Clinical trial NCT06786182: Effectiveness of Abdomino-pelvic Muscle Contraction Education Programme in Healthy Male University Students
Official title: Effectiveness of a Pelvic Floor Contraction and Abdomino-pelvic Muscle Contraction Education Programme in Healthy Male University Students: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Floor
Abdominal Muscles
Abdominal Muscles/ultrasonography
Keywords: Pelvic Floor Health
Male Pelvic Floor Education
Ultrasound Imaging
Pelvic Floor Muscle Training
Physiotherapy
Lead sponsor: European University of Madrid
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 29
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Thickness of the Transverse Abdominal Muscle (TrA)
timeFrame: Measured at baseline (pre-intervention) and at the end of the 4-week intervention period (post-intervention).
Secondary outcomes:
measure: Thickness of the External (OE) and Internal Oblique (OI) Muscles
timeFrame: Measured at baseline (pre-intervention) and at the end of the 4-week intervention period (post-intervention).
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Angel Gonzalez de la Flor
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.