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

Inclusion criteria

• Men of ages between 30-75 years with indication for nerve-sparing prostatectomy surgery;
• Cancer stage T1c and T2a;
• Grade Groups 1 and 2 as well as low volume Grade Group 3 (Gleason score 4 + 3 = 7), as determined by biopsy (2 cores or less GG3) or single index MRI lesion of GG3 disease;
• IIEF-15 erectile function domain score equal to or greater than 26;
• 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 erectile function domain score less than 26;
• Failure to demonstrate adequate nocturne erectile function prioi prostatectomy (nocturnal RigiScan measure);
• Men with PSA > 20 ng/mL;
• History of ED, 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).