This study aims to compare two similar treatment protocols to deliver low-intensity shock wave therapy for erectile dysfunction. The main outcome to be investigated is the improvement in erectile function. The trial is recruiting in Miami (Florida), USA.
The details
Low-intensity shock wave therapy has recently been introduced as a new therapeutic approach for erectile dysfunction. Shock wave therapy allows for an increase in penile blood flow by delivering low-intensity (non-harmful) shock waves to the penis. These are believed to stimulate the formation of new blood vessels, which is important in achieving an erection.
This study will examine two similar treatment protocols to deliver low-intensity shock wave therapy. Changes in erectile function, sexual ability, and erection hardness will be measured using self-reported questionnaires.
Who are they looking for?
This study will recruit about 80 men aged between 30 and 80 years with mild or moderate erectile dysfunction. Participants should have erectile dysfunction for at least 6 months and not more than 5 years. Participants should have at least 2 sexual attempts per month for at least one month before taking part. Participants may or may not respond to PDE5 inhibitors (such as sildenafil [Viagra]), but should discontinue treatment 4 weeks before the study. Participants should have normal testosterone levels within 1 months of taking part.
Participants should not have undergone radiation to the pelvic region within the last 12 months or have a history of prostate surgery or extensive surgery in the pelvic region. Participants should not be recovering from cancer or have undergone hormone therapy in the past 12 months. Neurological conditions such as Alzheimers or Parkinsons disease that affect erectile function will prevent patients from taking part. Participants should not have a psychiatric condition, spinal cord injury, or an anatomical abnormality of the penis (such as Peyronie's Disease).
How will it work
Participants will be randomly assigned to undergo one of two LIST treatment protocols. The first protocol involves 5 daily sessions of LIST within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region. The second protocol involves 3 sessions of shockwave therapy per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region. Changes in erectile function, sexual ability, and erection hardness will be compared using self-reported questionnaires over a study period of 7 months.
