Ortac M. et al., 2021: The Impact of Extracorporeal Shock Wave Therapy (ESWT) for the Treatment of Young Patients with Vasculogenic Mild-Erectile Dysfunction (ED): A Prospective Randomized Single-Blind, Sham Controlled Study
Ortac M, Özmez A, Cilesiz NC, Demirelli E, Kadıoğlu A.
Urology Department, Faculty of Medicine, Istanbul University, Istanbul, Turkey.
Abstract
Background: Low-intensity extracorporeal shock wave therapy (ESWT) for the treatment of vasculogenic erectile dysfunction (ED) has emerged as a promising method directly targeting the underlying pathophysiology of the disease.
Objectives: To compare outcomes in ED patients after ESWT and placebo treatment.
Materials and methods: Prospective randomized placebo-controlled single-blinded trial on 66 patients with mild ED. The study comprised a 4-week washout phase, a 4-week treatment phase, and a 48-week follow-up. Inclusion criteria included age between 18 and 75 years and diagnosis of mild ED (IIEF-EF score= 17-25) being made at least six months prior to study inclusion and being confirmed by Penile Doppler ultrasonography (US) at baseline examination. Efficacy endpoints were changes from baseline in patient-reported outcomes of erectile function(International Index of Erectile Function domain scores [IIEF-EF]), as well as erection hardness and duration (Sexual Encounter Profile diary [SEP] and Global Assessment Questions [GAQ]). Safety was assessed throughout the study.
Results: A total of 66 enrolled patients were allocated to ESWT (n=44) or placebo (n=22). Mean age of ESWT and placebo group were 42.32 ± 9.88 and 39.86 ± 11.64 (p=0.374) respectively. Mean baseline IIEF-EF scores of ESWT group and placebo were 20.32±2.32 and 19.68±1.55 respectively (p = 0.34). At 3-months follow-up, mean IIEF-EF scores were significantly higher in ESWT patients than in placebo patients (23.10 ± 2.82 vs. 20.95 ± 2.19, p = 0.003), and IIEF-EF scores of ESWT patients remained high during the 6- months (22.67 ± 3.35 vs. 19.82 ± 1.56) follow-up. The percentage of patients reporting both successful penetration (SEP2) and intercourse (SEP3) in more than 50% of attempts was significantly higher in ESWT-treated patients than in placebo patients (p = 0.001). A minimal clinically important difference between the IIEF=EF baseline and 3-months follow-up was found in 74 % of ESWT and 36 % of placebo. No serious adverse events were reported.
Discussion: and Conclusion ESWT significantly improved the erectile function of relatively young patients with vasculogenic mild ED when compared to placebo, and the beneficial effect of this treatment up to 6 months. These findings suggest that ESWT could be a useful treatment option in vasculogenic ED.
Andrology. 2021 Mar 29. doi: 10.1111/andr.13007. Online ahead of print. PMID: 33780173.
Comments 1
This report reflects and gives support to the increasing popularity of treating erectile dysfunction (ED) with ESWT. It is of note, however, that for this form of treatment there is no consensus on how it should be carried out. There seems to be as many treatment strategies as there are clinics in which ESWT is part of the therapeutic programme.
In this randomized placebo-controlled study comprising 66 young men with mild ED, ESWT was given to 44 men whereas the remaining 22 were treated in the same way but without transmission of shockwaves.
Four ESWL sessions were carried out during a period of 4 weeks (1/w). In total 3000 shockwaves were delivered to TEN positions on the penis shaft and crura. Shockwaves were generated by Duolith SD1 (Storz Medical) at a frequency of 5 Hz and an energy level of 0.20 mJ/mm2.
The effect was evaluated with IIEF-EF scores that were significantly better in the ESWT group than in the placebo treated men. It is of interest to note that the effect remained during 6 months after the treatment period. Moreover, it was observed that the effect after 6 months was less obvious in men with BMI≥30, age >35 and an ED history exceeding 12 months.
The bottom-line is that ESWT seems to be useful for treating young patients with mild ED, but it is also evident that the selection of patients is of fundamental importance. Moreover, it is necessary to define a common effective strategy on how ESWT best should be carried out.
Hans-Göran Tiselius