Double-S Wearable Device to Support Men with Erectile Dysfunction Minimally Invasive Mechanical Help for Satisfactory Penetration

What this Trial Is About

This research aims to evaluate a minimally invasive wearable device designed to support men suffering from erectile dysfunction, including those with conditions such as post-prostatectomy or radiation therapy, vascular or metabolic causes, and psychological factors. The study focuses on providing a mechanical, medication-free option to help patients achieve satisfactory sexual penetration. Participants will be asked to use the Double-S wearable penile device during intercourse. This device is intended to offer support without medication, helping men with moderate to severe erectile dysfunction to engage in sexual activity. The study does not involve a control or placebo group and is open-label. During the study, researchers will assess changes in erectile function using a modified International Index of Erectile Dysfunction score from baseline up to one month after starting the device use. Participants will be monitored and evaluated based on their ability to use the device and achieve satisfactory intercourse. The total study duration and follow-up details are aligned with this assessment period.

Double-S: a Wearable Device for Erectile Dysfunction