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

Research output: Contribution to journalArticlepeer-review

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;XX:XXX–XXX.

Original languageEnglish (US)
JournalSexual Medicine
DOIs
StateAccepted/In press - Jan 1 2020

Keywords

  • Clinical Trial
  • Erectile Dysfunction
  • Low-Intensity Shockwave Therapy
  • Restorative Therapy

ASJC Scopus subject areas

  • Reproductive Medicine
  • Dermatology
  • Urology
  • Behavioral Neuroscience

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