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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether low-intensity shock wave therapy (LiSWT) can improve erectile function in men. Researchers aim to determine if this therapy can enhance male sexual health and identify the best treatment plan. Participants will be compared to those receiving standard treatments, such as medications or devices. Men who have experienced erectile dysfunction for at least six months may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in male sexual health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anticoagulant or anti-platelet therapy (medications that prevent blood clots).

What prior data suggests that this therapy is safe for erectile dysfunction?

A previous study found low-intensity shock wave therapy (LiSWT) to be a safe treatment for erectile dysfunction. Research shows that most patients tolerate it well, with few reports of serious side effects. Some patients might experience minor discomfort or notice bruising in the treated area, but these usually resolve on their own.

Experts indicate that more long-term studies are needed to fully understand its safety over time. This treatment is already used for some other conditions, suggesting it is quite safe. However, like any treatment, it is important to consider the potential benefits and risks. Always consult a healthcare provider when considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Low-Intensity Shock Wave Therapy (LiSWT) is unique because it offers a non-invasive approach to treating erectile dysfunction (ED) by using acoustic waves to improve blood flow. Unlike standard treatments like pills, pumps, or injections that provide temporary symptom relief, LiSWT aims to address the root cause by promoting the natural repair of blood vessels. Researchers are excited about this therapy because it has the potential to provide longer-lasting improvements in erectile function without the need for ongoing medication or devices.

What evidence suggests that low-intensity shock wave therapy is effective for erectile dysfunction?

This trial will compare low-intensity shock wave therapy (LiSWT) with standard treatments for erectile dysfunction (ED). Studies have shown that LiSWT can improve erectile function in men with ED. Research suggests that LiSWT may help by boosting blood flow to the penis, which is crucial for achieving and maintaining an erection. In some studies, men reported better erections after receiving LiSWT compared to those who did not receive the treatment. This therapy is considered promising, with results indicating improvements regardless of ED severity. However, researchers are still determining the optimal use of this treatment, including the number of sessions needed and the strength of the waves, to ensure lasting effects. ^{2 6 7 8 9}

Who Is on the Research Team?

Danielle Velez Leitner, MD

Principal Investigator

Rutgers Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11535733/

Is low-intensity shockwave therapy for erectile dysfunction ... Erectile dysfunction (ED) is an increasingly prevalent disorder with increased age and presence of comorbid conditions (1). As the predominant ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04434352

Low Intensity Shockwave Therapy for Erectile Dysfunction Is low-intensity shockwave therapy for erectile dysfunction a durable treatment option?-long-term outcomes of a randomized sham-controlled trial. Transl ...

3. afju.springeropen.com afju.springeropen.com/articles/10.1186/s12301-025-00489-8

The efficacy of low-intensity shock wave therapy based on the ... Vardi et al. pioneered the application of LI-ESWT as therapy for erectile dysfunction (ED) [1]. LI-ESWT therapy is a novel therapeutic approach ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10890328/

Effectiveness of Low-Intensity Extracorporeal Shock Wave ... Thus, subjective results suggest that shock waves could enhance erectile function in patients with ED, regardless of the severity of the dysfunction. Penile ...

5. nature.com nature.com/articles/s41443-024-00959-7

The recommended treatment protocol for low-intensity ... Low-intensity shockwave therapy for erectile dysfunction: a randomized clinical trial comparing 2 treatment protocols and the impact of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4756974/

Safety and efficacy of low intensity shockwave (LISW ... LISW is a confirmed therapeutic approach to erectile dysfunction that definitely needs more long-term trials to be clarified and further verified.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03067987

Safety and Efficacy of Low Intensity Shockwave for the ... Renova-Erectile dysfunction (ED) is a Linear Shockwaves (LISW) device which incorporates a unique shockwave transducer operable to deliver shockwaves to a ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1743609519312123

Is It Safe for Patients on Anticoagulant Medication? Low-intensity shock wave therapy for the treatment of vasculogenic erectile dysfunction: A narrative review of technical considerations and treatment outcomes.

9. academic.oup.com academic.oup.com/jsm/advance-article/doi/10.1093/jsxmed/qdaf305/8307682

Early low-intensity extracorporeal shockwave therapy for the ... low-intensity shockwave therapy, safety data, erectile function, postprostatectomy ... Yet, despite these technical strides, erectile dysfunction ...