This trial is examining the effectiveness of low-intensity shockwave therapy (LIST) on patients with erectile dysfunction (ED). The main outcome will be the change in ED after 1 month of treatment. This study is being conducted in Virginia, US.
The details
ED (or impotence) affects 18 million men in the US. It consists of the inability to get and keep an erection firm enough for sex. Medications such as PDE5 inhibitors like sildenafil (viagra) are the recommended first-line therapies. However, their effectiveness can be limited to some patients.
Prior studies suggested that shockwave therapy is safe and well-tolerated in the treatment of ED. LIST is a non-invasive treatment that uses high-energy sound waves to speed up tissue repair. Many of the studies on LIST had limitations such as short durability and did not include men undergoing prostate cancer treatment (high prevalence of ED).
This trial is evaluating the effectiveness of LIST on men with different types of ED. The main objective of the study is a change in ED scores.
Who are they looking for?
This trial will be recruiting 338 participants with ED. These patients must male between the age of 30 and 80 and must stop PDE5 inhibitor medication for at least 2-4 weeks before starting this trial. Participants must have a testosterone level of over 300ng/dL and if diabetic must have a blood glucose control (HbA1c below 7.5%) within 3 months of the start of this trial. Patients with active surveillance for prostate cancer or who have received prostate surgery or radiation for prostate cancer more than a year before are accepted.
Participants must not have a history of extensive pelvic surgery, radiation therapy, or different cancer treatments within 12 months prior to the start of this trial. Must not have a brain injury that affects ED, history of spinal cord injury, or recovering from a different cancer type (other than prostate cancer).
How will it work
Participants will be divided into 3 different groups. The first group will consist of men with ED who received PDE5 inhibitor treatment. The second group will consist of those patients planning to undergo treatment for prostate cancer. The third group will be of those patients who have undergone treatment for prostatic cancer.
These patients will receive LIST or placebo (therapy with no effect on the body). The placebo treatment will be delivered as a 20-minute session twice weekly for 3 weeks. LIST will be delivered twice weekly for 3 weeks for 20 minutes, consisting of 3000 shockwaves delivered to the penis. Follow-up will occur at 1, 3, and 6 months following the end of the treatment.
The main outcomes to be measured will be the change in ED before and after treatment and side effects.
