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Shockwave Therapy

Shockwave Therapy for Erectile Dysfunction

N/A
Recruiting
Led By Petar Bajic, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronic pelvic pain with no obvious signs of infection in urine (<10 WBC per HPF in mid-stream urine)
Cis-gendered heterosexual adult males ≥40 years old
Must not have
Acute prostatitis or any acute infection of the pelvic region
History of pelvic trauma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 and 6 months

Summary

This trial studies the effectiveness of two treatments for erectile dysfunction and pelvic pain: focused shockwave therapy and radial shockwave therapy.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort or bruising at the site of treatment, skin irritation, temporary increase in pain or numbness, and possible worsening of erectile function if the treatment does not work as intended.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have chronic pelvic pain and no signs of a urinary infection.
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I am a man over 40 years old and identify as heterosexual.
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My erectile dysfunction responds somewhat to medication, but not fully.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have an infection in my pelvic area.
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I have had an injury to my pelvic area before.
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My blood pressure is often higher than 130/80 mmHg.
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I have a spinal or neurological condition affecting my sexual function.
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I have low testosterone levels or have been on hormone therapy in the past year.
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I have Peyronie's disease or a penile condition that affects sex.
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I have had a penile injury or trauma.
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I have had surgery on my penis that was not a circumcision.
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I have used injections for erectile dysfunction in the past year.
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My cholesterol levels are high and hard to manage.
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I have a psychiatric condition or am taking medication for mental health.
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My latest HbA1c level was 7.5 or higher.
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I have severe heart disease or had a heart attack before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Secondary study objectives
Erectile Dysfunction

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: fSWTExperimental Treatment1 Intervention
Focused Shock wave treatments
Group II: rWTActive Control1 Intervention
Radial wave treatments
Group III: ShamPlacebo Group1 Intervention
Sham treatments

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,052 Previous Clinical Trials
1,370,978 Total Patients Enrolled
1 Trials studying Erectile Dysfunction
34 Patients Enrolled for Erectile Dysfunction
Petar Bajic, MDPrincipal InvestigatorThe Cleveland Clinic

Media Library

Erectile Dysfunction Patient Testimony for trial: Trial Name: NCT05868668 — N/A
~41 spots leftby Jun 2025
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