Actively Recruiting
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Led by The Cleveland Clinic · Updated on 2026-01-21
186
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cis-gendered heterosexual adult males 18 years or older
- Stable relationship of more than 3 months with a willing sexual partner and desire for penetration
- Mild to moderate organic erectile dysfunction (IIEF-EF score 11-25) in the last 3 months
- Willing to discontinue PDE5 inhibitor use for 4 weeks prior to and during the study if previously responsive or partially responsive
- Agreeable to attempt sexual intercourse at least 4 times per month without alcohol or recreational drug use during the study
- Morning total testosterone level over 300 ng/dL
- Adult males 18 years or older with chronic pelvic pain not caused by urinary tract infections
- Willing to participate in pelvic floor physical therapy
You will not qualify if you...
- Nerve-injury related erectile dysfunction or pelvic pain (e.g., spinal cord injury, severe lumbosacral disorder, neurological diseases such as multiple sclerosis, Alzheimer's, Parkinson's, or ALS)
- Untreated low testosterone or recent androgen deprivation therapy
- Predominantly psychogenic erectile dysfunction
- Penile abnormalities affecting intercourse (e.g., Peyronie's disease, plaques, curvature)
- History of non-superficial penile surgery or penile trauma
- Use of intracavernosal injection for erectile dysfunction within the last year
- Diabetes with HbA1c 8% or higher within the past year
- Known corporal veno-occlusive dysfunction
- Current tobacco use or smoking within the past year
- Poorly controlled high cholesterol or high blood pressure
- Severe heart disease or history of heart attack
- Psychiatric disorders including bipolar disorder or moderate to severe depression
- Current use of SSRIs or psychotropic medications
- Severe erectile dysfunction (IIEF-EF score 10 or below)
- Current acute prostatitis or any acute pelvic infection
- History of pelvic trauma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
P
Petar Bajic
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here