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JU INSIGHT: The Effect of Low-Intensity Shock Wave Therapy on Moderate Erectile Dysfunction: A Double-Blind, Randomized, Sham-Controlled Clinical Trial
By: Dimitrios Kalyvianakis, MD, PhD; Ioannis Mykoniatis, MD, MSc, PhD; Nikolaos Pyrgidis, MD, MSc; Paraskeui Kapoteli, MSc; Filimon Zilotis, MSc; Agrippina Fournaraki, MSc; Dimitrios Hatzichristou, MD, PhD | Posted on: 01 Aug 2022
Kalyvianakis D, Mykoniatis I, Pyrgidis N et al: The effect of low-intensity shock wave therapy on moderate erectile dysfunction: a double-blind, randomized, sham-controlled clinical trial. J Urol 2022; 208: 388.
Study Need and Importance
The role of low-intensity shock wave therapy in patients with moderate erectile dysfunction remains uncaptured. In this context, we performed the first double-blind, randomized, sham-controlled trial to evaluate the efficacy and safety of low-intensity shock wave therapy exclusively in patients with moderate vasculogenic erectile dysfunction.
What We Found
Twelve sessions of low-intensity shock wave therapy twice weekly for 6 weeks with a treatment protocol of 5,000 impulses, 0.096 mJ/mm2 energy flux density and 5 Hz frequency using the ARIES 2™ device are highly effective in patients with moderate vasculogenic erectile dysfunction and previous good or partial response to phosphodiesterase type 5 inhibitors. Compared to sham therapy, the proportion of participants attaining a minimal clinically important difference in the International Index of Erectile Function–Erectile Function domain, as well as the mean change from baseline in the International Index of Erectile Function–Erectile Function domain and in the “yes” responses to question 3 of Sexual Encounter Profile diaries significantly improved at 1 and 3 months after low-intensity shock wave therapy (see Table).
Table. Comparison of changes from baseline in the International Index of Erectile Function–Erectile Function domain and question 3 of the Sexual Encounter Profile diaries after low-intensity therapy versus sham therapy adjusted for baseline values
| Parameter | Mean±SD Low-Intensity Shock Wave Therapy | Mean±SD Sham Therapy | Mean Difference (95% CI) | Between-Group p Value |
|---|---|---|---|---|
| International Index of Erectile Function–Erectile Function domain: Baseline’1 mo Baseline’3 mos |
4.9±3 5.7±2.3 |
0.9±2 1.2±1.6 |
3.9 (2.7 to 5.2) 4.4 (3.4 to 5.4) |
<0.001 <0.001 |
| Sexual Encounter Profile question 3 (yes %): Baseline’1 mo Baseline’3 mos |
21±22 28±25 |
−2.1±15 1.5±16 |
19 (11 to 27) 23 (14 to 32) |
<0.001 <0.001 |
| The analysis of covariance (ANCOVA) was applied. Bold type indicates statistically significant p values. | ||||
Limitations
Due to the single-center design of our study and the eligibility criteria restricted to patients with moderate erectile dysfunction, we included a rather small number of patients. Additionally, the relatively short followup duration of our study did not permit us to assess the long-term efficacy of low-intensity shock wave therapy, as well as the duration of the positive effect of low-intensity shock wave therapy in patients with moderate vasculogenic erectile dysfunction. Importantly, since we applied a specific low-intensity shock wave therapy protocol, our results may not be extrapolated to other low-intensity shock wave therapy generator systems or protocols.
Interpretation for Patient Care
Our findings suggest that low-intensity shock wave therapy is highly effective and safe in patients with moderate vasculogenic erectile dysfunction.
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