Shockwave Therapy for Erectile Dysfunction

Recruiting at 2 trial locations

Overseen By Monica Johnson, RN

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Northwell Health

Must not be taking: Erectogenic medications

Disqualifiers: Penile implant, Pacemaker, Testicular cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Patients presenting with erectile dysfunction are often found to have increased corporal firmness on elastography. We hypothesize that this corporal firmness reflects reversable changes that can be altered by Low-Intensity Shockwave Therapy (LiST). In this pilot study patients found to have increased corporal firmness will be treated with LiST.

Eligibility Criteria

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

I am a man with erectile dysfunction and my tests show increased firmness.

Stated willingness to comply with all study procedures and availability for the duration of the study

Provision of signed and dated informed consent form

Exclusion Criteria

My ultrasound showed signs of testicular cancer.

My prostate cancer has not been treated.

Patients who are using devices which are sensitive to electromagnetic radiation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Low-Intensity Shockwave Therapy (LiST) to improve penile blood flow and restore sexual function

12 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Low-intensity acoustic shockwave therapy

Trial Overview The study tests whether Low-Intensity Shockwave Therapy (LiST) can alter the increased corporal firmness associated with erectile dysfunction. This pilot study will treat participants found to have this condition through standard evaluations.

Participant Groups

Group I: Low Intensity Acoustic Shockwave Therapy Experimental Treatment 1 Intervention

The device applies a low-intensity shockwave to the surface of the penis using an ultrasound gel as the coupling agent. The low-intensity shockwave therapy device will be used with the purpose of improving penile blood flow and restoring sexual function in men with impaired erectile function.

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+