NCT05868668 · The Cleveland Clinic
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
(Shockwave)
What this study is about
The purpose of this study to perform a randomly assigned, sham controlled analysis of the effectiveness of both fSWT and rWT in the relief of erectile dysfunction and chronic pelvic pain syndrome.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- (ED): (all of the following)
- Cis-gendered heterosexual adult males18 years old
- Stable relationship of more than 3 months duration with currently willing sexual partner and desire for penetration.
- Mild to moderate organic erectile dysfunction (IIEF-EF score 11-25) in the last 3 months
- If ED responsive or partially responsive to current use of PDE5I, participant must be willing to discontinue PDE5I for 4 weeks prior to trial and remain off PDE5I for the duration of the study. Partially responsive ED is defined as inadequate response for desired sexual activity, or poorly maintained erection despite initially good response.
- Agreeable to attempt sexual intercourse at least 4 times per month for duration of study without being under the influence of alcohol or recreational drugs
- Morning total testosterone level over 300ng/dL
Exclusion criteria
- Nerve-injury related ED (/spinal cord injury, severe lumbosacral disorder (radiculopathy, spinal stenosis) or other neurological disease affecting erectile functions (e.g, multiple sclerosis, alzheimer's disease, parkinsons disease, amyotrophic lateral sclerosis)
- Untreated hypogonadism (morning total testosterone \<300 ng/dL) or on androgen deprivation therapy in the last 12 months
- Predominately psychogenic ED based upon expert clinician opinion
- Peyronie's disease, palpable plaque or curvature/penile anatomic abnormality that affects penetrative intercourse to any degree
- History of non-superficial penile surgery (e.g, penile prosthesis, penectomy, plication, grafting)
- History of penile injury or trauma (e.g, priapism, penile fracture)
- Use of intracavernosal injection for ED within the last year
- If diabetic, HbA1c 8% or higher within the past 12 months
- Known corporal veno-occlusive dysfunction based on prior Doppler penile ultrasound
- Current tobacco smoker, or has smoked in the past year
- Poorly controlled hyperlipidemia
- Poorly controlled hypertension
- Severe cardiac disease or history of myocardial infarction
- History of psychiatric disorder including bipolar disorder, current moderate or severe depression
- Patients currently using SSRI or psychotropic medication
- Severe ED based on IIEF-EF (score 10 or below)
- Current acute prostatitis Chronic Pelvic Pain Syndrome Group: Inclusion Criteria (CPPS): (all of the following)
- Adult males ≥18 years old
- Chronic pelvic pain not explained by concurrent urinary tract infections. urine)
- Willing to do PFPT Exclusion criteria (CPPS):
- Nerve-injury related pelvic pain (history of /spinal cord injury, severe lumbosacral disorder (radiculopathy, spinal stenosis) or other neurological disease affecting pain in the pelvic region(Multiple sclerosis, Alzheimer's, Parkinsons disease)
- Acute prostatitis or any acute infection of the pelvic region
- History of pelvic trauma
Where
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 21, 2026 · Source of record for eligibility and locations