V11-02: A Randomized Clinical Trial on Safety and Efficacy of Low Intensity Shockwaves for the Treatment of Erectile Dysfunction – Comparison of Two Treatment Schedules
We aim to evaluate the safety and efficacy of low intensity shockwave treatment (LISWT) for erectile dysfunction (ED). Further, we sought to report 1 month and 3 months post-treatment follow-up data from an ongoing phase II randomized clinical trial.
Men with ED (n?=?30) between the ages of 30 and 80 years who had a baseline International Index of Erectile Function questionnaire (IIEF-EF) score between 11-26, total testosterone between 300 and 1000 ng/dL in AM, phosphodiesterase inhibitor washout period of at least 4 weeks and had 1 month follow-up data were included in this analysis. We excluded patients with previous radical prostatectomy, extensive pelvic or back surgery, HbA1c > 7.5%, or in use of antidepressants. Patients were randomized in a 1:1 ratio into two treatment schedules for a total number of 3600 shocks using the Direx Renova LISWT device. Group A received 720 shocks on a five-day consecutive treatment schedule for one week and group B received 600 shocks every other day on a 6 days schedule for two weeks. Subjects reported the IIEF and Erection Hardness Score (EHS) questionnaires at baseline, 1 month and 3 months follow up.
Mean +/- IIEF-EF score at base line was 17.5 +/- 0.8 for group A, and 17.7 +/- 1.1 for group B. 1 month follow-up group A revealed an increasing in the IIEF-EF score from 17.5 +/- 0.8 to 20.1 +/- 1.5 (p = 0.10). However, group B had a lower increase in the IIEF-EF score at 1 month follow up 17.7 +/- 1.1 to 19 +/- 1.1 (p=0.15). Mean +/- IIEF-EF score after three-month follow-up was 20.8+/- 2.5 and 22.1+/- 1.3 for group A and B respectively. Group A and B had a significant increase in the EHS-EF score at 1 month follow-up (p
Ongoing Phase II clinical trial of the effect of LISWT on ED revealed a promising effect on recovery of the erectile function at 3 months follow-up. In this interim analysis, a clinically and statistically relevant effect of LISWT was observed. Long-term follow-up is needed to determine efficacy of shockwave therapy for erectile dysfunction.