvic organ prolapse. BMJ. 2016 Jul 20;354:i3853. doi: 10.1136/bmj.i3853. No abstract available.
PubMed 27439423Fatima Q, Razzaqe H, Kashif M, Aslam F. Association of parity and pelvic organ prolapse. Journal of Rawalpindi Medical College Students Supplement. 2016;20:104-8.
Resende APM, Bernardes BT, Stupp L, Oliveira E, Castro RA, Girao MJBC, Sartori MGF. Pelvic floor muscle training is better than hypopressive exercises in pelvic organ prolapse treatment: An assessor-blinded randomized controlled trial. Neurourol Urodyn. 2019 Jan;38(1):171-179. doi: 10.1002/nau.23819. Epub 2018 Oct 12.
PubMed 30311680Parle J, Shahmalak S, Irkar D. Effect of Hypopressive exercise in women with Pelvic Organ Prolapse. Nepal Journal of Obstetrics and Gynaecology. 2021;16(1).
Fleischer K, Thiagamoorthy G. Pelvic organ prolapse management. Post Reprod Health. 2020 Jun;26(2):79-85. doi: 10.1177/2053369120937594.
PubMed 32627701Navarro-Brazalez B, Prieto-Gomez V, Prieto-Merino D, Sanchez-Sanchez B, McLean L, Torres-Lacomba M. Effectiveness of Hypopressive Exercises in Women with Pelvic Floor Dysfunction: A Randomised Controlled Trial. J Clin Med. 2020 Apr 17;9(4):1149. doi: 10.3390/jcm9041149.
PubMed 32316686Navarro Brazalez B, Sanchez Sanchez B, Prieto Gomez V, De La Villa Polo P, McLean L, Torres Lacomba M. Pelvic floor and abdominal muscle responses during hypopressive exercises in women with pelvic floor dysfunction. Neurourol Urodyn. 2020 Feb;39(2):793-803. doi: 10.1002/nau.24284. Epub 2020 Jan 27.
PubMed 31985114Juez L, Nunez-Cordoba JM, Couso N, Auba M, Alcazar JL, Minguez JA. Hypopressive technique versus pelvic floor muscle training for postpartum pelvic floor rehabilitation: A prospective cohort study. Neurourol Urodyn. 2019 Sep;38(7):1924-1931. doi: 10.1002/nau.24094. Epub 2019 Jul 11.
PubMed 31297874
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pelvic Floor Muscle Training With and Without Hypopressive Exercises on Pelvic Organ Prolapse in Postmenopausal Females.
- ClinicalTrials.gov ID
- NCT05719584
- Acronym / sponsor ID
- REC/RCR & AHS/23/0502
- Conditions
- Pelvic Organ Prolapse
- Keywords
- pelvic organ prolapse, postmenopausal, females, exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 9 Feb 2023 (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.
To compare the effects of pelvic floor muscle training with and without hypopressive exercises on pelvic organ prolapse in postmenopausal females
Detailed description
In this randomized controlled trial multigravida, postmenopausal females with stage 1 and 2 pelvic organ prolapse will be taken (exclusion criteria includes cesarean section females, ovarian cysts ,UTIs and neoplasm). This study will be conducted in Jinnah hospital , Lahore. Sample size of 36 will be taken according to inclusion criteria. Study will be completed in 10 months after approval of synopsis. Non-Probability convenient sampling will be used. A written consent form will be taken from participants meeting inclusion criteria and will be randomly allocated into two groups through lottery method, to either the Pelvic floor muscle training group or group with combined pelvic floor muscle exercise and hypopressive exercise. Treatment period will be 12 weeks 3 days per week. The participants will be advised not to use other forms of treatment during the trial (pharmacologic or non pharmacologic treatment). All subjects will be assessed before and after treatment by POP-Q, pelvic floor impact questionnaire and P-QOL. Data will be analyzed by using SPSS 25 statistical software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypopressive exercises | Experimental | Other: hypopressive exercises, Other: pelvic floor muscle trainingpelvic floor muscle exercises along with hypopressive exercises |
| pelvic floor muscle training | Active comparator | Other: pelvic floor muscle trainingpelvic floor muscle exercises alone |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Multigravida
- Previous spontaneous vaginal deliveries
- Diagnosed Stage 1 and 2 pelvic organ prolapse
- Post-menopausal females
Key exclusion criteria (5 listed)
- History of cesarean section
- History of ovarian cysts
- History of UTIs
- History of neoplasm
- Instrumental deliveries
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 exercisespatients will receive pelvic floor muscle training with hypopressive exercises at outpatient department. Treatment will continue for 12 weeks 3 days per week. They will receive information about the localization and function of the PFM and transversus abdominis (TrA) muscles. Next, lying in a supine position with flexed knees and hips, they will localize their own pelvic floor with the help of touching their perineum. Then they will be instructed how to contract the PFM correctly, then they will directed to contract PFMs and in the end participants will be taught how to voluntarily contract the PFM simultaneously with diaphragmatic Aspiration(8-10 repetitions daily | Other | hypopressive exercises |
| pelvic floor muscle trainingpatients will receive only pelvic floor muscle training exercises(pelvic floor muscle contractions) at the outpatient department and treatment will continue for 12 weeks 3 days per week. PFMT will be performed in the lying, sitting and standing positions. The patients will be instructed to perform three sets of 8-12 maximum voluntary contractions held for 6 sec, with 12 sec of rest between each contraction, followed by three fast contractions in a row | Other | hypopressive exercises, pelvic floor muscle training |
Primary outcome
pelvic organ prolapse quantification (POP-Q)
Time frame: 12th week
POP-Q can be seen in Many clinical settings \& published researches and it is used to grade and measure of pelvic organ prolapse during its assessment.
Pelvic Floor Impact Questionnaire-7 (PFIQ-7)
Time frame: 12th week
It is a short and less comprehensive version of Pelvic Floor Impact Questionnaire (PFIQ). It is a health related questionnaire for women with pelvic floor conditions. consists of 7 questions that need to be answered 3 times each.
Prolapse Quality of life questionnaire(P-QOL)
Time frame: 12th week
A simple, valid, reliable questionnaire to assess the severity of symptoms and their impact on the quality of life in women with Pelvic organ prolapse. There are several questions which a participant needs to answer.
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 Dec 2024.
- Background: PubMed 33918633Nam G, Lee SR, Choi S. Clitoromegaly, Vulvovaginal Hemangioma Mimicking Pelvic Organ Prolapse, and Heavy Menstrual Bleeding: Gynecologic Manifestations of Klippel-Trenaunay Syndrome. Medicina (Kaunas). 2021 Apr 9;57(4):366. doi: 10.3390/medicina57040366.
- Background: PubMed 25862491Alves FK, Riccetto C, Adami DB, Marques J, Pereira LC, Palma P, Botelho S. A pelvic floor muscle training program in postmenopausal women: A randomized controlled trial. Maturitas. 2015 Jun;81(2):300-5. doi: 10.1016/j.maturitas.2015.03.006. Epub 2015 Mar 14.
- Background: PubMed 27439423Barber MD. Pelvic organ prolapse. BMJ. 2016 Jul 20;354:i3853. doi: 10.1136/bmj.i3853. No abstract available.
- BackgroundFatima Q, Razzaqe H, Kashif M, Aslam F. Association of parity and pelvic organ prolapse. Journal of Rawalpindi Medical College Students Supplement. 2016;20:104-8.
- Background: PubMed 30311680Resende APM, Bernardes BT, Stupp L, Oliveira E, Castro RA, Girao MJBC, Sartori MGF. Pelvic floor muscle training is better than hypopressive exercises in pelvic organ prolapse treatment: An assessor-blinded randomized controlled trial. Neurourol Urodyn. 2019 Jan;38(1):171-179. doi: 10.1002/nau.23819. Epub 2018 Oct 12.
- BackgroundParle J, Shahmalak S, Irkar D. Effect of Hypopressive exercise in women with Pelvic Organ Prolapse. Nepal Journal of Obstetrics and Gynaecology. 2021;16(1).
- Background: PubMed 32627701Fleischer K, Thiagamoorthy G. Pelvic organ prolapse management. Post Reprod Health. 2020 Jun;26(2):79-85. doi: 10.1177/2053369120937594.
- Background: PubMed 32316686Navarro-Brazalez B, Prieto-Gomez V, Prieto-Merino D, Sanchez-Sanchez B, McLean L, Torres-Lacomba M. Effectiveness of Hypopressive Exercises in Women with Pelvic Floor Dysfunction: A Randomised Controlled Trial. J Clin Med. 2020 Apr 17;9(4):1149. doi: 10.3390/jcm9041149.
- Background: PubMed 31985114Navarro Brazalez B, Sanchez Sanchez B, Prieto Gomez V, De La Villa Polo P, McLean L, Torres Lacomba M. Pelvic floor and abdominal muscle responses during hypopressive exercises in women with pelvic floor dysfunction. Neurourol Urodyn. 2020 Feb;39(2):793-803. doi: 10.1002/nau.24284. Epub 2020 Jan 27.
- Background: PubMed 31297874Juez L, Nunez-Cordoba JM, Couso N, Auba M, Alcazar JL, Minguez JA. Hypopressive technique versus pelvic floor muscle training for postpartum pelvic floor rehabilitation: A prospective cohort study. Neurourol Urodyn. 2019 Sep;38(7):1924-1931. doi: 10.1002/nau.24094. Epub 2019 Jul 11.
- A study conducted in 2023 by Guadalupe Molina-Torres et al, was to assess the effects of an 8-week, highly supervised programme of hypopressive exercises on the strength of the pelvic floor muscles and the signs and symptoms of urinary incontinence.Link provided by the sponsor.
- 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. This study is not recruiting at the moment.
hina gul, MS-OMPT 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 exercises and pelvic floor muscle training 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 4 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 Dec 2024. 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?
pelvic organ prolapse quantification (POP-Q) (time frame: 12th 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 NCT05719584, which also lists 10 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 Dec 2024.