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.
International journal of impotence research. 2019 Jan 22 [Epub ahead of print]
Premal Patel, Chun Huang, Manuel Molina, Ranjith Ramasamy
Department of Urology, University of Miami, Miami, FL, USA., Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Department of Urology, University of Miami, Miami, FL, USA. .