Evaluating Safety and Effectiveness of a New Implantable Device for Erectile Dysfunction after Radical Prostatectomy in Men Aged 30 to 70

What this Trial Is About

This clinical trial is focused on men experiencing erectile dysfunction after radical prostatectomy, a surgery for localized prostate cancer. Researchers aim to evaluate the safety and performance of a new implantable device designed to help with erectile function recovery. The study compares men receiving the device during nerve-sparing prostatectomy with those undergoing standard surgery without the device. The investigational device is implanted during the prostatectomy surgery and works by delivering electrical pulses to activate the pro-erectile nerves in the pelvic plexus. Participants with the device are asked to activate it daily to potentially aid in restoring natural erectile function. The control group receives the standard nerve-sparing prostatectomy without device implantation. Participants will be followed for 6 months after surgery, attending hospital visits and completing questionnaires. They will activate the device daily if implanted and measure erection hardness. Researchers will monitor adverse events, surgical complications, device performance, pain levels, and erectile function recovery. This follow-up period helps assess both safety and effectiveness of the device.

Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction