madman
Super Moderator
Abstract
Purpose Over the last decade, penile low-intensity extracorporeal shockwave therapy (LI-ESWT) has emerged as a promising alternative for the treatment of erectile dysfunction (ED). The aim of this trial is to assess the effect of electromagnetic LI-ESWT on the erectile function of vascular phosphodiesterase type 5 inhibitor (PDE5I) refractory ED patients.
Methods Randomized, double-blind, sham-controlled study. 76 patients with vascular PDE5I-refractory ED completed the study. 40 men were treated with LI-ESWT (1 session/week for 4 weeks, 5000 shocks/session, 0.09 mJ/mm2 energy density) and 36 were treated with a sham probe. Baseline and post-treatment (1, 3, and 6 months) evaluations were performed using validated erectile function questionnaires (IIEF-EF, EHS, SEP2, SEP3, and GAQ1). The groups were compared using Mann– Whitney–Wilcoxon and chi-squared tests, with results considered statistically significant at p<0.05.
Results At the 3-month follow-up, the median change in the IIEF-EF score for active and sham groups was 3.5 (IQR 0–10) and −0.5 (IQR −11 to 1), respectively (p<0.05). Six months after treatment, 52.5% of patients (21/40) in the active group and 27.8% of patients (10/36) in the sham group presented an EHS>2 (p<0.05). At the same evaluation, 40.0% (16/40) and 13.9% (5/36) of patients had positive answers to GAQ-1, in the treated and sham groups, respectively (p<0.05). No adverse events were observed during the study.
Conclusion This study showed that penile electromagnetic shockwave therapy may improve erectile function, to a modest extent, on certain patients that do not respond to PDE5I; making it an alternative for vascular ED patients that reject more invasive therapies.
*The study has several limitations. There was a limited sample size; however, this is common among LI-ESWT clinical trials. Penile hemodynamics were not measured to diagnose vasculogenic ED or to confirm the improvement of cavernous blood inflow or penile rigidity. Penile Doppler ultrasound could be considered to measure arterial inflow and venous outflow. Although 6 months of follow-up is higher than the duration of several other trials,>1 year of follow-up would be better to correctly assess the long-term effects of this therapy.
Conclusion
This randomized double-blind sham-controlled trial showed moderate improvement in different EF parameters at 3 and 6 months of follow-up. It is of the utmost importance to elaborate randomized sham-controlled studies with longer follow-ups, that compare different ED etiologies and protocol characteristics, to elucidate the real role of LI-EWST in the treatment of ED.
Purpose Over the last decade, penile low-intensity extracorporeal shockwave therapy (LI-ESWT) has emerged as a promising alternative for the treatment of erectile dysfunction (ED). The aim of this trial is to assess the effect of electromagnetic LI-ESWT on the erectile function of vascular phosphodiesterase type 5 inhibitor (PDE5I) refractory ED patients.
Methods Randomized, double-blind, sham-controlled study. 76 patients with vascular PDE5I-refractory ED completed the study. 40 men were treated with LI-ESWT (1 session/week for 4 weeks, 5000 shocks/session, 0.09 mJ/mm2 energy density) and 36 were treated with a sham probe. Baseline and post-treatment (1, 3, and 6 months) evaluations were performed using validated erectile function questionnaires (IIEF-EF, EHS, SEP2, SEP3, and GAQ1). The groups were compared using Mann– Whitney–Wilcoxon and chi-squared tests, with results considered statistically significant at p<0.05.
Results At the 3-month follow-up, the median change in the IIEF-EF score for active and sham groups was 3.5 (IQR 0–10) and −0.5 (IQR −11 to 1), respectively (p<0.05). Six months after treatment, 52.5% of patients (21/40) in the active group and 27.8% of patients (10/36) in the sham group presented an EHS>2 (p<0.05). At the same evaluation, 40.0% (16/40) and 13.9% (5/36) of patients had positive answers to GAQ-1, in the treated and sham groups, respectively (p<0.05). No adverse events were observed during the study.
Conclusion This study showed that penile electromagnetic shockwave therapy may improve erectile function, to a modest extent, on certain patients that do not respond to PDE5I; making it an alternative for vascular ED patients that reject more invasive therapies.
*The study has several limitations. There was a limited sample size; however, this is common among LI-ESWT clinical trials. Penile hemodynamics were not measured to diagnose vasculogenic ED or to confirm the improvement of cavernous blood inflow or penile rigidity. Penile Doppler ultrasound could be considered to measure arterial inflow and venous outflow. Although 6 months of follow-up is higher than the duration of several other trials,>1 year of follow-up would be better to correctly assess the long-term effects of this therapy.
Conclusion
This randomized double-blind sham-controlled trial showed moderate improvement in different EF parameters at 3 and 6 months of follow-up. It is of the utmost importance to elaborate randomized sham-controlled studies with longer follow-ups, that compare different ED etiologies and protocol characteristics, to elucidate the real role of LI-EWST in the treatment of ED.
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