Study of RestoreX Penile Traction Device to Preserve Erectile Function After Robotic Prostate Surgery in Men

What this Trial Is About

This research aims to evaluate the effectiveness of the RestoreX penile traction device in preserving erectile function in men undergoing robotic-assisted prostatectomy with bilateral nerve preservation and moderate or better baseline erectile function. The study addresses the challenge of erectile dysfunction following prostate cancer surgery, a problem without effective preventative treatments, by comparing erectile function outcomes at 6 months between groups using the device or not. It builds on previous smaller trials that suggested potential benefits of RestoreX in erectile function and penile length preservation. Participants will be randomly assigned to either use the RestoreX device starting one month after surgery for 30-60 minutes daily, 5-7 days per week, continuing until 6 months, or to a control group that does not use the device during this period. After 6 months, all participants may choose to use the device openly for an additional 3 months. Only the straight traction feature of the device will be used during the study. Throughout the study, men will undergo assessments of erectile function and other related measures using questionnaires at 3, 6, and 9 months post-surgery. Researchers will monitor changes in erectile function scores as the primary outcome at 6 months, along with secondary outcomes including additional questionnaire domains and adverse events over 9 months. The study duration is planned for 3 years to allow for enrollment and follow-up, with safety and effectiveness carefully tracked during and after treatment phases.

Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy