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

Inclusion Criteria: Men of ages between 30-65 years; Men with indication for nerve-sparing prostatectomy surgery; Cancer stage T1c and T2a; Gleason score 6 or 7 (but only 3+4); International Index of Erectile Function (IIEF-15) score equal to or greater than 26 prior prostatectomy; Men interested in minimizing the effect of radical prostatectomy on erectile function; Ability to read and understand patient information materials and willingness to sign a written informed consent. Exclusion Criteria: Men with neurological disease, including a history of spinal cord injury or trauma; IIEF-15 score less than 26 prior prostatectomy; Failure to demonstrate adequate nocturnal erectile function prior prostatectomy; History of erectile dysfunction, priapism and Peyronie disease; History of previous pelvic surgery, trauma or irradiation therapy; Currently have an active implantable device; Patient diagnosed with neurologic degenerative diseases that may negatively impact erectile functions; Identification of technical or clinical limitation to properly apply the use of nerve-sparing techniques during operation; Inability to understand and demonstrate device use instructions; Patients with insulin-dependent diabetes who suffer peripheral neuropathy or other diabetes associated complications; Patient unwillingness to engage in sexual activity; Patient is currently participating in another clinical investigation that would serve as a contraindication to implant a neurostimulator device to augment erectile function; Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other drug or device study during the next 24 months; Possess any other characteristics that, per the investigator's judgment, may increase the risk or impair data collection for the procedure/study; Patient is a member of a vulnerable population (Vulnerable participants include those who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, and employee volunteers).