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

Inclusion Criteria:

• Men of ages between 30-70 years;

• Men with indication for nerve-sparing prostatectomy surgery;

• Localised prostate cancer considered suitable for bilateral nerve sparingprostatectomy according to clinical criteria

• International Index of Erectile Function (IIEF-15) erectile function domain scoreequal to or greater than 26 prior prostatectomy;

• Men interested in minimizing the effect of radical prostatectomy on erectilefunction;

• Ability to read and understand patient information materials and willingness to signa 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 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 impacterectile functions;

• Identification of technical or clinical limitation to properly apply the use ofnerve-sparing techniques during operation;

• Inability to understand and demonstrate device use instructions;

• Patients with insulin-dependent diabetes who suffer peripheral neuropathy or otherdiabetes associated complications;

• Patient unwillingness to engage in sexual activity;

• Patient is currently participating in another clinical investigation that wouldserve as a contraindication to implant a neurostimulator device to augment erectilefunction;

• Have participated in any drug or device trial in the last 4 weeks or plan toparticipate in any other drug or device study during the next 24 months;

• Possess any other characteristics that, per the investigator's judgment, mayincrease the risk or impair data collection for the procedure/study;

• Patient is a member of a vulnerable population (Vulnerable participants includethose who lack consent capacity, including the mentally ill, prisoners, cognitivelyimpaired participants, and employee volunteers).