Pelvic FloorNCT06786182
Effectiveness of Abdomino-pelvic Muscle Contraction Education Programme in Healthy Male University Students
A study testing PFM Educational Program in people with Pelvic Floor and Abdominal Muscles, run by European University of Madrid at 1 site in Spain.
Trial summary
This research study investigates the effectiveness of an educational intervention aimed at improving awareness and control of pelvic floor (PF) and abdominal muscle contractions in healthy young male university students. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor, Abdominal Muscles, Abdominal Muscles/ultrasonography
- What is being tested?
- PFM Educational Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSpain
- Study dates
- 15 Nov 2024to 15 Jan 2025
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men aged 18-30 years
- Healthy men
- Informed consent submitted, accepted and signed
Who cannot join
- Patients undergoing abdominal cavity surgery
- Patients with cognitive/proprioceptive impairments
- Patients who have had physiotherapy interventions of PFM
- Patients with low scores on the Spanish-validated SHIM sexual health questionnaire for males.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Pelvic Floor Contraction and Abdomino-pelvic Muscle Contraction Education Programme in Healthy Male University Students: a Pilot Study
This research study investigates the effectiveness of an educational intervention aimed at improving awareness and control of pelvic floor (PF) and abdominal muscle contractions in healthy young male university students. Using ultrasound imaging, the study measures abdominal wall muscle thickness at rest and during pelvic floor contraction, Active Straight Leg Raise (ASLR) test, and hollowing maneuvers in a randomized control trial.
Read the detailed description
The study addresses the largely overlooked area of male PF health, aiming to increase awareness and improve muscle control in healthy young men. A two-group design will be used to compare abdominal and PF muscle activation between a control group and an intervention group that receives online educational content. The intervention group will participate in a telematic program covering topics such as PF anatomy, muscle function, and the importance of proper muscle activation.
The study will use diagnostic ultrasound to measure thickness changes in the transverse abdominis (TrA), internal oblique (IO), and external oblique (EO) muscles before and after the intervention in both groups under different conditions: PF rest, PF contraction, single-leg raise (ASLR) test, and the hollowing maneuver.
- Being tested
- PFM Educational Program
- Keywords
- Pelvic Floor Health, Male Pelvic Floor Education, Ultrasound Imaging, Pelvic Floor Muscle Training, Physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFM Educational ProgramBehavioural
A structured telematic educational program covering PFM anatomy, function, and proper activation techniques. Content includes videos, visual guides, and exercises aimed at promoting PFM co-contraction and awareness.
| Study group | Role | What they receive |
|---|---|---|
| EDUCATION | Experimental | Participants receive an educational program focused on improving awareness and activation of the pelvic floor muscles and abdominal muscle synergy through telematic resources. Receives: Behavioral: PFM Educational Program |
| Control | No intervention | Participants in this group receive no educational intervention and participate only in baseline and follow-up assessments of abdominal and PFM activation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of the Transverse Abdominal Muscle (TrA)
Assessed at rest, during Pelvic floor (PF) contraction and during Active Straight Leg Raise (ASRL) via ultrasound,in centimetres
Measured: Measured at baseline (pre-intervention) and at the end of the 4-week intervention period (post-intervention).
Secondary outcomes (1)
Thickness of the External (OE) and Internal Oblique (OI) Muscles
Measured at rest, during PF contraction, and with the ASLR test using ultrasound, in centimeters
Measured: Measured at baseline (pre-intervention) and at the end of the 4-week intervention period (post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start15 Nov 2024
- Primary completion30 Dec 2024
- Study completion15 Jan 2025
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 FloorStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a randomized controlled trial (RCT) design with a parallel-group model. Participants are allocated to either a control group or an intervention group using a 1:1 ratio. The intervention group receives a structured educational program delivered via telematic resources, covering topics such as pelvic floor muscle (PFM) anatomy, function, and proper muscle activation techniques. The control group does not receive this educational intervention. Both groups undergo baseline and post-intervention ultrasound assessments to measure abdominal and PFM activation during various maneuvers, including resting, PFM contraction, the Active Straight Leg Raise (ASLR) test, and the hollowing maneuver. This model aims to evaluate the impact of the educational intervention on muscle co-contraction and activation patterns.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University of Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta de la Plaza, European University of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786182
- Sponsor's protocol ID
- 2024-442
- Status last verified
- Jan 2025
- First submitted
- 26 Oct 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, we do not plan to share Individual Participant Data (IPD) with other researchers. We will publish aggregated results from the study, ensuring that all data is de-identified to protect participant confidentiality.
Publications
Sapsford RR, Hodges PW, Richardson CA, Cooper DH, Markwell SJ, Jull GA. Co-activation of the abdominal and pelvic floor muscles during voluntary exercises. Neurourol Urodyn. 2001;20(1):31-42. doi: 10.1002/1520-6777(2001)20:13.0.co;2-p.
PubMed 11135380Notenboom-Nas FJM, Knol-de Vries GE, Beijer L, Tolsma Y, Slieker-Ten Hove MCP, Dekker JH, van Koeveringe GA, Blanker MH. Exploring pelvic floor muscle function in men with and without pelvic floor symptoms: A population-based study. Neurourol Urodyn. 2022 Nov;41(8):1739-1748. doi: 10.1002/nau.24996. Epub 2022 Jul 25.
PubMed 35876473Tuckett AG, Hodgkinson B, Hegney DG, Paterson J, Kralik D. Effectiveness of educational interventions to raise men's awareness of bladder and bowel health. Int J Evid Based Healthc. 2011 Jun;9(2):81-96. doi: 10.1111/j.1744-1609.2011.00208.x.
PubMed 21599840Richter LA, Gutman RE, Tefera E, Estep A, Iglesia CB. Knowledge of erectile dysfunction and pelvic floor disorders among young adults: a cross-sectional study. Can J Urol. 2015 Apr;22(2):7715-9.
PubMed 25891335
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Pelvic Floor Contraction and Abdomino-pelvic Muscle Contraction Education Programme in Healthy Male University Students: a Pilot Study
- ClinicalTrials.gov ID
- NCT06786182
- Acronym / sponsor ID
- 2024-442
- Keywords
- Pelvic Floor Health, Male Pelvic Floor Education, Ultrasound Imaging, Pelvic Floor Muscle Training, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- European University of MadridUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 22 Jan 2025 (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.
This research study investigates the effectiveness of an educational intervention aimed at improving awareness and control of pelvic floor (PF) and abdominal muscle contractions in healthy young male university students. Using ultrasound imaging, the study measures abdominal wall muscle thickness at rest and during pelvic floor contraction, Active Straight Leg Raise (ASLR) test, and hollowing maneuvers in a randomized control trial.
Detailed description
The study addresses the largely overlooked area of male PF health, aiming to increase awareness and improve muscle control in healthy young men. A two-group design will be used to compare abdominal and PF muscle activation between a control group and an intervention group that receives online educational content. The intervention group will participate in a telematic program covering topics such as PF anatomy, muscle function, and the importance of proper muscle activation.
The study will use diagnostic ultrasound to measure thickness changes in the transverse abdominis (TrA), internal oblique (IO), and external oblique (EO) muscles before and after the intervention in both groups under different conditions: PF rest, PF contraction, single-leg raise (ASLR) test, and the hollowing maneuver.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study uses a randomized controlled trial (RCT) design with a parallel-group model. Participants are allocated to either a control group or an intervention group using a 1:1 ratio. The intervention group receives a structured educational program delivered via telematic resources, covering topics such as pelvic floor muscle (PFM) anatomy, function, and proper muscle activation techniques. The control group does not receive this educational intervention. Both groups undergo baseline and post-intervention ultrasound assessments to measure abdominal and PFM activation during various maneuvers, including resting, PFM contraction, the Active Straight Leg Raise (ASLR) test, and the hollowing maneuver. This model aims to evaluate the impact of the educational intervention on muscle co-contraction and activation patterns.
| Arm | Type | Receives |
|---|---|---|
| EDUCATION | Experimental | Behavioral: PFM Educational ProgramParticipants receive an educational program focused on improving awareness and activation of the pelvic floor muscles and abdominal muscle synergy through telematic resources. |
| Control | No intervention | –Participants in this group receive no educational intervention and participate only in baseline and follow-up assessments of abdominal and PFM activation. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men aged 18-30 years
- Healthy men
- Informed consent submitted, accepted and signed
Key exclusion criteria (4 listed)
- Patients undergoing abdominal cavity surgery
- Patients with cognitive/proprioceptive impairments
- Patients who have had physiotherapy interventions of PFM
- Patients with low scores on the Spanish-validated SHIM sexual health questionnaire for males.
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 |
|---|---|---|
| PFM Educational ProgramA structured telematic educational program covering PFM anatomy, function, and proper activation techniques. Content includes videos, visual guides, and exercises aimed at promoting PFM co-contraction and awareness. | Behavioural | EDUCATION |
Primary outcome
Thickness of the Transverse Abdominal Muscle (TrA)
Time frame: Measured at baseline (pre-intervention) and at the end of the 4-week intervention period (post-intervention).
Assessed at rest, during Pelvic floor (PF) contraction and during Active Straight Leg Raise (ASRL) via ultrasound,in centimetres
1 secondary outcome
Thickness of the External (OE) and Internal Oblique (OI) Muscles
Time frame: Measured at baseline (pre-intervention) and at the end of the 4-week intervention period (post-intervention).
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 22 Jan 2025.
- Background: PubMed 11135380Sapsford RR, Hodges PW, Richardson CA, Cooper DH, Markwell SJ, Jull GA. Co-activation of the abdominal and pelvic floor muscles during voluntary exercises. Neurourol Urodyn. 2001;20(1):31-42. doi: 10.1002/1520-6777(2001)20:13.0.co;2-p.
- Background: PubMed 35876473Notenboom-Nas FJM, Knol-de Vries GE, Beijer L, Tolsma Y, Slieker-Ten Hove MCP, Dekker JH, van Koeveringe GA, Blanker MH. Exploring pelvic floor muscle function in men with and without pelvic floor symptoms: A population-based study. Neurourol Urodyn. 2022 Nov;41(8):1739-1748. doi: 10.1002/nau.24996. Epub 2022 Jul 25.
- Background: PubMed 21599840Tuckett AG, Hodgkinson B, Hegney DG, Paterson J, Kralik D. Effectiveness of educational interventions to raise men's awareness of bladder and bowel health. Int J Evid Based Healthc. 2011 Jun;9(2):81-96. doi: 10.1111/j.1744-1609.2011.00208.x.
- Background: PubMed 25891335Richter LA, Gutman RE, Tefera E, Estep A, Iglesia CB. Knowledge of erectile dysfunction and pelvic floor disorders among young adults: a cross-sectional study. Can J Urol. 2015 Apr;22(2):7715-9.
- Individual participant dataSharing planned: No. No, we do not plan to share Individual Participant Data (IPD) with other researchers. We will publish aggregated results from the study, ensuring that all data is de-identified to protect participant confidentiality.
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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 PFM Educational Program in people with Pelvic Floor and Abdominal Muscles, run by European University of Madrid at 1 site in Spain.
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 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: finished, as of the sponsor's last update on 22 Jan 2025. 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 Spain. 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?
Thickness of the Transverse Abdominal Muscle (TrA) (time frame: Measured at baseline (pre-intervention) and at the end of the 4-week intervention period (post-intervention).). 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 NCT06786182, 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 22 Jan 2025.