Hypothesis / aims of study
Conservative treatment for Erectile Dysfunction (ED) may have adverse effects or be ineffective, demanding the investigation of new therapeutic approaches[1]. Thus, this study aimed to evaluate the hemodynamic response in men with ED undergoing radiofrequency therapy, low-intensity shock wave therapy, and combined therapy.
Study design, materials and methods
This randomized clinical trial included men aged 20 to 80 years with recurrent complaints of difficulty in obtaining or maintaining a sufficient erection for sexual satisfaction. Exclusion criteria included: prostatectomy surgery within the last six months, neurological diseases, uncontrolled diabetes mellitus or hypertension, Peyronie’s disease, psychiatric disorders, anatomical genital malformations, or penile prosthesis. Participants completed a sociodemographic and basic anamnesis questionnaire. Penile Doppler Ultrasound (Mindray, China) was performed after administering an inductive injection from Flukka® laboratory, followed by measurements of Peak Systolic Velocity (PSV) and End-Diastolic Velocity (EDV) in both corpora cavernosa.
Participants were randomized into three groups: non-ablative radiofrequency (gRF): Treatment using Neartek equipment (IBRAMED, Brazil), with bilateral application to the penis at a temperature of 39ºC to 41ºC for two minutes; Low-Intensity Shock Wave Therapy (gLI-SWT): Treatment using THORK ShockWave equipment (IBRAMED, Brazil), in a supine position, with a frequency of 12 Hz, energy of 180 mJ, and 2,000 pulses per side of the penis and; Combined Therapy Group (gCT): Patients initially received radiofrequency therapy, followed by shock wave therapy. Each group underwent 12 sessions, twice per week. Statistical analysis included Chi-Square tests for paired categorical variables, ANOVA, and Bonferroni correction for comparisons among intervention groups. Sample size calculation assumed an alpha of 5%, a power of 80%, a standard deviation (SD) of 3.23 based on Kalyvianakis[2], and an expected difference of 3 cm/s in PSV, resulting in a sample of 66 participants.
Interpretation of results
his was unlikely to be the reason for the absence of significant differences in hemodynamic response among the groups. Given the multifactorial nature of the condition, expanding therapeutic options is crucial[3] so non-ablative radiofrequency therapy and combined therapy emerge as potential innovative approaches for patients with ED. Non-ablative radiofrequency therapy is widely used to stimulate collagen production, a protein present in the tunica albuginea and corpora cavernosa, which may benefit men with venoclusive ED related to aging. Shock wave therapy is well known for stimulating nitric oxide release and other factors that promote penile blood flow, facilitating erection. It is important to highlight that the majority of the sample was composed by post-prostectomized patients, who may have experienced nerve damage due to surgery, this could have contributed to the lack of a possible not positive result on hemodynamic response to the conservative treatment tested by the study.