HEMODYNAMIC RESPONSE IN MEN WITH ERECTILE DYSFUNCTION: RANDOMIZED CLINICAL TRIAL

Santos N1, Guimarães N2, Amaral L3, Almendra N4, Ramos E4, Machado J4, Cerqueira M2, Mamede C5, Sodré P2, Mamede T3, Brasil C6, Pavie M7, Santos C5, Sodré D7, Lemos A6, Januário P8, Teles A2, Lordelo P3

Research Type

Clinical

Abstract Category

Male Sexual Dysfunction

Abstract 466
Open Discussion ePosters
Scientific Open Discussion Session 103
Thursday 18th September 2025
15:40 - 15:45 (ePoster Station 1)
Exhibition
Conservative Treatment Sexual Dysfunction Physiotherapy Clinical Trial
1. Universidade do Estado da Bahia - UNEB; Instituto Patricia Lordelo – IPL, 2. Instituto Patricia Lordelo - IPL, 3. Escola Bahiana de Medicina e Saúde Pública - EBMSP; Instituto Patricia Lordelo – IPL, 4. Instituto Patricia Lordelo – IPL, 5. Escola Bahiana de Medicina e Saúde Pública - EBMSP; Universidade do Estado da Bahia - UNEB; Instituto Patricia Lordelo - IPL, 6. Escola Bahiana de Medicina e Saúde Pública - EBMSP; União Metropolitana de Educação e Cultura - UNIME; Instituto Patricia Lordelo – IPL, 7. Universidade Salvador - UNIFACS; Instituto Patricia Lordelo – IPL, 8. Universidade do Estado da Bahia
Presenter
Links

Abstract

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.
Results
The sample was consisted of 64 patients. The groups exhibited homogeneous sociodemographic and clinical characteristics (Table 1). Intergroup and intragroup analysis did not indicate significant improvement (p>0.05) (Table 2).
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.
Concluding message
The conservative approaches investigated in this study did not demonstrate efficacy in improving the hemodynamic response in men with ED. However, further research is necessary to enhance knowledge and benefit patients who do not respond adequately to conventional treatments.
Figure 1 Table 1 - Comparison of sociodemographic and clinical characteristics.
Figure 2 Table 2 - Intragroup and Intergroup Comparisons of Peak Systolic Velocity and End-Diastolic Velocity at Baseline and After 12 Sessions.
References
  1. Liu K, Wang Z, Liu Y, Zhu P, Zhang S, Lu S et al. An Electrophysiological Technique to Accurately Diagnose and Treat Erectile Dysfunction. J. Vis. Exp. 2022 Nov 4:(189). doi: 10.3791/63851.
  2. Kalyvianakis D, Hatzichristou D. Low-Intensity Shockwave Therapy Improves Hemodynamic Parameters in Patients With Vasculogenic Erectile Dysfunction: A Triplex Ultrasonography-Based Sham-Controlled Trial. J Sex Med [Internet]. 2017;14(7):891–7. doi: 10.1016/j.jsxm.2017.05.012
  3. Hatzimouratidis K, Amar E, Eardley I, Giuliano F, Hatzichristou D et al. Guidelines on male sexual dysfunction: erectile dysfunction and premature ejaculation. Eur Urol. 2010;57:804–814. doi: 10.1016/j.eururo.2010.02.020.
Disclosures
Funding None Clinical Trial Yes Registration Number ClinicalTrial.gov, NCT04885101 RCT Yes Subjects Human Ethics Committee Research Ethics Committee of the Bahiana School of Medicine and Public Health Helsinki Yes Informed Consent Yes
02/07/2025 11:19:53