Phase II Randomized, Clinical Trial Evaluating 2 Schedules of Low-Intensity Shockwave Therapy for the Treatment of Erectile Dysfunction

Premal Patel; Jonathan Katz; Soum D Lokeshwar; Manuel Molina; Isildinha M Reis; Raul Clavijo; Ranjith Ramasamy

doi:10.1016/j.esxm.2020.01.010

Phase II Randomized, Clinical Trial Evaluating 2 Schedules of Low-Intensity Shockwave Therapy for the Treatment of Erectile Dysfunction

Sex Med. 2020 Jun;8(2):214-222. doi: 10.1016/j.esxm.2020.01.010. Epub 2020 Mar 14.

Authors

Premal Patel¹, Jonathan Katz², Soum D Lokeshwar², Manuel Molina², Isildinha M Reis³, Raul Clavijo⁴, Ranjith Ramasamy⁵

Affiliations

¹ Section of Urology, University of Manitoba, Winnipeg, Manitoba, Canada.
² Department of Urology, University of Miami, Miller School of Medicine, Miami, FL, USA.
³ Division of Biostatistics, Department of Public Health Sciences, University of Miami, Miller School of Medicine Miami, Miami, FL, USA; Biostatistics and Bioinformatics Shared Resource, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL, USA.
⁴ Department of Urology, University of California, Davis, School of Medicine, Sacramento, CA, USA.
⁵ Department of Urology, University of Miami, Miller School of Medicine, Miami, FL, USA. Electronic address: ramasamy@miami.edu.

Abstract

Purpose: To evaluate safety and clinical response of Low-intensity Shockwave Therapy (Li-SWT) for the treatment of erectile dysfunction.

Materials & methods: A single-institution, 2 arm, phase II randomized clinical trial was conducted between February 2017 and April 2019. Patients were randomized into 2 groups, with Li-SWT delivering a total of 3,600 shocks over 5 days (720 once a day, Group A) or over 2 weeks (600 once a day, 3 times a week, Group B). Patients were evaluated for the safety of therapy and completed the International Index of Erectile Function-Erectile Function domain and the Erectile Hardness Scale assessment at baseline, and at 1, 3, and 6 months visits.

Results: Among 87 evaluable patients, 45 and 42 were allocated to Groups A and B treatment schedules, respectively, and 80 patients (40 per group) completed the 6-month evaluation. No adverse events were reported during treatment or during follow-up. There were statistically significant (P < .05) improvements in International Index of Erectile Function-Erectile Function score (mean increase of 2.7 [95% CI = 1.2, 4.2] and 2.7 points [95% CI = 1.4, 4.1] for Groups A and B, respectively) and in Erectile Hardness Scale (mean increase of 0.6 points (95% CI = 0.3, 0.8) and 0.5 (95% CI = 0.2, 0.8) for Groups A and B, respectively) at 6 months, with no differences between groups.

Conclusion: No difference in outcomes was found when Li-SWT 3,600 shocks were delivered over 1 or 2 weeks at 6 months follow-up and both schedules were safe with no adverse events during or after treatment. Further trials with longer follow-up and sham arm will provide valuable information regarding treatment efficacy and durability. Patel P, Katz J, Lokeshwar SD, et al. Phase II Randomized, Clinical Trial Evaluating 2 Schedules of Low-Intensity Shockwave Therapy for the Treatment of Erectile Dysfunction. Sex Med 2020;8:214-222.

Keywords: Clinical Trial; Erectile Dysfunction; Low-Intensity Shockwave Therapy; Restorative Therapy.