Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Randomized Controlled Trial of Focused Shockwave, Radial Wave, and Sham Therapy for Erectile Dysfunction and Focused Shockwave and Sham Therapy for Chronic Pelvic Pain Syndrome in Patients With and Without History of Prostate Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 40 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether low-intensity shockwaves or radial waves help with erection problems or long-term pelvic pain. It compares these treatments with a sham (fake) treatment in adult men.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Erection problems group: Straight men age 18 or older who were born male and identify as male.
- Have a relationship lasting more than 3 months, a willing sexual partner, and a desire for sex with penetration.
- Have mild to moderate erection problems with a physical cause during the past 3 months, with an erection test score of 11–25.
- If erection pills called PDE5 inhibitors help fully or partly, agree to stop them 4 weeks before the trial and throughout the study.
- Agree to try intercourse at least 4 times a month during the study, without being under the influence of alcohol or recreational drugs.
- Have a morning testosterone level above 300 ng/dL. Testosterone is a sex hormone.
- Pelvic pain group: Men age 18 or older with long-term pelvic pain not explained by a urinary tract infection.
- Pelvic pain group: Be willing to do pelvic floor physical therapy, which works on muscles in the lower pelvis.
Who can't join
- Erection problems group: Erection problems caused by nerve injury or nerve disease, mainly caused by mental or emotional factors, or severe enough to score 10 or lower on the erection test.
- Untreated low testosterone (morning level below 300 ng/dL), or treatment to lower male hormones in the past 12 months.
- Penis scarring, bending, or another shape problem that affects penetration; past penis surgery deeper than the skin; past penis injury; erection injections in the past year; or a prior ultrasound showing that blood drains from the penis too quickly.
- Diabetes with an HbA1c blood sugar score of 8% or higher in the past year; poorly controlled cholesterol or blood pressure; serious heart disease; or a past heart attack.
- Smoking now or within the past year.
- A history of a mental health disorder, including bipolar disorder; current moderate or severe depression; current use of SSRI antidepressants or other mental health medicines; or a sudden prostate infection.
- Pelvic pain group: Pelvic pain caused by nerve injury or a nerve disease.
- Pelvic pain group: A sudden prostate infection, any other sudden infection in the pelvis, or a past pelvic injury.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Erectile Dysfunction Group (ED) Inclusion Criteria (ED): (all of the following) 1. Cis-gendered heterosexual adult males18 years old 2. Stable relationship of more than 3 months duration with currently willing sexual partner and desire for penetration. 3. Mild to moderate organic erectile dysfunction (IIEF-EF score 11-25) in the last 3 months 4. 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. 5. 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 6. Morning total testosterone level over 300ng/dL Exclusion Criteria (ED): 1. 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) 2. Untreated hypogonadism (morning total testosterone \<300 ng/dL) or on androgen deprivation therapy in the last 12 months 3. Predominately psychogenic ED based upon expert clinician opinion 4. Peyronie's disease, palpable plaque or curvature/penile anatomic abnormality that affects penetrative intercourse to any degree 5. History of non-superficial penile surgery (e.g, penile prosthesis, penectomy, plication, grafting) 6. History of penile injury or trauma (e.g, priapism, penile fracture) 7. Use of intracavernosal injection for ED within the last year 8. If diabetic, HbA1c 8% or higher within the past 12 months 9. Known corporal veno-occlusive dysfunction based on prior Doppler penile ultrasound 10. Current tobacco smoker, or has smoked in the past year 11. Poorly controlled hyperlipidemia 12. Poorly controlled hypertension 13. Severe cardiac disease or history of myocardial infarction 14. History of psychiatric disorder including bipolar disorder, current moderate or severe depression 15. Patients currently using SSRI or psychotropic medication 16. Severe ED based on IIEF-EF (score 10 or below) 17. Current acute prostatitis Chronic Pelvic Pain Syndrome Group: Inclusion Criteria (CPPS): (all of the following) 1. Adult males ≥18 years old 2. Chronic pelvic pain not explained by concurrent urinary tract infections. urine) 3. Willing to do PFPT Exclusion criteria (CPPS): 1. 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) 2. Acute prostatitis or any acute infection of the pelvic region 3. History of pelvic trauma
Study sites (1)
OH
- Cleveland Clinic Foundation · Cleveland, OH 44195Raevti Bole · Study contact · 216-445-8640 · BOLER@ccf.orgPetar Bajic, MD · Principal investigatorMore trials in Cleveland