Men&apos
Conditions
Interventions
This is a randomized, placebo-controlled (sham), triple-blind, parallel-group clinical trial with 55 volunteers. The study presents a 2×2 factorial design in the active groups, considering the combina
Sponsors
Universidade Federal do Delta do Parnaíba - UFDPar
Universidade Federal do Delta do Parnaíba - UFDPar
Eligibility
Sex/Gender
Male
Age
18 Years to 29 Years
Inclusion criteria
Inclusion criteria: Healthy cisgender men; 18 to 29 years old; sexually active; body mass index between 18.5 and 29.9 kg/m2; must sign the Informed Consent Form; be available; fully complete the assessment instruments; have testosterone levels equal to or greater than 300
Exclusion criteria
Exclusion criteria: History of cardiovascular, metabolic, neurological, or urological diseases; use of vasodilators, anticoagulants, antidepressants, or hormones; active inflammation of the genitourinary system; penile deformities, such as cavernous fibrosis and Peyronie's disease; sexually transmitted infections, such as human immunodeficiency virus (HIV), syphilis, hepatitis B and C; lesions, open wounds, and burns on the penis; premature ejaculation; dependence on nicotine, alcohol, and psychostimulant drugs; major depressive episode, psychotic syndrome, and generalized anxiety disorder; restriction or refusal to be exposed to audiovisual sexual stimulation; requesting to withdraw from the research at any time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Penile functional electrical stimulation is expected to increase blood flow in the corpora cavernosa, as evidenced by the peak systolic velocity obtained through penile doppler ultrasound;Different combinations of pulse frequency and duration are expected to produce distinct effects on hemodynamic parameters, allowing the identification of which parameters promote greater efficiency in penile perfusion. The sham control group will serve as a reference to evaluate the placebo effect, maintaining participant blinding and methodological consistency of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes are expected in end-diastolic velocity and resistance index, reflecting possible adjustments in the veno-occlusive mechanism and the efficiency of penile circulation;The intervention is expected to influence penile tumescence parameters, as well as penile anthropometric measurements | — |
Countries
BR
Contacts
Public ContactMatheaus da Costa
Universidade Federal do Delta do Parnaíba - UFDPar
Outcome results
None listed