A Critical Analysis of the Methodological Limitations in Trials of Low-Intensity Shockwave Therapy for Erectile Dysfunction - Expert Commentary
Salter et al, have presented a very detailed data collection of methodological limitations in the literature surrounding this technology, largely prohibiting comparisons between series that report on efficacy. They reviewed 45 clinical studies, including 20 randomized controlled trials and 25 cohort studies. The variability of the parameters shows why well-intentioned comparisons are fraught with difficulty. Nine different treatment probes were utilized; shock number per session ranged from 600-10000; session number per week ranged from 1-5; total treatment shocks ranged from 3000-90000; the number of application sites varied between 2-10.
Adequate power was not demonstrated by some studies; different durations of treatment and follow-up were employed. Looking at these data and the literature surrounding this technology prompted these authors to come up with a reasonable list of questions, which hopefully will be answered in the future: which patient populations best respond to LiSWT? Which probe and energy parameters are most effective? Which therapeutic schedule should be used? What are the optimal number and location of sites? What is the duration of response? Are maintenance treatments effective, and what should be their schedule? Those who espouse this technology should be aware of the shortcomings in the literature surrounding this subject and attempt to clarify these questions.
Written by: Alan Wein, MD, PhD, FACS, Professor of Clinical Urology, Department of Urology, Desai Sethi Urology Institute (DSUI), University of Miami Miller School of Medicine, University of Miami Health Systems, Miami, FL
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