Shockwave Therapy for Erectile Dysfunction

Recruiting in Palo Alto (17 mi)

Overseen by Petar Bajic, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The Cleveland Clinic

Must not be taking: SSRI, Psychotropic

Disqualifiers: Diabetes, Hypertension, Cardiac disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study to perform a randomized, sham controlled analysis of the effectiveness of both fSWT and rWT in the relief of erectile dysfunction and chronic pelvic pain syndrome.

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.

What data supports the effectiveness of shockwave therapy for erectile dysfunction?

Research shows that low-intensity extracorporeal shockwave therapy (Li-ESWT) is an emerging treatment for erectile dysfunction with good results reported in the literature. Studies have evaluated its effectiveness, including a single-blind, placebo-controlled, randomized clinical trial, indicating positive outcomes for patients with ED. ^{1 2 3 4 5}

Is shockwave therapy safe for humans?

Research on low-intensity extracorporeal shock wave therapy (Li-ESWT) for erectile dysfunction suggests it is generally safe for humans, with studies focusing on its safety alongside its effectiveness. ^{2 4 6 7 8}

How is shockwave therapy different from other treatments for erectile dysfunction?

Shockwave therapy for erectile dysfunction is unique because it uses sound waves to improve blood flow, unlike traditional treatments that often involve medication or surgery. This therapy can be administered using focused or radial waves, which differ in how deeply they penetrate tissue and the shape of the waves, offering a non-invasive option with varying effectiveness. ^{3 4 5 9 10}

Research Team

Petar Bajic, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Focused shockwave (Shockwave Therapy)
• Radial wave (Shockwave Therapy)
• Sham treatment (Procedure)

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.

Participant Groups

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 Canada for the following indications:

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+

David Peter

The Cleveland Clinic

Chief Medical Officer

MD, board-certified in Hospice and Palliative Medicine

Tomislav Mihaljevic

The Cleveland Clinic

Chief Executive Officer since 2018

MD from University of Zagreb School of Medicine

Findings from Research

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]

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) 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]

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) 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 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]

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]

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 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 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]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Low-intensity shock wave therapy for erectile dysfunction and the influence of disease duration. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Erectile Dysfunction Treatment Using Focused Linear Low-Intensity Extracorporeal Shockwaves: Single-Blind, Sham-Controlled, Randomized Clinical Trial. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The Basic Physics of Waves, Soundwaves, and Shockwaves for Erectile Dysfunction. [2021]

4. China pubmed.ncbi.nlm.nih.gov

Retrospective comparison of focused shockwave therapy and radial wave therapy for men with erectile dysfunction. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Low-intensity extracorporeal shockwave therapy for erectile dysfunction. [2022]

6. Brazil 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. [2022]

7. Korea (South) 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. [2020]

8. China 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. [2022]

9. China pubmed.ncbi.nlm.nih.gov

Low-intensity extracorporeal shockwave therapy for erectile dysfunction: an overview of systematic reviews. [2022]

10. United States 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. [2022]