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Electrohydraulic low-intensity shockwave therapy for PDE5i-refractory erectile dysfunction: A prospective, randomized, placebo-controlled study

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Sources of Funding: None

Introduction

Animal and human studies have evaluated the role of low-intensity extracorporeal shockwave therapy (LIST) in the management of multiple disorders. LIST is thought to release angiogenic factors and recruit endothelial progenitor cells, inducing neovascularization. The aim of the study is to investigate the effects of penile LIST on erectile function in patients suffering erectile dysfunction (ED) refractory to phosphodiesterase type 5 inhibitors (PDE5i)

Methods

Prospective, randomized, simple-blind, sham-controlled study. 58 patients with vasculogenic ED refractory to PDE5i were randomized into two groups. 30 were treated with electrohydraulic LIST (1 session/week for 6 weeks; 1,500 pulses of 0.10 mJ/mm2 at 5 Hz) and 28 were treated with a sham probe. 11 patients withdrew from the study and were lost to follow-up. Patients were evaluated at baseline and 1 month after the end of treatment using validated ED questionnaires. Fisher´s exact or Student’s t-test were used. Results were considered statistically significant at p<0.05

Results

27 active-treated patients and 20 sham-treated patients completed the one-month follow-up. There was no significant difference between the two groups in baseline characteristics. Baseline five-item version of the International Index of Erectile Function (IIEF-5) mean scores, in the active and sham groups, were 10.0 ± 3.9 and 10.0 ± 4.5, respectively (p= 0.863). At baseline, 48.1% of patients in the active group and 50.0% of patients in the placebo group had a positive answer to the Sexual Encounter Profile (SEP) 2 question (p=1.000); 11.1% of patients in the active group and 10.0% of patients in the placebo group had a positive answer to the SEP 3 question (p=1.000). One month after treatment IIEF-5 scores mean changes from baseline, in the active and placebo group, were 1.6 ± 4.7 and 0.5 ± 4.4, respectively (p=0.478). SEP 3 positive responders increased by 18.5% in the active group and by 0% in the placebo group (p=0.063)

Conclusions

Electrohydraulic LIST produced non-significant changes in erectile function at one-month follow up, compared to sham treated patients. Severity of ED, type of energy, intensity, frequency of shockwaves and follow-up length, together with limited sample size, could be in part responsible for this finding. More studies with larger sample size and longer follow-up, comparing different lithotripters and shock wave protocols, are imperative to elucidate the real role of LIST in ED

Funding

None

Authors
Jose Vinay
Daniel Moreno
Alvaro Vives
Osvaldo Rajmil
Eduardo Ruiz-Castane
Josvany Sanchez-Curbelo
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