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

Launched by COMPHYA AUSTRALIA · Dec 6, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the safety and effectiveness of a new device designed to help men who experience erectile dysfunction after having surgery for prostate cancer, specifically a type called radical prostatectomy. The researchers want to find out if this device is safe to use and whether it helps improve erectile function, as well as how satisfied the men are with the device.

To participate, men aged 30 to 70 who are undergoing nerve-sparing prostate surgery for localized prostate cancer may be eligible. They should have good erectile function before surgery and be willing to follow the study guidelines. Participants will receive the device during their surgery and will need to attend follow-up visits at the hospital for six months. During this time, they will answer questionnaires, use the device daily, and report on their experiences. The study will compare the results of those with the device to those without it to evaluate its effectiveness.

Gender

MALE

Eligibility criteria

• 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 sparing prostatectomy according to clinical criteria
• • International Index of Erectile Function (IIEF-15) erectile function domain 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 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 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).