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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

Sandoval-Salinas C, Saffon JP, Martínez JM, Corredor HA, Gallego A.
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. 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.
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 Thursday, 12 May 2022 10:15

Erectile Dysfunction has been treated successfully by use of low-intensity shock waves (LI-ESWT). Recently radial pressures waves have shown positive effects for orthopedic indications like insertion tendinitis. Definitively, the mode of action differs between focalized shock waves and radial pressure waves: In shockwaves, a soundwave is generated with a speed faster than the local speed of sound. Importantly, radial pressure waves do not behave the same as conventional shockwaves and are more like “ordinary” sound waves in that they achieve a significantly lower peak pressure, a slower rise time, and propagate outwards without a focal point. Nevertheless, there have been reports on positive effect of radial pressure waves on erectile dysfunction. This interesting article presents a double-blinded randomized study to compare the effect of radial pressure waves versus placebo (i.e. sham therapy).

Radial pressure 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 bilateral ischiocavernosus and bulbospongiosus muscles at 2.4 Bar and a frequency of 17 Hz. The sham therapy group received 6 weekly sessions under the same parameters of radial wave therapy, using an internal metal bar in the handpiece of the equipment that prevented the wave produced from reaching the tip of the handpiece and passing to the patient, but that produced the same sound of the real waves so that it was not possible to differentiate between the 2 types of waves (Masterpuls MP50; Storz-Medical. Kreuzlingen, Switzerland). All patients received Sildenafil 25 mg daily.

A total of 80 patients were randomized (1:1) with similar co-morbidities in both arms. Patients were followed over a 2 years period. The analysis did not reveal any difference between both groups using the International Index of Erectile Function (IIEF-EF score) : improvement 3.4 vs 4.2) and the Erection Hardness Score (EHS-categories): improvement 36.8 vs 41.7%).

This is a very important negative study for the use of radial pressure waves for treatment of erectile dysfunction. The sham group / Placebo was carefully designed. The only remaining problem might be the absolute lack of pain in the control group, however, when using radial pressure waves at this energy level, this might be irrelevant.

Urologists know the principle of radial pressure waves from the ballistic endoscopic lithotripters (ie. Lithoclast, EMS, Kreuzlingen, Switzerland). This may induce fragmentation of a urinary stone by direct contact, but has limited biological effects compared to focused shock waves. Even, if other reports have shown some effect on non-responders to 5-PDE-inhibitors, the actual study provides an excellent design. The effect of radial waves might help against pain similar to acupuncture, but not be able to induce functional changes of the corpus cavernosum. The only limitation represents the fact, that the patients received in addition sildenafil, thus two treatment options have been applied. However, this has been already also part of protocols using Li-ESWT. Moreover, the authors argue, that most patients would have taken 5-PDE-inhibitors anyway.

Erectile Dysfunction has been treated successfully by use of low-intensity shock waves (LI-ESWT). Recently radial pressures waves have shown positive effects for orthopedic indications like insertion tendinitis. Definitively, the mode of action differs between focalized shock waves and radial pressure waves: In shockwaves, a soundwave is generated with a speed faster than the local speed of sound. Importantly, radial pressure waves do not behave the same as conventional shockwaves and are more like “ordinary” sound waves in that they achieve a significantly lower peak pressure, a slower rise time, and propagate outwards without a focal point. Nevertheless, there have been reports on positive effect of radial pressure waves on erectile dysfunction. This interesting article presents a double-blinded randomized study to compare the effect of radial pressure waves versus placebo (i.e. sham therapy). Radial pressure 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 bilateral ischiocavernosus and bulbospongiosus muscles at 2.4 Bar and a frequency of 17 Hz. The sham therapy group received 6 weekly sessions under the same parameters of radial wave therapy, using an internal metal bar in the handpiece of the equipment that prevented the wave produced from reaching the tip of the handpiece and passing to the patient, but that produced the same sound of the real waves so that it was not possible to differentiate between the 2 types of waves (Masterpuls MP50; Storz-Medical. Kreuzlingen, Switzerland). All patients received Sildenafil 25 mg daily. A total of 80 patients were randomized (1:1) with similar co-morbidities in both arms. Patients were followed over a 2 years period. The analysis did not reveal any difference between both groups using the International Index of Erectile Function (IIEF-EF score) : improvement 3.4 vs 4.2) and the Erection Hardness Score (EHS-categories): improvement 36.8 vs 41.7%). This is a very important negative study for the use of radial pressure waves for treatment of erectile dysfunction. The sham group / Placebo was carefully designed. The only remaining problem might be the absolute lack of pain in the control group, however, when using radial pressure waves at this energy level, this might be irrelevant. Urologists know the principle of radial pressure waves from the ballistic endoscopic lithotripters (ie. Lithoclast, EMS, Kreuzlingen, Switzerland). This may induce fragmentation of a urinary stone by direct contact, but has limited biological effects compared to focused shock waves. Even, if other reports have shown some effect on non-responders to 5-PDE-inhibitors, the actual study provides an excellent design. The effect of radial waves might help against pain similar to acupuncture, but not be able to induce functional changes of the corpus cavernosum. The only limitation represents the fact, that the patients received in addition sildenafil, thus two treatment options have been applied. However, this has been already also part of protocols using Li-ESWT. Moreover, the authors argue, that most patients would have taken 5-PDE-inhibitors anyway.
Thursday, 18 July 2024