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.
You may not be if
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).
Clareo Health | Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction
