Randomized Control Trial of Vivex Tissue for Accelerated Wound Healing Following Penile Prosthesis Placement With Follow-up
This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on men undergoing penile implant surgery for the first time. The patients are randomized in a 2:1 ratio of active to sham treatment groups.
• The patient must be willing and able to provide informed consent
• The patient is a male between \>/= 30 and =/\< 70 years of age
• The patient has ED based of International Index of Erectile Dysfunction (IIEF) scores
• The patient has been in a stable relationship for over 3 months prior to enrollment
• A minimum of 2 sexual attempts per month for at least one month prior to enrollment - as documented by IIEF
• The patient is suffering from erectile dysfunction and undergoing penile implant surgery for the first time
• IIEF-EF score between 16 and 25
• Testosterone level 300-1000 ng/dL within 1 month prior to enrollment
• A1C level \</= 7% within 1 month prior to enrollment