Shockwave Therapy for Erectile Dysfunction

(Shockwave Trial)

Overseen By Petar Bajic

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Must not be taking: SSRI, Psychotropic

Disqualifiers: Diabetes, Hypertension, Cardiac disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

186 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of shockwave therapy to determine their effectiveness for erectile dysfunction and chronic pelvic pain. One group will receive focused shockwave treatment, another will receive radial wave treatment, and a third group will receive a sham (fake) treatment for comparison. Men with mild to moderate erectile dysfunction for at least three months or those with long-term pelvic pain may be suitable candidates. Participants should be prepared to discontinue current erectile dysfunction medications for the study's duration and should not have severe health issues, such as uncontrolled diabetes or recent heart problems. As an unphased trial, this study provides a unique opportunity to explore innovative treatments that could enhance quality of life.

Will I have to stop taking my current medications?

If you are using PDE5 inhibitors (medications for erectile dysfunction), you will need to stop taking them 4 weeks before the trial and remain off them during the study. The protocol does not specify about other medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both focused shockwave therapy (fSWT) and radial wave therapy (rWT) are generally safe for treating erectile dysfunction. Studies have found that low-intensity extracorporeal shock wave therapy, similar to fSWT, is safe and well-tolerated by patients. Few reports of serious side effects make it a promising option for erectile dysfunction.

Similarly, research on radial wave therapy (rWT) suggests it is safe. Reports indicate no major safety concerns with rWT, although it might not be as effective as some other treatments. Most patients handle the therapy well, with few negative effects.

Overall, both treatments appear safe based on current studies. However, while safety looks promising, more research may be needed to fully understand the potential side effects and effectiveness of these therapies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about shockwave therapy for erectile dysfunction because it offers a novel, non-invasive approach that could improve blood flow to the penis, potentially addressing the root cause of the condition. Unlike traditional treatments like oral medications (such as Viagra) that temporarily enhance blood flow, focused shockwave therapy (fSWT) and radial wave therapy (rWT) aim to stimulate the growth of new blood vessels, leading to more lasting improvements. This regenerative potential sets it apart from other treatments, offering hope for patients seeking longer-term solutions without the need for daily medication.

What evidence suggests that this trial's treatments could be effective for erectile dysfunction?

This trial will compare different treatments for erectile dysfunction. Research has shown that focused shockwave therapy (fSWT), one of the treatments in this trial, can improve erectile dysfunction (ED). Studies have found that fSWT helps men achieve and maintain firmer erections by using gentle shockwaves to boost blood flow to the penis. This treatment has proven effective for many men with ED.

Radial wave therapy (rWT) is another treatment option in this trial. Results for rWT are mixed; some studies suggest it can help with ED, but fSWT usually provides better results. In some cases, rWT showed little improvement, especially for men with mild to moderate ED. ^{5 6 7 8 9}

Who Is on the Research Team?

Petar Bajic, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for cis-gendered heterosexual adult males aged 40 or older with mild to moderate organic erectile dysfunction and a stable relationship. They must have a morning testosterone level over 300ng/dL, be willing to try sexual intercourse at least four times per month without alcohol/drugs, and not use certain ED medications during the study.

Inclusion Criteria

I am willing to undergo PFPT.

I agree to try having sex 4 times a month without alcohol or drugs during the study.

Your testosterone level is higher than 300ng/dL in the morning.

Exclusion Criteria

I currently have an infection in my pelvic area.

I have had an injury to my pelvic area before.

My blood pressure is often higher than 130/80 mmHg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either focused shockwave therapy, radial wave therapy, or sham treatment based on randomization

6 months

Regular visits as per treatment protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Focused shockwave
• Radial wave
• Sham treatment

Trial Overview The trial is testing the effectiveness of low-intensity shockwave therapy (fSWT) versus radial wave therapy (rWT) against a sham treatment in relieving symptoms of erectile dysfunction and chronic pelvic pain syndrome. Participants will be randomly assigned to one of these treatments.

How Is the Trial Designed?

Group I: fSWT Experimental Treatment 1 Intervention

Focused Shock wave treatments

Group II: rWT Active Control 1 Intervention

Radial wave treatments

Group III: Sham Placebo Group 1 Intervention

Sham treatments

Focused shockwave is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Li-ESWT for:

• Erectile dysfunction
• Chronic pelvic pain syndrome

Approved in United States as Li-SWT for:

• Erectile dysfunction
• Peyronie's disease
• Male pelvic pain

Approved in Canada as fSWT for:

• Erectile dysfunction
• Chronic pelvic pain syndrome

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

Low-intensity extracorporeal shockwave therapy (Li-ESWT) is a promising treatment for erectile dysfunction (ED), but it is currently investigational and not FDA-approved in the U.S., highlighting the need for further clinical trials.

Understanding the physics of shockwaves, including the differences between various shockwave generators (electrohydraulic, electromagnetic, and piezoelectric), is crucial for physicians to effectively evaluate and utilize Li-ESWT devices in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Basic Physics of Waves, Soundwaves, and Shockwaves for Erectile Dysfunction. Katz, JE., Clavijo, RI., Rizk, P., et al.[2021]

In a study involving 96 patients with erectile dysfunction, low-intensity extracorporeal shock wave therapy (Li-ESWT) significantly improved erectile function scores compared to a sham treatment, with a median change in the IIEF-EF score of 5.1 versus -2.2 after 7 weeks (p<0.001).

Li-ESWT was found to be safe, with no reported pain or adverse events during treatment, making it a promising new option for patients with erectile dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electromagnetic Low-Intensity Extracorporeal Shock Wave Therapy in Patients with Erectile Dysfunction: A Sham-Controlled, Double-Blind, Randomized Prospective Study. Kim, KS., Jeong, HC., Choi, SW., et al.[2020]

Both focused shockwave therapy (fSWT) and radial wave therapy (rWT) were found to be moderately effective treatments for erectile dysfunction (ED), with significant improvements in Sexual Health Inventory in Men (SHIM) scores after treatment.

There was no significant difference in efficacy between fSWT and rWT, as both treatments resulted in similar improvements in SHIM scores, and no side effects were reported for either therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective comparison of focused shockwave therapy and radial wave therapy for men with erectile dysfunction. Wu, SS., Ericson, KJ., Shoskes, DA.[2022]

Low-intensity extracorporeal shockwave therapy (LI-ESWT) shows potential as a complementary treatment for erectile dysfunction (ED), with evidence suggesting benefits for patients, although the overall confidence in the studies is critically low due to methodological flaws.

The therapy appears to have no significant side effects, but the effectiveness may vary based on the number of treatments and energy levels used, highlighting the need for more rigorous studies to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-intensity extracorporeal shockwave therapy for erectile dysfunction: an overview of systematic reviews. Yuan, F., Wang, Y., Ma, Z., et al.[2022]

Low-intensity extracorporeal shock wave therapy (LI-ESWT) significantly improves erectile function in patients with erectile dysfunction (ED), showing an 8.31 times higher effective treatment rate compared to sham treatment based on the Erectile Hardness Score (EHS).

The therapy appears safe, with no significant adverse events reported, and a nine-week treatment protocol with specific energy settings showed better results than a shorter five-week protocol, indicating its potential as a noninvasive option for ED management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term efficacy and safety of low-intensity extracorporeal shock wave therapy in erectile dysfunction: a systematic review and meta-analysis. Zou, ZJ., Tang, LY., Liu, ZH., et al.[2022]

Low-intensity extracorporeal shock wave therapy (Li-ESWT) demonstrated similar efficacy to sildenafil in treating erectile dysfunction, with no significant difference in International Index of Erectile Function-5 (IIEF-5) scores between the two treatments after three months.

Both Li-ESWT and sildenafil were found to have comparable safety profiles, with only mild and transient adverse events reported in both treatment groups, indicating that Li-ESWT could be a viable alternative to medication for erectile dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy and safety of low-intensity extracorporeal shock wave therapy versus on-demand sildenafil for erectile dysfunction. Lei, Q., Wang, D., Liu, C., et al.[2022]

Low-intensity shockwave therapy (Li-SWT) is an effective and safe treatment for erectile dysfunction (ED), showing significant improvements in Sexual Health Inventory in Men (SHIM), International Index of Erectile Function (IIEF-5), and Erection Hardness Score (EHS) after 8 weeks of treatment with no reported side effects.

The study, which included 94 men, found that the efficacy of Li-SWT was consistent across different shockwave technologies and treatment protocols, indicating that the type of device used does not significantly impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shockwave Therapy for Erectile Dysfunction: Which Gives the Best Results? A Retrospective National, Multi-Institutional Comparative Study of Different Shockwave Technologies. Ghahhari, J., De Nunzio, C., Lombardo, R., et al.[2022]

In a randomized clinical trial involving 60 patients, low-intensity extracorporeal shock wave therapy (Li-ESWT) significantly improved erectile function, as measured by various scales, at both 4 and 12 weeks post-treatment.

Patients reported increased satisfaction with their erections and overall sexual experience, with statistically significant improvements in scores for erection quality and partner satisfaction, indicating Li-ESWT is an effective treatment for erectile dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erectile Dysfunction Treatment Using Focused Linear Low-Intensity Extracorporeal Shockwaves: Single-Blind, Sham-Controlled, Randomized Clinical Trial. Sramkova, T., Motil, I., Jarkovsky, J., et al.[2021]

Low-intensity extracorporeal shockwave therapy (LI-ESWT) showed a statistically significant improvement in erectile function for 348 out of 920 male patients in a review of 11 randomized clinical trials, indicating some efficacy in treating erectile dysfunction (ED).

Despite these positive results, 572 patients did not experience significant improvement, highlighting that the effectiveness of LI-ESWT for ED remains controversial and necessitates further high-quality studies to clarify its potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-intensity extracorporeal shockwave therapy for erectile dysfunction. Canguven, O., Khalafalla, K., Al Ansari, A.[2022]

Low-intensity shock-wave treatment (LiSWT) significantly improved erectile function in patients with erectile dysfunction (ED), as shown by an increase in the IIEF-5 scores from a median of 14 at baseline to 18 at three months post-treatment.

The duration of ED (whether ≤ 24 months or > 24 months) did not negatively affect the treatment outcomes, indicating that LiSWT is effective regardless of how long a patient has experienced ED.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-intensity shock wave therapy for erectile dysfunction and the influence of disease duration. De Oliveira, PS., De Oliveira, TR., Nunes, Á., et al.[2019]

Citations

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Efficacy of low-intensity extracorporeal shock wave therapy ... Li-ESWT involves using gentle shockwaves to treat erectile dysfunction (ED) which is when a man has difficulty getting or maintaining a firm erection for ...

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The recommended treatment protocol for low-intensity ... The recommended treatment protocol for low-intensity shockwave therapy based on the severity of erectile dysfunction

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

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Low-Intensity Shockwave Therapy for Erectile Dysfunction ... Low-intensity shockwave therapy (LiST) has been shown to be an efficacious and safe treatment for erectile dysfunction (ED).1, 2, 3, 4 Published clinical ...

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A Prospective Randomized Study on Low-Energy ... These results indicated that low-intensity extracorporeal shock wave therapy for erectile dysfunction in men who had undergone radical ...

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