Pelvic Floor DisordersNCT06352112
Effects of the Hypopressive Exercises in Women With Pelvic Organ Prolapse
A study testing Pelvic Floor Muscle Training and Hypopressive Exercises in people with Pelvic Floor Disorders and Prolapse; Female, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was compare home-based pelvic floor muscle training (PFMT) alone and home-based PFMT combined with hypopressive exercise (HE) in terms of pelvic floor muscle (PFM) activation and severity of pelvic floor dysfunction (PFD) in women with pelvic organ prolapse (POP) for eight weeks. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Pelvic Floor Disorders, Prolapse; Female
- What is being tested?
- Pelvic Floor Muscle Training and Hypopressive Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2023to 15 Feb 2024
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- having been diagnosed with POP according to Pelvic Organ Prolapse Quantification System by a gynecologist;
- being literate
- being between 20-50 years
Who cannot join
- pregnancy;
- having a cooperation problems;
- history of active cancer;
- finding an urinary infection during evaluation;
- being in the menstrual period during the evaluation;
- neurological, orthopedic or serious medical conditions that may affect the patient's pelvic floor functions.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Research and Training Hospital
Istanbul
About this study
Official title: Short-term Effects of the Home-Based Hypopressive Exercises in Women With Pelvic Organ Prolapse: A Retrospective Comparative Study
The aim of this study was compare home-based pelvic floor muscle training (PFMT) alone and home-based PFMT combined with hypopressive exercise (HE) in terms of pelvic floor muscle (PFM) activation and severity of pelvic floor dysfunction (PFD) in women with pelvic organ prolapse (POP) for eight weeks. For this purpose, the participants were randomly divided into two groups: [PFMT alone (n:15) and PFMT combined with HE(n:17)]. DuoBravo EMG device for evaluation of PFM activation and "Pelvic Floor Distress Inventory-20" was used to evaluate the severity of PFD. All evaluations were performed twice in total, at baseline and at week 8.
Read the detailed description
Pelvic floor muscle training (PFMT), which provides increased structural support of the pelvic organs by improving the functional strength, endurance and coordination of the pelvic floor muscles (PFM), has been a grade A recommendation based on Level 1 evidence to improve symptoms and stages of pelvic organ prolapse (POP). On the other hand, hypopressive exercises (HE) are a group of exercises that, when applied, relax the diaphragm, activate the abdominal muscles, activate the transversus abdominis muscle by reducing intra-abdominal pressure, thus providing reflex activation in the PFM, and are known to improve urinary incontinence and POP with these features. Although there are studies investigating the effects of both exercise groups on POP, the results of the studies are contradictory and more research is needed on this subject.For this reason, in this study, the investigators aimed to compare home-based PFMT alone and home-based PFMT combined with HE in terms of PFM activation and severity of pelvic floor dysfunction in women with POP for eight weeks.
- Conditions
- Pelvic Floor Disorders, Prolapse; Female
- Being tested
- Pelvic Floor Muscle Training, Hypopressive Exercises
- Medical subject headings
- Pelvic Floor Disorders, Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle TrainingOther
PFMT consisted of both slow voluntary contractions lasting 15 seconds each (5-s contraction, 5-s hold and 5-s relaxation) and fast voluntary contractions lasting 2-s each. A set of exercises included 10 slow and 10 fast voluntary contractions. During the first week, women performed five sets of exercises a day, and the exercises were continued for eight weeks by increasing five sets each week. The exercises were performed as home exercises.
Hypopressive ExercisesOther
HE program in which different placements of the upper and lower extremities were used in standing, sitting and supine positions, and the participants were asked to perform the exercises with a "hypopressive maneuver" to maintain apnea and rib cage expansion for approximately 10 seconds. Exercises were started with three repetitions a day, and then the number of repetitions was increased to five and/or 10, depending on the participant's tolerance. The exercises were performed as home exercises.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Muscle Training | Experimental | Participants received pelvic floor muscle training only. Receives: Other: Pelvic Floor Muscle Training |
| Pelvic Floor Muscle Training combined with Hypopressive Exercises | Experimental | Participants received hypopressive exercise in addition to pelvic floor muscle training. Receives: Other: Pelvic Floor Muscle Training; Other: Hypopressive Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Floor Muscle Activation
It was performed with the DuoBravo EMG device. Patients were asked to squeeze the PFM strongly for 5-s and at the end of the contraction, to relax completely by not pushing the perineum downwards for 5-s. This cycle was repeated five times in total, and the muscle activation responses at the end of the measurement were recorded in µV.
Measured: at baseline and at week 8
Secondary outcomes (1)
Severity of pelvic floor dysfunction
It was performed with the "Pelvic Floor Distress inventory-20 (PFDI-20). The total score of the scale is between 0-300 and the higher the score obtained as a result of the survey, the greater the severity of pelvic floor dysfunction
Measured: at baseline and at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start15 Mar 2023
- Primary completion15 Jan 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Training and Research Hospital
- Responsible party
- Principal investigator, Turkan Akbayrak, Hacettepe University
- Investigators
- Türkan Akbayrak, Prof. Dr., Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352112
- Sponsor's protocol ID
- 02.04.2024 - POP
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Resende AP, Stupp L, Bernardes BT, Oliveira E, Castro RA, Girao MJ, Sartori MG. Can hypopressive exercises provide additional benefits to pelvic floor muscle training in women with pelvic organ prolapse? Neurourol Urodyn. 2012 Jan;31(1):121-5. doi: 10.1002/nau.21149. Epub 2011 Oct 28.
PubMed 22038880Bernardes BT, Resende AP, Stupp L, Oliveira E, Castro RA, Bella ZI, Girao MJ, Sartori MG. Efficacy of pelvic floor muscle training and hypopressive exercises for treating pelvic organ prolapse in women: randomized controlled trial. Sao Paulo Med J. 2012;130(1):5-9. doi: 10.1590/s1516-31802012000100002.
PubMed 22344353Resende 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 30311680Bo K, Angles-Acedo S, Batra A, Braekken IH, Chan YL, Jorge CH, Kruger J, Yadav M, Dumoulin C. Are hypopressive and other exercise programs effective for the treatment of pelvic organ prolapse? Int Urogynecol J. 2023 Jan;34(1):43-52. doi: 10.1007/s00192-022-05407-y. Epub 2022 Nov 23.
PubMed 36418569Molina-Torres G, Moreno-Munoz M, Rebullido TR, Castellote-Caballero Y, Bergamin M, Gobbo S, Hita-Contreras F, Cruz-Diaz D. The effects of an 8-week hypopressive exercise training program on urinary incontinence and pelvic floor muscle activation: A randomized controlled trial. Neurourol Urodyn. 2023 Feb;42(2):500-509. doi: 10.1002/nau.25110. Epub 2022 Dec 8.
PubMed 36482844
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of the Home-Based Hypopressive Exercises in Women With Pelvic Organ Prolapse: A Retrospective Comparative Study
- ClinicalTrials.gov ID
- NCT06352112
- Acronym / sponsor ID
- 02.04.2024 - POP
- Conditions
- Pelvic Floor Disorders, Prolapse; Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Istanbul Training and Research Hospital
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 8 Apr 2024 (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 aim of this study was compare home-based pelvic floor muscle training (PFMT) alone and home-based PFMT combined with hypopressive exercise (HE) in terms of pelvic floor muscle (PFM) activation and severity of pelvic floor dysfunction (PFD) in women with pelvic organ prolapse (POP) for eight weeks. For this purpose, the participants were randomly divided into two groups: [PFMT alone (n:15) and PFMT combined with HE(n:17)]. DuoBravo EMG device for evaluation of PFM activation and "Pelvic Floor Distress Inventory-20" was used to evaluate the severity of PFD. All evaluations were performed twice in total, at baseline and at week 8.
Detailed description
Pelvic floor muscle training (PFMT), which provides increased structural support of the pelvic organs by improving the functional strength, endurance and coordination of the pelvic floor muscles (PFM), has been a grade A recommendation based on Level 1 evidence to improve symptoms and stages of pelvic organ prolapse (POP). On the other hand, hypopressive exercises (HE) are a group of exercises that, when applied, relax the diaphragm, activate the abdominal muscles, activate the transversus abdominis muscle by reducing intra-abdominal pressure, thus providing reflex activation in the PFM, and are known to improve urinary incontinence and POP with these features. Although there are studies investigating the effects of both exercise groups on POP, the results of the studies are contradictory and more research is needed on this subject.For this reason, in this study, the investigators aimed to compare home-based PFMT alone and home-based PFMT combined with HE in terms of PFM activation and severity of pelvic floor dysfunction in women with POP for eight weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Muscle Training | Experimental | Other: Pelvic Floor Muscle TrainingParticipants received pelvic floor muscle training only. |
| Pelvic Floor Muscle Training combined with Hypopressive Exercises | Experimental | Other: Pelvic Floor Muscle Training, Other: Hypopressive ExercisesParticipants received hypopressive exercise in addition to pelvic floor muscle training. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- having been diagnosed with POP according to Pelvic Organ Prolapse Quantification System by a gynecologist;
- being literate
- being between 20-50 years
Key exclusion criteria (6 listed)
- pregnancy;
- having a cooperation problems;
- history of active cancer;
- finding an urinary infection during evaluation;
- being in the menstrual period during the evaluation;
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 |
|---|---|---|
| Pelvic Floor Muscle TrainingPFMT consisted of both slow voluntary contractions lasting 15 seconds each (5-s contraction, 5-s hold and 5-s relaxation) and fast voluntary contractions lasting 2-s each. A set of exercises included 10 slow and 10 fast voluntary contractions. During the first week, women performed five sets of exercises a day, and the exercises were continued for eight weeks by increasing five sets each week. The exercises were performed as home exercises. | Other | Pelvic Floor Muscle Training, Pelvic Floor Muscle Training combined with Hypopressive Exercises |
| Hypopressive ExercisesHE program in which different placements of the upper and lower extremities were used in standing, sitting and supine positions, and the participants were asked to perform the exercises with a "hypopressive maneuver" to maintain apnea and rib cage expansion for approximately 10 seconds. Exercises were started with three repetitions a day, and then the number of repetitions was increased to five and/or 10, depending on the participant's tolerance. The exercises were performed as home exercises. | Other | Pelvic Floor Muscle Training combined with Hypopressive Exercises |
Primary outcome
Pelvic Floor Muscle Activation
Time frame: at baseline and at week 8
It was performed with the DuoBravo EMG device. Patients were asked to squeeze the PFM strongly for 5-s and at the end of the contraction, to relax completely by not pushing the perineum downwards for 5-s. This cycle was repeated five times in total, and the muscle activation responses at the end of the measurement were recorded in µV.
1 secondary outcome
Severity of pelvic floor dysfunction
Time frame: at baseline and at week 8
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 10 Apr 2024.
- Results publication: PubMed 22038880Resende AP, Stupp L, Bernardes BT, Oliveira E, Castro RA, Girao MJ, Sartori MG. Can hypopressive exercises provide additional benefits to pelvic floor muscle training in women with pelvic organ prolapse? Neurourol Urodyn. 2012 Jan;31(1):121-5. doi: 10.1002/nau.21149. Epub 2011 Oct 28.
- Results publication: PubMed 22344353Bernardes BT, Resende AP, Stupp L, Oliveira E, Castro RA, Bella ZI, Girao MJ, Sartori MG. Efficacy of pelvic floor muscle training and hypopressive exercises for treating pelvic organ prolapse in women: randomized controlled trial. Sao Paulo Med J. 2012;130(1):5-9. doi: 10.1590/s1516-31802012000100002.
- Results publication: 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.
- Results publication: PubMed 36418569Bo K, Angles-Acedo S, Batra A, Braekken IH, Chan YL, Jorge CH, Kruger J, Yadav M, Dumoulin C. Are hypopressive and other exercise programs effective for the treatment of pelvic organ prolapse? Int Urogynecol J. 2023 Jan;34(1):43-52. doi: 10.1007/s00192-022-05407-y. Epub 2022 Nov 23.
- Results publication: PubMed 36482844Molina-Torres G, Moreno-Munoz M, Rebullido TR, Castellote-Caballero Y, Bergamin M, Gobbo S, Hita-Contreras F, Cruz-Diaz D. The effects of an 8-week hypopressive exercise training program on urinary incontinence and pelvic floor muscle activation: A randomized controlled trial. Neurourol Urodyn. 2023 Feb;42(2):500-509. doi: 10.1002/nau.25110. Epub 2022 Dec 8.
- 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.
Türkan Akbayrak, Prof. Dr. principal investigator
Hacettepe 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 Pelvic Floor Muscle Training and Hypopressive Exercises in people with Pelvic Floor Disorders and Prolapse; Female, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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 10 Apr 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 Turkey (Türkiye). 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 Floor Muscle Activation (time frame: at baseline and at week 8). 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 NCT06352112, which also lists 5 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 10 Apr 2024.