This trial is looking to test a penile traction device (RestoreX) and how this affects the length of a penile prosthesis (implant) in men with erectile dysfunction. The main outcome to be measured is the length of the penile prosthesis implanted. This study is taking place in the U.S.
The details
Men who have erectile dysfunction are often recommended to have penile prosthesis implanted. However, the insertion of the prosthesis can often result in a shortened penile length. Penile traction therapy is thought to stop this side effect. Penile traction devices gently extend the penis to try and lengthen it. It is non-invasive, does not affect penile surgery and has minimal long-term side effects.
This study aims to test a new penile traction device (RestoreX) in men with erectile dysfunction planning a have a penile prosthesis implanted. The main outcomes of the study will be the length of the implant which can be inserted after the traction therapy and patient satisfaction.
Who are they looking for?
40 participants who are undergoing placement of a penile prosthesis are needed for this study. Participants should be undergoing implantation of a 3-piece inflatable penile prosthesis for the first time.
Participants should not have prior ischemic priapism (prolonged erection). They should not have any prior penile prosthesis surgeries, or penis surgeries other than circumcision. Participants who are undergoing malleable penile prosthesis or Ambicor devices (inflatable prosthesis) will not be recruited.
How will it work
Participants included will be randomly assigned to one of two groups. One group will receive traction therapy and one group will have no treatment before implantation of the penile prosthesis. Men using the traction device will use it for 30 minutes, three times a day for 3 months before surgery.
Length of the penis will be assessed before surgery and then 3 months after penile prosthesis implantation. Patients will be followed up to 12 months after surgery to evaluate penis length, patient satisfaction, and any side effects.
