Actively Recruiting
Randomized Controlled Trial of Focused Shockwave, Radial Wave, and Sham Therapy for Erectile Dysfunction and Chronic Pelvic Pain Syndrome in Patients With and Without History of Prostate Cancer
Led by The Cleveland Clinic · Updated on 2026-01-21
186
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of focused shockwave therapy (fSWT) and radial wave therapy (rWT) in relieving erectile dysfunction and chronic pelvic pain syndrome. This randomized, double-blind study includes participants with erectile dysfunction or chronic pelvic pain, aiming to compare these treatments against sham therapy to better understand their impact. The trial also considers patients with and without a history of prostate cancer. Participants with erectile dysfunction are randomly assigned in a 2:2:1 ratio to receive either focused shockwave therapy, radial wave therapy, or sham treatment. Those with chronic pelvic pain syndrome are randomized 1:1 to receive focused shockwave therapy combined with pelvic floor physical therapy or pelvic floor physical therapy with sham treatment. Treatments involve specific devices designed to deliver shockwave or radial wave therapy. During the study, participants will be assessed at baseline, 3 months, and 6 months for changes in erectile dysfunction or chronic pelvic pain symptoms. Assessments include clinical evaluations and questionnaires to monitor symptom relief and treatment effects. Participants are monitored closely throughout the trial, with adherence to therapy and safety evaluated by the research team. The total duration of participation varies depending on the timeline of assessments and treatment phases.
CONDITIONS
Brief 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 duration 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 inhibitors for 4 weeks before the trial and remain off during the study if previously responsive or partially responsive
- Agreeable to attempt sexual intercourse at least 4 times per month during the study without influence of alcohol or recreational drugs
- Morning total testosterone level over 300 ng/dL
- Adult males aged 18 years or older with chronic pelvic pain not explained 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, ALS)
- Untreated hypogonadism or androgen deprivation therapy in the last 12 months
- Predominantly psychogenic erectile dysfunction
- Peyronie's disease or penile anatomical abnormalities affecting intercourse
- History of non-superficial penile surgery or penile injury
- Use of intracavernosal injection for erectile dysfunction within the last year
- Diabetic patients with HbA1c 8% or higher within the past 12 months
- Known corporal veno-occlusive dysfunction
- Current or recent tobacco smoking within the past year
- Poorly controlled hyperlipidemia or hypertension
- Severe cardiac disease or history of myocardial infarction
- History of psychiatric disorders including bipolar disorder or current moderate/severe depression
- Current use of SSRI or psychotropic medications
- Severe erectile dysfunction (IIEF-EF score 10 or below)
- Current acute prostatitis or any acute infection of the pelvic region
- History of pelvic trauma
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Duration as per treatment protocol (not specified)
Participants receive assigned treatments including focused shockwave, radial wave, or sham therapy for erectile dysfunction and pelvic pain.
Multiple treatment visits as scheduled per treatment arm
Duration - Up to 6 months
Participants are followed up to assess outcomes related to erectile dysfunction and chronic pelvic pain at 3 and 6 months after baseline.
Visits at 3 and 6 months post-treatment
Trial Site Locations
Total: 1 location
1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
P
Petar Bajic
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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