HOW LONG THE STUDY WILL LAST AND HOW MANY PEOPLE WILL BE IN THE STUDY
The study will last 365 days. About 3000 men ages 30 through 80, are expected to be in this study.
TO BE IN THIS STUDY
You cannot be in this study if you are in another research study or if you have been in any other research study in the last 30 days.
COSTS TO BEING IN THE STUDY
Participation requires undergoing self-funded Shockwave Therapy; neither the study team nor the Sponsor will be able to fund treatment for study participants.
While participating in this research study, you will need to:
· Have a Shock Wave Therapy plan for the treatment of erectile dysfunction. A Shock Wave Therapy plan is developed by the study doctor and describes how often you receive Shock Wave Therapy.
· Be willing and able to follow the study directions and procedures
· Tell the study staff about any side effects or problems
· Ask questions as you think of them
· Tell the investigator or the study staff if you change your mind about staying in the study.
· Complete your questionnaires at Month 3, 6, 9, and 12.
WHAT WILL HAPPEN DURING THE STUDY
Before the study starts, you will be asked to sign this consent form, give your health history, and tell study staff if you take any over-the-counter or prescription medicines, vitamins or herbs.
The investigator will do some tests to find out if you can be in the study. These tests include:
· Physical exam, including vital signs (blood pressure, temperature, heart and breathing rates), height and weight
· Capture Medical History
In order to participate in this study, you must be receiving shock wave therapy to treat erectile dysfunction. The study doctor can discuss the procedure with you in more detail, but here is a brief overview:
Shock wave therapy requires that you undress from the waist down. If you desire, your penis will be numbed with an anesthetic applied to the skin. The study doctor can discuss this and other ways to numb your penis if needed. The shock waves are administered via a shock wave applicator, which is applied to the penis. The study doctor will decide on the best spot to put the shock wave applicator on your penis. After the procedure you will dress and can leave immediately. The numbing medicine wears off in a couple hours and you are free to engage in intercourse that night.
POSSIBLE SIDE EFFECTS AND RISKS
If you do not understand what any of these side effects mean, please ask the investigator or study staff to explain these terms to you.
Because this device/procedure is investigational, all of its side effects may not be known. There may be rare and unknown side effects. Some of these may be life threatening.
You must tell the investigator or study staff about all side effects that you have. If you are not honest about your side effects, you may harm yourself by staying in this study.
The majority of side effects are reported to occur within 2 days of treatment. Below is a list of rare side effects of Shockwave Therapy.
· Hematoma (a bruise filled with blood)
· Petechiae (small purple spots on the skin from broken blood vessels)
· Skin lesions if you have had cortisone therapy before