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

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).