Study of Extracorporeal Shockwave Therapy for Treating Erectile Dysfunction in Adult Men

What this Trial Is About

This research evaluates the use of low-intensity shockwave therapy LI-SWT as a treatment for men with erectile dysfunction ED, a condition where it is difficult to achieve or maintain an erection firm enough for sex. The study aims to gather information on which patients benefit from this therapy to better predict outcomes and help guide treatment decisions. The device used has FDA clearance but is not yet approved specifically for ED treatment. Participants will receive six weekly sessions of LI-SWT using the UroGold100 device, which applies shockwave energy to the penis and perineum. Before treatment, patients complete questionnaires, blood tests, and a non-invasive blood vessel function test with the EndoPAT device. Follow-up visits occur at 3, 6, and 12 months after the initial baseline visit, including additional questionnaires and safety surveys. During the study, researchers will monitor erectile function using the International Index of Erectile Dysfunction-Erectile Function Domain IIEF-EFD score, focusing on changes three months after treatment and durability of improvement at six and twelve months. Safety and any adverse effects will be assessed throughout. Total study participation includes baseline assessments, treatment sessions, and follow-up evaluations over one year.

A Single Arm Study of Extracorporeal Shockwave Therapy for Management of Erectile Dysfunction