Shockwave Therapy for Erectile Dysfunction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests low-intensity acoustic shockwave therapy to determine its effectiveness in improving erectile dysfunction by enhancing blood flow and sexual function. The focus is on men with increased firmness in the penis, which might be reversible with this treatment. Sexually active men diagnosed with erectile dysfunction may be suitable candidates for this study. As an unphased trial, participants can contribute to innovative research that could lead to new treatment options.
Will I have to stop taking my current medications?
If you are using medications for erectile dysfunction, like PDE5 inhibitors or penile injection therapy, you need to stop them at least two weeks before the first visit. Other medications are not mentioned, so it's best to discuss with the study team.
What prior data suggests that this device is safe for treating erectile dysfunction?
Research has shown that low-intensity shockwave therapy (LiST) for erectile dysfunction is generally easy for patients to handle. Most studies find that patients do not experience serious side effects. Some individuals might feel slight discomfort or tingling during the treatment, but these sensations are usually mild and resolve quickly.
A review of clinical studies reported no serious problems, suggesting that the therapy is safe for most people. This treatment is gaining popularity in the U.S. and is available from many healthcare providers, further supporting its safety.
Although the FDA has not specifically approved the therapy for erectile dysfunction, the lack of serious side effects in the reviewed studies suggests it is a safe option for those considering this treatment.12345Why are researchers excited about this trial?
Unlike the standard treatments for erectile dysfunction, such as oral medications like Viagra or Cialis, low-intensity acoustic shockwave therapy offers a non-invasive approach that directly targets the problem. This therapy uses sound waves to improve blood flow to the penis, potentially restoring natural erectile function without the need for pills or injections. Researchers are excited because it represents a novel method that could provide long-term benefits and address the root cause of erectile dysfunction rather than just its symptoms.
What evidence suggests that this shockwave therapy is effective for erectile dysfunction?
Research has shown that low-intensity sound wave therapy, which participants in this trial will receive, can help men with erectile dysfunction (ED) by improving blood flow to the penis, potentially restoring sexual function. A review of several studies found that men who received this treatment reported better erectile function, regardless of the severity of their ED. More people in the U.S. are trying this therapy, although some remain unsure about it. Overall, current evidence suggests it could be a promising option for those with ED.14678
Are You a Good Fit for This Trial?
This trial is for sexually active men aged 18-64 with erectile dysfunction who have shown increased penile firmness on elastography. Participants must consent to the study's procedures and be available throughout its duration. Men using erectogenic medications, those with penile implants, cardiac devices, or sensitive to electromagnetic radiation are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Low-Intensity Shockwave Therapy (LiST) to improve penile blood flow and restore sexual function
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Low-intensity acoustic shockwave therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwell Health
Lead Sponsor