Is low-intensity shockwave therapy for erectile dysfunction a durable treatment option?-long-term outcomes of a randomized sham-controlled trial

Abstract

Background: Low-intensity shockwave therapy (LiSWT) is an emerging non-invasive and restorative therapy for erectile dysfunction (ED) with demonstrated efficacy and few adverse events. Although LiSWT has been shown to improve erectile function amongst men with ED, few studies have examined its long-term durability. We present the long-term results of a randomized controlled trial (RCT) assessing erectile function after LiSWT.

Methods: A total of 30 patients with baseline ED seen at the University of Virginia were randomized to LiSWT or sham treatment. Patients in the sham group crossed over at 1 month and were unblinded. After initial trial completion, patients enrolled in the long-term outcome study were considered one combined cohort. Patients were treated twice weekly for 3 consecutive weeks with a Storz^® Duolith™ device delivering 3,000 shockwaves at 0.1 mJ/mm² to the distal penis, the base of the penis, and the crura. Primary outcomes were changes in Sexual Health Inventory for Men (SHIM) and Erection Hardness Score (EHS) from baseline (3 months pre-treatment) up to 36 months post-treatment. Changes in SHIM and EHS scores were evaluated using linear mixed effects models. Patient satisfaction was assessed with the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index.

Results: The mean baseline SHIM score was 10.8±0.94. At 12-, 24-, and 36-month assessment following treatment, the mean SHIM scores were 15.6±1.27 (P<0.001), 15.0±1.14 (P<0.001), and 12.2±1.43 (P=0.31). The mean baseline EHS score was 1.87±0.17. At 12-, 24-, and 36-month assessment following treatment, the mean EHSs were 2.70±0.24 (P<0.001), 2.66±0.21 (P<0.001), and 2.29±0.26 (P=0.10). The median [interquartile range (IQR)] EDITS score was 48.9 (22.7, 74.4), indicating moderate satisfaction with LiSWT. There were no adverse events recorded.

Conclusions: Our analysis demonstrates sustained long-term improvement in erectile function after LiSWT for a heterogeneous cohort. While limited by population size, the results suggest durable improvement in erectile function for the first 2 years with a peak treatment effect at 1 year. Treatment effect appears to decline between 2 and 3 years.

Clinical trial registration: ClinicalTrials.gov, NCT04434352.

Keywords: Sexual dysfunction, physiological; erectile dysfunction (ED); extracorporeal shockwave therapy; psychological; sexual dysfunction; urogenital diseases.

Figure 1

Study protocol outlining the methodology used in the initial study and for the combined long-term follow up study data as is highlighted by the dotted box. One patient in the sham arm was lost to follow up prior to the primary outcome was able to be assessed, leaving 16 patients in the original control group. *, all participants in the combined cohort received LiSWT treatments with follow-up dated after the completion of their treatment course. LiSWT, low-intensity shockwave therapy; PDE5i, phosphodiesterase 5 inhibitor.

Figure 2

Estimated marginal mean and 95% CI of SHIM score (top) and EHS (bottom) for participants after LiSWT treatment. SHIM, Sexual Health Inventory for Men; EHS, Erection Hardness Score; LiSWT, low-intensity shockwave therapy; CI, confidence interval; m, months; y, years.