NCT06786182

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2024

Completed
20 days until next milestone

Study Start

First participant enrolled

November 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

October 26, 2024

Last Update Submit

January 15, 2025

Conditions

Keywords

Pelvic Floor HealthMale Pelvic Floor EducationUltrasound ImagingPelvic Floor Muscle TrainingPhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 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 baseline (pre-intervention) and at the end of the 4-week intervention period (post-intervention).

Study Arms (2)

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.

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.

Interventions

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.

EDUCATION

Eligibility Criteria

Age18 Years - 30 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men aged 18-30 years
  • Healthy men
  • Informed consent submitted, accepted and signed

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angel Gonzalez de la Flor

Madrid, Madrid, 28029, Spain

Location

Related Publications (4)

  • 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.

    PMID: 11135380BACKGROUND
  • Notenboom-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.

    PMID: 35876473BACKGROUND
  • Tuckett 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.

    PMID: 21599840BACKGROUND
  • Richter 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.

    PMID: 25891335BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinding will apply to the study evaluators. The evaluators will have no knowledge about the assignment of the participants, which ensures that the evaluation of the results is unbiased and not influenced by the group to which they belong.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 26, 2024

First Posted

January 22, 2025

Study Start

November 15, 2024

Primary Completion

December 30, 2024

Study Completion

January 15, 2025

Last Updated

January 22, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

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.

Locations