Low-Intensity Shock Wave Therapy for Erectile Dysfunction

Overseen By Danielle Velez Leitner, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Penile injections, Penile implant, others

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

Compensation: Varies

Number of Visits: 13

Duration: 6 weeks

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive low-intensity shock wave therapy (LiSWT) once per week for 6 weeks

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment using validated questionnaires

12 months

4 visits (in-person or virtual) at 1, 3, 6, and 12 months

Long-term follow-up

Participants continue to be monitored for long-term effects and efficacy of the treatment

24 months

2 visits (in-person or virtual) at 18 and 24 months

Treatment Details

Interventions

• Low intensity shock wave

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+