Retrospective Comparison of Focused Shockwave Therapy and Radial Wave Therapy for Men With Erectile Dysfunction

Shannon S. Wu; Kyle J. Ericson; Daniel A. Shoskes

Disclosures

Transl Androl Urol. 2020;9(5):2122-2128. 

In This Article

Methods

We performed an IRB approved retrospective review of all men with ED that were treated with either fSWT or rWT outside of other existing SWT research protocols between 2017 and 2019 at our institution in two clinical locations. 48 patients included in the study were evaluated by a single urologist (DS). The use fSWT or rWT was dictated by clinic location where the treatment was administered; the fSWT machine was located at one outpatient clinic location and the rWT machine at another, neither the patients nor the urologist chose the SWT modality. Patients were excluded from analysis if they had ED of known neurologic cause (e.g., post radical prostatectomy), untreated hypogonadism, or a clinical diagnosis of psychogenic ED. rWT was performed using the Zimmer enPuls Pro (Zimmer MedizinSysteme GmbH, Neu-Ulm, Germany), which utilizes an electromagnetically produced radial pulse. fSWT was performed using the UroGold 100TM (Tissue Regeneration Technologies LLC, Woodstock, Georgia), which utilizes an electrohydraulic pulse generator. In both groups, patients underwent six consecutive weekly treatments using the settings recommended by the manufacturer. The fSWT regimen entailed 3,000 shocks per session at 0.09 mJ/mm2. The rWT regimen entailed 10,000 shocks per session at 15 Hz and 90 mJ. The penis was manually, gently stretched for delivery of shockwaves to six treatment sites: one at each crus of the penis on the perineum and two locations on the shaft bilaterally. The study was conformed to the provisions of the Declaration of Helsinki (as revised in 2013). This study was reviewed and approved by the Cleveland Clinic Institutional Review Board (IRB No. 12–118). Informed consent was waived for this retrospective study as no direct interventions to the patient were present.

To assess the efficacy of treatment, pre-treatment and 6-week post-treatment Sexual Health Inventory in Men (SHIM) scores[20] were obtained by survey in clinic.[20] At 6 weeks post-treatment, men were also asked whether their erections were sufficient for penetration and whether they required phosphodiesterase 5 inhibitors (PDE5i) to achieve an erection sufficient for penetration. Patients were instructed to try PDE5i if they did not have full erections after SWT. Those who did not already have a supply received a prescription from the study investigators. These responses were graded as follows: 1 if erections insufficient for penetration, 2 if erections were sufficient for penetration with the assistance of PDE5i, and 3 if erections were sufficient without requiring PDE5i. The secondary endpoint is a self-reported improvement of grade 2 or greater.

To assess the efficacy of rWT and fSWT we compared the pre- and post-treatment SHIM scores. The mean change in SHIM scores (delta SHIM) and the proportion of men achieving a grade 2 or better response between the two treatment groups (i.e., erections sufficient for penetration with or without PDE5i) were compared. Potential confounders include placebo effect due to nature of the intervention requiring a generator.

Statistical Analysis

Intra-group comparisons of continuous data were made with a paired t-test, while an unpaired t-test was used for inter-group comparisons. Categorical data was compared with a chi-squared test. P values <0.05 were considered statistically significant. Statistical analyses were performed using SPSS version 23.0 (IBM, Armonk, New York, USA).

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