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.
Erectile Dysfunction (ED) is a condition with an inability to develop or maintain an erection of the penis upon sexual stimulation. It occurs in association with aging, chronic illnesses and various modifiable risk factors. Amongst the modifiable risk factors, ED shares the most common risk factors with Coronary Artery Disease (CAD) which are smoking, hypertension and hyperlipidemia. Even though it is not a part of normal aging, it is seen in 52% of men in the age group 40 to 70 years, with a higher rate in the men more than 70 years. VIAGENEX Max is a semi-transparent, collagenous membrane intended for soft tissue barrier or wound covering, derived from umbilical cord membrane. A total of 50 subjects with ED meeting the eligibility criteria will be randomized. The treatment graft will be placed into the wound at time of surgery. The treatment group will receive the VIAGENEX graft and the sham group will receive the standard of care for this surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
Collagenous membrane derived from umbilical cord
Antiseptic skin cleanser
Atlanta Cosmetic Urology
Atlanta, Georgia, United States
Penile implant activation
Time to use implant for sexual activity
Time frame: up to 3 months
Pain after undergoing penile prosthesis surgery
Numerical pain scale (0=no pain to 10=worst pain) used to
Time frame: surgery to 12 months
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