Shockwave Therapy for Erectile Dysfunction

(EXSTACY Trial)

Overseen By Karina Acevedo, Clinical Research Coordinator

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Penile prosthesis, Serious medical condition, Untreated severe psychological disease

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

Compensation: Varies

Number of Visits: 10

Duration: 6 weeks

157 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if shockwave therapy can help men with erectile dysfunction (ED), a condition where it's difficult to achieve or maintain an erection. The study uses light intensity shockwave therapy (LI-SWT) to identify who benefits most from this treatment. The goal is to discover factors that might predict a successful outcome. Men over 18 who have experienced difficulty with erections in at least half of their sexual encounters may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to understanding how this therapy can benefit others with ED.

What prior data suggests that this device is safe for treating Erectile Dysfunction?

Research has shown that shockwave therapy for erectile dysfunction (ED) is generally safe for patients. Studies have found that about 60% of patients consider it effective and safe, with benefits lasting up to 12 months. Other research supports this therapy as a promising short-term option for men with mild-to-moderate ED caused by blood flow issues to the penis.

Compared to some common ED medications, like Tadalafil, shockwave therapy appears safer. Overall, patients tolerate shockwave therapy well, and studies have not reported any major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for erectile dysfunction, which often involve medications like Viagra or Cialis, shockwave therapy stands out because it uses low-intensity sound waves to improve blood flow. This method could offer a non-invasive alternative without the need for daily pills or injections. Researchers are excited because shockwave therapy may not only provide a temporary fix but potentially improve the condition over time by rejuvenating blood vessels and tissues.

What evidence suggests that this device is effective for Erectile Dysfunction?

Research has shown that low-intensity shockwave therapy (LI-SWT), which participants in this trial will receive, can help men with erectile dysfunction (ED) improve their ability to achieve and maintain erections. Studies have found that men receiving LI-SWT often experience better results than those who do not. One study noted a significant increase in scores on a test measuring erectile health. Another study found that LI-SWT can enhance blood flow by promoting the growth of new blood vessels in the penis, which is crucial for erections. However, not all studies demonstrate strong effects, and results can vary among individuals. Overall, LI-SWT is considered safe with few side effects. ^{2 6 7 8 9}

Who Is on the Research Team?

Alan W. Shindel, MD, MAS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for men who have trouble getting or keeping an erection firm enough for sex (erectile dysfunction). Participants should be adults seeking treatment for ED. Specific inclusion and exclusion criteria are not listed, but generally those with ED interested in shockwave therapy may qualify.

Inclusion Criteria

I was born with a penis and have not had genital reconstruction.

I am over 18 years old.

Patient endorses the ability to comply with study procedures throughout the duration of the study

Exclusion Criteria

I have a penile implant (malleable or inflatable type).

Have a serious medical condition or illness that makes safety or compliance with study procedures and/or engagement in sexual activity inadvisable in the opinion of the PI

Untreated severe psychological disease such as psychosis or bipolar disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete questionnaires, blood tests, and EndoPAT assessment

1 day

1 visit (in-person)

Treatment

Participants receive 6 sessions of LI-SWT therapy administered to the penis and perineum

6 weeks

6 visits (in-person)

Follow-up

Participants complete questionnaires and are monitored for adverse reactions at 3, 6, and 12 months post-treatment

12 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Shockwave Therapy

Trial Overview

The study tests light intensity shockwave therapy (LI-SWT), a non-invasive device that delivers energy to the penis, to see how well it helps men with erectile dysfunction. All participants receive this therapy; there is no comparison group.

How Is the Trial Designed?

Group I: Shockwave therapy Experimental Treatment 1 Intervention

Once a week for 6 weeks

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

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

Effectiveness of Low-Intensity Extracorporeal Shock Wave ...

In all five included studies, it was observed that, within a timeframe of 1 to 12 months, the improvement in erectile function was greater in the Li-ESWT group ...

2.

tau.amegroups.org

tau.amegroups.org/article/view/130285/html

Is low-intensity shockwave therapy for erectile dysfunction a ...

Conclusions: Our analysis demonstrates sustained long-term improvement in erectile function after LiSWT for a heterogeneous cohort. While ...

3.

cda-amc.ca

cda-amc.ca/extracorporeal-shockwave-therapy-erectile-dysfunction

Extracorporeal Shockwave Therapy for Erectile Dysfunction

Data on the clinical effectiveness of different protocols of ESWT were limited. ESWT is safe, with few treatment-related adverse events.

4.

tandfonline.com

tandfonline.com/doi/full/10.1080/20565623.2025.2511438

Efficacy of low-intensity extracorporeal shock wave therapy ...

This meta-analysis of 12 RCTs, including 882 men with vasculogenic ED, demonstrated a statistically significant improvement in IIEF-EF score (an improvement ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04720755

Low Intensity Extracorporeal Shock Wave Therapy (Li- ...

The aim of this study is to assess for subjective and objective improvements in erectile function following treatment with Li-ESWT. Detailed Description.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5121537/

Twelve-Month Efficacy and Safety of Low-Intensity Shockwave ...

LISWT in patients with ED unresponsive to PDE5i treatment was effective and safe in 60% of patients treated. The efficacy response was maintained for 12 months ...

7.

renalandurologynews.com

renalandurologynews.com/news/shock-wave-therapy-prognostic-indicators-of-successful-ed-treatment/

Shock Wave Therapy Found Safe, Effective for Erectile ...

Low-intensity extracorporeal shock wave therapy (ESWT) can improve mild-to-moderate vasculogenic erectile dysfunction, a study found.

8.

tandfonline.com

tandfonline.com/doi/full/10.1080/2090598X.2022.2090134

Efficacy and safety of low-intensity extracorporeal shock ...

LIESWT has a comparable short-term therapeutic efficacy with higher safety outcomes than on-demand 20 mg of Tadalafil for ED patients.

9.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT02683044

NCT02683044 | Effectiveness And Safety Of Two Protocols ...

Determine the comparative effectiveness and safety of two treatment protocols for the use of low-intensity shock waves to treat patients with erectile ...