RestoreX IPP

STUDY BASICS

Do you have a diagnosis of erectile dysfunction? Are you planning to have an implantation of an inflatable penile prosthesis? You may be eligible for a research study to determine whether or not it is feasible to use a penile traction therapy device known as RestoreX prior to implantation of a penile prosthesis to potentially increase the length of the implant used during surgery.

STUDY PURPOSE

The goal of this study is to determine whether or not it is feasible to use a penile traction therapy device known as RestoreX prior to implantation of a penile prosthesis to potentially increase the length of the implant used during surgery. The device used in this study is commercially available and has been used successfully to facilitate penile lengthening in patients with diabetes and after a certain type of prostate surgery. Use of the device has not been shown to have any detrimental effects on sexual or overall health.

COULD THIS STUDY BE RIGHT FOR YOU?

Adult male patients aged 18 or greater who:
• Have a documented diagnosis of erectile dysfunction
• Are to be scheduled for a planned standard of care implantation of an inflatable penile prosthesis

WHAT PARTICIPANTS CAN EXPECT

Your study participation is expected to last 6-8 months from the date you agree to participate. If you are assigned to the group that will receive the RestoreX device, you will undergo traction therapy for three months, followed by prosthesis placement and 3 months of follow up. Being assigned to this group will cause a brief delay in surgery scheduling due to the three months of device use, but the delay should be minimal, as these surgeries are usually scheduled three months ahead. If you are assigned to the group that does not receive the device, you will undergo surgery at the next available surgical appointment and will be followed for 3 months after your surgery. We will tell you about any new information that may affect your willingness to stay in the research study.