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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 and 6 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have chronic pelvic pain and no signs of a urinary infection.
Select...
I am a man over 40 years old and identify as heterosexual.
Select...
My erectile dysfunction responds somewhat to medication, but not fully.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Secondary outcome measures
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
1,029 Previous Clinical Trials
1,365,023 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still availability for volunteers to participate in this experiment?

"Affirmative. Clinicaltrials.gov indicates that this medical investigation is currently scouting for participants; the trial was first posted on June 1st 2023 and most recently updated on May 11th of the same year. The study requires 55 patients to be recruited from a single location."

Answered by AI

How many participants are included in the enrollment of this research?

"Affirmative. According to clinicaltrials.gov, this research endeavor is presently recruiting participants; it was first posted on June 1st 2023 and the last edit occurred on May 11th 2023. This study seeks 55 volunteers at a singular site."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
What site did they apply to?
Cleveland Clinic Foundation
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Want to help improve erectile dysfunction.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
2023. "Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05868668.
All > Prostatitis > Erectile Dysfunction
~36 spots leftby Jun 2025
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