Are Radial Pressure Waves Effective for the Treatment of Moderate or Mild to Moderate Erectile Dysfunction? A Randomized Sham Therapy Controlled Clinical Trial.

INTRODUCTION: Radial wave therapy is commercialized as an option for the management of erectile dysfunction. However, the mechanism of action of the radial waves differs substantially from shock waves, so the evidence gathered for shock wave therapy cannot be extrapolated, and there are very few clinical trials with the radial wave. AIM: To assess the efficacy and safety of radial wave therapy compared with sham therapy for the treatment of moderate and mild to moderate erectile dysfunction. METHODS: A randomized, double-blind, sham-controlled clinical trial was realized. Eighty patients with moderate erectile dysfunction, without sickle cell anemia, anticoagulation treatment, comorbidities, or conditions associated with secondary erectile dysfunction were included. The efficacy and safety were assessed at 6 and 10 weeks after randomization. Patients were randomized 1:1 to 1 of 2 arms: (i) 6 weekly sessions of radial wave therapy (RW group) or (ii) 6 weekly sessions of sham therapy (control group). All patients received sildenafil 25 mg. OUTCOME: The primary outcome was the mean change in the International Index of Erectile Function - Erectile Function (IIEF-EF) domain score at 6 weeks after randomization. RESULTS: Eighty men were randomized. The average baseline IIEF-EF score was 16.3 (Standard Deviation - SD 3.2), and the median baseline Erection Hardness Score (EHS) was 3 (IQR 1). At 6 weeks after randomization, the mean change in the IIEF-EF score was 3.4 (95% confidence interval [CI] 1.5-5.2) in the RW group and 4.2 (95% CI 2.5-5.9) in the control group. No differences were observed between groups (P value =.742). No change was observed in the median EHS score in the evaluations. No serious adverse events occurred in 2 (5%) patients after radial wave therapy, and in 1 (2.5%) patient after sham therapy. CLINICAL IMPLICATIONS: Knowledge of the effectiveness of radial waves protocols used for the treatment of moderate erectile dysfunction, helps doctors and patients in making decisions about the use of this therapy. STRENGTHS & LIMITATIONS: One strength is conducting the study with high methodological standards to minimize risk biases. Our results are limited to the evaluation of 1 specific protocol in moderate and mild to moderate erectile dysfunction. CONCLUSIONS: No difference was found in this study between men with moderate and mild to moderate erectile dysfunction treated with radial waves and men treated with placebo sham therapy. Studies with different protocols of radial waves are necessary. Sandoval-Salinas C, Saffon JP, Martínez JM, et al. Are Radial Pressure Waves Effective for the Treatment of Moderate or Mild to Moderate Erectile Dysfunction? A Randomized Sham Therapy Controlled Clinical Trial. J Sex Med 2022;19:738-744.

Are Radial Pressure Waves Effective in Treating Erectile Dysfunction? A Systematic Review of Preclinical and Clinical Studies.

INTRODUCTION: Radial waves are used to treat erectile dysfunction; however, they are different than focal waves, and their mechanism of action or effect on improving this condition is not known. AIM: To evaluate the effect of radial waves at the cellular level and their effectiveness at the clinical level for the treatment of erectile dysfunction. METHODS: Systematic literature review. Electronic database searches and manual searches were performed to identify (i) clinical trials or cohort studies evaluating the effectiveness of radial waves in men with erectile dysfunction and (ii) preclinical trials in animal models or cell cultures in which the production of nitric oxide or endothelial growth factor was evaluated. Study quality was assessed, and data were extracted from each study. A narrative synthesis of the results was performed given the high heterogeneity between the selected studies. MAIN OUTCOMES MEASURES: Nitric oxide production, endothelial growth factor expression, and changes in the Erection Hardness Score (EHS) and the International Index of Erectile Function (IIEF) Questionnaire score. RESULTS: Four studies in animal models and 1 randomized clinical trial in men with erectile dysfunction and kidney transplantation were identified that met the selection criteria. Preclinical studies in animals suggest that radial waves increase cellular apoptosis in penile tissue, while vascular endothelial growth factor expression increases in brain tissue. In men with erectile dysfunction, no differences were found between radial wave therapy and placebo therapy in the mean IIEF score (15.6 ± 6.1 vs 16.6 ± 5.4 at 1 month after treatment), EHS (2.5 ± 0.85 vs 2.4 ± 0.7 at 1 month after treatment), or penile Doppler parameters. CONCLUSIONS: No quality evidence was found to support the use of radial waves in humans for the treatment of erectile dysfunction. In animal models and at the cellular level, the results are contradictory. More research is needed. Sandoval-Salinas C, Saffon JP, Corredor HA, et al. Are Radial Pressure Waves Effective in Treating Erectile Dysfunction? A Systematic Review of Preclinical and Clinical Studies. Sex Med 2021;9:100393.

Prevalencia y asociación de factores de riesgo cardiovascular en hombres con disfunción eréctil / Prevalence and association with cardiovascular risk in men with erectile dysfunction

Resumen Objetivo: estimar la prevalencia de los factores de riesgo para enfermedad cardiovascular en hombres con disfunción eréctil atendidos en un centro especializado en diferentes ciudades de Colombia y evaluar su asociación con el grado de severidad de la enfermedad. Métodos: estudio de corte transversal analítico. Se revisaron los registros clínicos de pacientes con diagnóstico de disfunción eréctil que fueron atendidos durante el primer semestre del año 2018. Se analizaron las características sociodemográficas y clínicas de los pacientes, y se estimó la prevalencia de los factores de riesgo cardiovascular. Se exploró la asociación entre estos factores y el grado de severidad de la disfunción eréctil por medio de modelos multivariados logísticos ordinales. Resultados: se incluyeron 2.484 pacientes que cumplieron los criterios de selección, con una edad promedio de 48,7 años (± 14,1). 2.112 sujetos presentaron uno o más factores de riesgo cardiovascular, para una prevalencia global de 85,2%. La prevalencia estimada para factor evaluado fue la siguiente: sobrepeso y obesidad 70,9%, edad superior a 45 años 60,0%, hiperlipidemia 25,1%, hipertensión 21,4%, consumo de tabaco 17,7%, diabetes 16,7%, infarto agudo de miocardio 2,21% y antecedente de alguna enfermedad cardiovascular diferente a infarto 1,68%. En el análisis multivariado se observó que la diabetes y la edad son factores que aumentan el riesgo de severidad de la disfunción eréctil. Conclusiones: es alta la prevalencia de factores de riesgo cardiovascular en hombres colombianos con disfunción eréctil. En ese sentido, el sobrepeso u obesidad es el factor modificable más frecuente en esta población. El grado de disfunción puede estar asociado con la edad y la diabetes.

Abstract Objective: To estimate the prevalence of risk factors of cardiovascular disease in men with erectile dysfunction attending a specialist clinic in different cities in Colombia, as well as their association with the level of severity of the disorder. Methods: A cross-sectional analytical study was conducted using a review of the medical records of patients diagnosed with erectile dysfunction and seen during the first six months of 2018. An analysis was made of the socio-demographic and clinical characteristics of the patients, and the prevalence of cardiovascular risk factors was calculated. The association between these factors and the level of severity of the erectile dysfunction was determined using ordinal multivariate logistic models. Results: The study included a total of 2,484 patients that met the selection criteria. The mean age was 48.7 (± 14.1) years. The majority (2.112) of subjects had one or more cardiovascular risk factors, with an overall prevalence of 85.2%. The estimated prevalence for a factor evaluated was as follows: overweight and obesity; 70.9%, age greater than 45 years; 60.0%, hyperlipidaemia; 25.1%, hypertension; 21.4%, smoking; 17.7%, diabetes; 16.7%, acute myocardial infarction; 2.21%, and a history of any cardiovascular disease other than an infarction; 1.68%. In the multivariate analysis it was observed that diabetes and age are factors that increase the risk of severity of erectile dysfunction. Conclusions: The prevalence of cardiovascular risk factors is high in Colombian men with erectile dysfunction. As regards this, overweight or obesity is the most common modifiable factor in this population. The level of dysfunction may be associated with age and diabetes.

Quality of Clinical Practice Guidelines for the Diagnosis and Treatment of Erectile Dysfunction: A Systematic Review.

INTRODUCTION: Clinical practice guidelines (CPGs) guide the diagnosis and treatment of erectile dysfunction using different methodologies. Nonetheless, the quality of published CPGs is unknown. AIM: To evaluate the quality of CPGs for diagnosis and treatment of patients with erectile dysfunction. METHODS: The Medline, Embase, and LILACS databases were searched using structured strategies. The evidence was complemented by searches on websites of scientific societies and guideline developers. The CPG quality was assessed using the Appraisal of Guidelines for Research & Evaluation (AGREE II) instrument. MAIN OUTCOME MEASURE: The outcome measure included the quality of CPGs in accordance with the AGREE II instrument score. RESULTS: 17 guidelines met the selection criteria. 15 had recommendations for diagnosis, 16, had recommendations for treatment, and 1 included a follow-up. Most of the guidelines were developed in Europe (35.3%) and North America (29.4%), 2 were prepared by specialized groups (11.7%), and 1 was funded by public resources. The most common development method was the panel of experts (9 guides, 52.9%). 5 guidelines were of high quality as per the methodological rigor, as follows: Cancer Care Ontario 2016 (76.5%), European Urology Association 2018 (65.6%), American Urological Association 2018 (62.5%), American College of Physicians (62.5%), and Japanese Society for Sexual Medicine (60.4%). There was a significant relationship (P = .043) between the methodological quality of the guidelines and the funding source. CLINICAL IMPLICATIONS: By knowing the quality of the clinical practice guidelines, users can make more objective decisions about their use, which has an impact on patient care. STRENGTH & LIMITATIONS: High-quality CPGs frequently used in health-care practice were identified. Solely CPGs in Spanish, English, and Portuguese were included, which generates selection bias in the results. CONCLUSIONS: The number of CPGs for erectile dysfunction developed using international standards that meet the AGREE II quality criteria is low. Scientific societies have a strong interest in developing guidelines on this topic, whereas the participation of governmental organizations is limited. Sandoval-Salinas C, Saffon JP, Corredor HA. Quality of Clinical Practice Guidelines for the Diagnosis and Treatment of Erectile Dysfunction: A Systematic Review. J Sex Med 2020;17:678-687.

Transcutaneous electric nerve stimulation to treat patients with premature ejaculation: phase II clinical trial.

A phase II single-arm trial was conducted from June 2017 to October 2018 to evaluate the efficacy and safety of transcutaneous posterior tibial nerve stimulation (TPTNS) for premature ejaculation (PE) treatment. Twelve men with PE and no prior treatment were enrolled, one was withdrawn and 11 subjects provided data for the main outcome. TPTNS consisted of 30-min sessions of the application of 20 Hz with a pulse amplitude of 200 µsec. The intensity was adjusted based on individual sensibility. The participants received 3 weekly sessions for 12 consecutive weeks. Follow-up continued for 9 months after therapy completion. The main outcome was a threefold increase in the intravaginal ejaculation latency time (IELT) at week 12. Eleven patients completed therapy, and 54.5% (p = 0.037) showed tripled baseline IELT scores at week 12. The IELT increased 4.8-fold, 6.8-fold, and 5.4-fold at weeks 12, 24, and 48, respectively. One episode of constipation was reported, and one patient reported a sensation of heat in the leg during one therapy session. The findings suggest that TPTNS therapy delays ejaculation in patients with lifelong premature ejaculation, with no serious secondary effects. Controlled trials with larger sample sizes are needed to verify these results.

Treatment of Priapism Secondary to Drugs for Erectile Dysfunction.

Priapism may present as a side effect in patients treated with medications for erectile dysfunction, in which it should be controlled in a timely manner to avoid complications. There is little information regarding the use of local measures for the treatment of this condition. This study was done with the objective to describe the management of priapism secondary to erectile dysfunction drugs in a cohort of men. Records of emergencies and adverse events were reviewed by two researchers to identify patients diagnosed with erectile dysfunction who received oral or intracavernosal drugs for their illness and presented priapism. Sociodemographic data, clinical background, and information on the duration, management, and evolution of the priapism were extracted. Priapism incidence, percentage of improvement by type of treatment subgroups, and frequency of complications were estimated. 698 patients were treated with PDE-5 inhibitors and 2,135 with intracavernosal drugs. Thirty-one patients (1.4%) reported at least one priapism event during treatment, all with intracavernosal drugs. Treatment with local measures was effective for 10 (32.2%) patients, 1 (3.2%) required terbutaline, 19 (61.2%) used intracavernosal etilefrine, and 1 (3.2%) required drainage and flushing of cavernous bodies. After the priapism episode, 3 (9.6%) patients required an increased dose of the drug in order to achieve satisfactory erection. The results suggest that in men treated for priapism secondary to the use of sexual impotence drugs, initial treatment with local measures and etilefrine can achieve detumescence, decreasing the need for invasive procedures or surgery as a first-line therapy alternative. It is necessary to carry out research studies to confirm this hypothesis.