Patel P et al., 2019: Clinical trial update on shockwave therapy and future of erectile function restoration
Patel P, Huang C, Molina M, Ramasamy R.
Department of Urology, University of Miami, Miami, FL, USA.
Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Our interim analysis of a phase II clinical trial on low-intensity extracorporeal shockwave therapy (Li-ESWT) for men with erectile dysfunction (ED) has demonstrated it is safe with no reported adverse outcomes. Interim analysis has demonstrated Sexual Encounter Profile 3 (ability to maintain erection till completion) was achieved in 60% of men prior to Li-ESWT, which increased to 90% after treatment. Nevertheless, limitations of our clinical trial include the lack of a sham arm and our inability to exclude men with psychogenic ED. We have begun recruitment of our phase III clinical trial that will allow assessment of treatment efficacy against a sham control arm. There exists substantial interest in the use of restorative therapies (i.e., Li-ESWT, stem cells, and platelet rich plasma) for men with ED with the potential to combine therapies to potentially lead to an augmented response.
Int J Impot Res. 2019 Jan 22. doi: 10.1038/s41443-019-0115-1. [Epub ahead of print]
The role of LI-ESWT in the clinical management of ED currently attracts a great interest in the literature as well as among practicing urologists. This report is an update on a clinical trial in which two treatment alternatives were offered to deliver a total of 3600 shockwaves: One group was treated with 720 shockwaves every day during five consecutive days whereas the other group was treated with 600 shockwaves every other day during a period of two weeks.
Increments in IIEF-score were recorded in both groups and the results up to six months were considered as encouraging. The authors emphasize however that this kind of studies also require both a sham arm and a control arm and these are planned for a planned study of the clinical role of LI-ESWT.
It is evident, however, that the effects of LI-ESWT so far are less than optimal and in this report the authors also discuss the possibility to combine LI-ESWT with intracorporeal injection of mesenchymal stem cells.
Undoubtedly the results with LI-ESWT so far are interesting and it is likely that a lot more information on the role of LI-ESWT in ED can be expected in the future.