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Sandoval-Salinas C. et al., 2022: Are Radial Pressure Waves Effective for the Treatment of Moderate or Mild to Moderate Erectile Dysfunction? A Randomized Sham Therapy Controlled Clinical Trial

Elexial research center, Bogotá, Colombia; Boston Medical Group, Bogotá, Colombia.
Elexial research center, Bogotá, Colombia; Boston Medical Group, Bogotá, Colombia.

Abstract

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.

J Sex Med. 2022 May;19(5):738-744. doi: 10.1016/j.jsxm.2022.02.010. Epub 2022 Mar 24. PMID: 35341724.

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Comments 1

Jens Rassweiler on Friday, 15 December 2023 08:45

This article presents the findings of a randomized, double-blind, parallel-group clinical trial that aimed to evaluate the efficacy and safety of radial wave therapy for the treatment of moderate and mild to moderate erectile dysfunction (ED). The study included 80 men with vascular ED and compared the effects of radial wave therapy to sham therapy. 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. The waves were administered with Masterpuls MP50 equipment. The parameters for radial wave therapy included 1 weekly session, 4,000 pulses in the body of the penis in a sweeping technique on the lateral aspect of each cavernous body from the base of the penis to the balanopreputial sulcus and 2,000 pulses in the perineal area, specifically in the bilat- eral ischiocavernosus and bulbospongiosus muscles at 2.4 Bar and a frequency of 17 Hz.

The results showed that after 6 weeks of therapy, there was no significant difference in the change of International Index of Erectile Function-Erectile Function (IIEF-EF) scores between the radial wave therapy group and the sham therapy group. The average change in the IIEF-EF score was 4.2 in the sham therapy group and 3.4 in the radial wave therapy group. These findings remained consistent at the 10-week follow-up.

Furthermore, there was no significant difference in the improvement of Erection Hardness Score (EHS) between the two groups at both 6 and 10 weeks. Adverse events were minimal, with only a few cases of facial flushing and superficial abrasions reported.

The study suggests that radial wave therapy, administered at a schedule of 6 weekly sessions at 2.4 bars, is not more effective than placebo in treating men with moderate and mild to moderate ED. The authors hypothesize that the limited penetration and biological effects of radial waves compared to focal shock waves may explain the lack of significant results.

The study has certain limitations, including the subjective nature of the questionnaires used to evaluate erectile function, a relatively short follow-up period, and the use of sildenafil by the participants, which may have influenced the outcomes. Moreover, the application mode is different from other studies using Li-ESWT. Subsequently, future studies should apply similar treatment patterns (ie. 3000 SW at six sites per 500 impulses). Additionally, for such a population the use of sildenafil should be stopped / excluded.

In conclusion, while radial wave therapy has been marketed as a treatment option for ED, this study indicates that the protocol used in this trial did not demonstrate significant efficacy in improving erectile function. Further research with different protocols, longer follow-up periods, and histological evaluations is needed to confirm these findings and explore the potential of radial wave therapy in specific populations and conditions.

This article presents the findings of a randomized, double-blind, parallel-group clinical trial that aimed to evaluate the efficacy and safety of radial wave therapy for the treatment of moderate and mild to moderate erectile dysfunction (ED). The study included 80 men with vascular ED and compared the effects of radial wave therapy to sham therapy. 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. The waves were administered with Masterpuls MP50 equipment. The parameters for radial wave therapy included 1 weekly session, 4,000 pulses in the body of the penis in a sweeping technique on the lateral aspect of each cavernous body from the base of the penis to the balanopreputial sulcus and 2,000 pulses in the perineal area, specifically in the bilat- eral ischiocavernosus and bulbospongiosus muscles at 2.4 Bar and a frequency of 17 Hz. The results showed that after 6 weeks of therapy, there was no significant difference in the change of International Index of Erectile Function-Erectile Function (IIEF-EF) scores between the radial wave therapy group and the sham therapy group. The average change in the IIEF-EF score was 4.2 in the sham therapy group and 3.4 in the radial wave therapy group. These findings remained consistent at the 10-week follow-up. Furthermore, there was no significant difference in the improvement of Erection Hardness Score (EHS) between the two groups at both 6 and 10 weeks. Adverse events were minimal, with only a few cases of facial flushing and superficial abrasions reported. The study suggests that radial wave therapy, administered at a schedule of 6 weekly sessions at 2.4 bars, is not more effective than placebo in treating men with moderate and mild to moderate ED. The authors hypothesize that the limited penetration and biological effects of radial waves compared to focal shock waves may explain the lack of significant results. The study has certain limitations, including the subjective nature of the questionnaires used to evaluate erectile function, a relatively short follow-up period, and the use of sildenafil by the participants, which may have influenced the outcomes. Moreover, the application mode is different from other studies using Li-ESWT. Subsequently, future studies should apply similar treatment patterns (ie. 3000 SW at six sites per 500 impulses). Additionally, for such a population the use of sildenafil should be stopped / excluded. In conclusion, while radial wave therapy has been marketed as a treatment option for ED, this study indicates that the protocol used in this trial did not demonstrate significant efficacy in improving erectile function. Further research with different protocols, longer follow-up periods, and histological evaluations is needed to confirm these findings and explore the potential of radial wave therapy in specific populations and conditions.
Saturday, 20 July 2024