Low-Intensity Shock Wave Therapy for Erectile Dysfunction

Overseen by Danielle Velez Leitner, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Rutgers, The State University of New Jersey

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this a clinical trial to investigate the effect of low-intensity shock wave therapy on patients with erectile function. The main questions it aims to answer are: 1. Can low-intensity shock wave therapy (LiSWT) to the penis improve male sexual health, particularly erectile function? 2. What is the optimal LiSWT protocol (number of shocks, energy delivered, timeline, etc) for initial and maintenance therapy? Researchers will compare validated questionnaires on erectile function in men treated with LiSWT compared to men who receive standard of care to see if there is an improvement in erectile function with LiSWT. Participants will be asked to complete questionnaires at each visit. Those who choose to undergo LiSWT will receive 6 sessions, once per week.

Research Team

Danielle Velez Leitner, MD

Principal Investigator

Rutgers Health

Eligibility Criteria

This trial is for men with erectile dysfunction. Participants will be asked to complete questionnaires and those opting for LiSWT will undergo six weekly sessions. Details on inclusion and exclusion criteria are not provided.

Inclusion Criteria

I am older than 18.

I can make my own decisions and sign consent forms.

I have had erectile dysfunction for at least 6 months.

Exclusion Criteria

I have a penile implant.

I use injections for erections.

Prisoners

Treatment Details

Interventions

• Low intensity shock wave (Shock Wave Therapy)

Trial Overview The study tests if low-intensity shock wave therapy (LiSWT) can improve erectile function in men compared to standard care, seeking the best treatment protocol through validated questionnaires.

Participant Groups

Group I: LiSWT Experimental Treatment 1 Intervention

men receiving LiSWT

Group II: Control Active Control 1 Intervention

Standard of care: phosphodiesterase 5 inhibitor therapy, vacuum erectile device, constriction bands, intracorporal injections, penile implant.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Dr. Jonathan Holloway

Rutgers, The State University of New Jersey

Chief Executive Officer since 2020

PhD in History from Yale University

Dr. Brian Strom

Rutgers, The State University of New Jersey

Chief Medical Officer since 2014

MD from Rutgers New Jersey Medical School