(231) Low-Intensity Extracorporeal Shockwave Therapy Twice Per Week for Six Weeks May Result in Transient Subjective Improvements in Erectile Function

Abstract

Abstract Introduction Low-intensity extracorporeal shockwave therapy (LiESWT) has been reported to result in subjective improvements in erectile function, but the ideal patient population and treatment protocol have not yet been established. Objective We aimed to assess improvements in International Index of Erectile Function – Erectile Function domain (IIEF-EF) scores following treatment with LiESWT of 1500 shocks of 0.2mJ/mm2 per treatment, twice a week for six weeks. We hypothesized that LiESWT results in subjective improvements of erectile function. Methods Patients were prospectively enrolled in a clinical trial examining changes in erectile function following LiESWT. The study was powered to detect a change in IIEF-EF scores of 5 points. Patients received 12 bi-weekly LiESWT treatments of 0.2mJ/mm2 at 5Hz, 1500 shocks delivered per treatment using the Storz Duolith T-Top Ultra shockwave device. Patients completed IIEF-EF, Sexual Encounter Profile (SEP) questions two and three, Global Assessment Questions (GAQ), and Erection Hardness Score (EHS) questionnaires prior to initiation of treatments and following completion of treatments at 1-2 weeks, 4-6 weeks, 3 months and 6 months post-treatment. Changes in questionnaire responses were compared to baseline responses. Data were analyzed using single variant one-tailed T-tests and one-tailed Fisher’s exact test. Values are reported as means ± standard error. Results Twenty-five patients completed all five study visits. Mean pre-treatment IIEF-EF score was 14.24 ± 1.21. Mean IIEF-EF scores increased to 15.80 ± 1.46 1-2 weeks following treatment (Study Time #2), 16.12 ± 1.46 4-6 weeks following treatment (Study Time #3), 18.12 ± 1.57 3 months following treatment (Study Time #4), and 16.36 ± 1.86 6 months following treatment (Study Time #5), though results only reached significance at Study Time #4 (p=0.016) and results were not sustained. Changes in IIEF-EF scores following treatment were evaluated by baseline ED severity (normal IIEF-EF 26-30, N=1; mild IIEF-EF 22-25, N=2; mild-moderate IIEF-EF 17-21, N=7; moderate IIEF-EF 11-16, N=10; severe IIEF-EF 6-10, N=5. Patients with IIEF-EF scores 11-21 reported significant improvements in IIEF-EF scores at all time points (Figure 1). Mean pre-treatment EHS score was 2.1±0.14. There was no significant improvement in EHS score following treatment at any time point, and no differences when analyzed based on pre-treatment ED severity. Similarly, no changes in SEP or GAQ positive response rates were noted following treatment. Conclusions Our results suggest that LiESWT using 1500 shocks per treatment with energy of 0.2mJ/mm2 twice per week for 6 weeks may transiently improve subjective erectile function as measured using IIEF-EF questionnaires, particularly for patients with mild-moderate to moderately severe ED, consistent with other studies. However, improvements may not be sustained 6 months following treatment. Disclosure No.