ClinicalTrials.gov record NCT05868668
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
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This randomized, double-blind study compares two types of low-intensity shockwave therapy with a sham procedure in men with erectile dysfunction or chronic pelvic pain. Men with erectile dysfunction are randomized 2:2:1 to focused shockwave, radial wave, or sham. Men with chronic pelvic pain are randomized 1:1 to focused shockwave plus pelvic-floor physical therapy or pelvic-floor therapy plus sham. Outcomes are assessed at baseline, 3 months, and 6 months.
What it is studying. The study tests whether shockwave therapy produces different changes in symptom scores than a sham treatment. For erectile dysfunction it compares focused shockwave therapy (fSWT) and radial wave therapy (rWT) with sham; for chronic prostatitis/chronic pelvic pain it compares fSWT plus pelvic-floor therapy with pelvic-floor therapy plus sham. Main measures are change in the International Index of Erectile Function (IIEF) for ED and change in the Chronic Prostatitis Symptom Index (CPSI) for pelvic pain.
What the researchers hope to learn. To evaluate changes and minimum clinically important differences in IIEF scores for erectile dysfunction and CPSI scores for chronic prostatitis/chronic pelvic pain. Secondary goals include measuring Sexual Encounter Profile (SEP) responses, Global Assessment Questionnaire (GAQ) responses, and Erection Hardness Score (EHS).
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Device
- Focused shockwave
- Radial wave
- Sham treatment
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Erectile Dysfunction Group (ED) 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
- (ED):
- 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
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
After being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. Participants who meet eligibility requirements will be randomized in a double blind manner (participant and investigator) to each treatment arm depending on their primary complaint. Participants with erectile dysfunction will be randomized 2:2:1 to either fSWT, rWT or sham therapy. Patients with chronic pelvic pain syndrome will be randomized 1:1 to either fSWT with pelvic floor physical therapy (PFPT) or PFPT with sham treatment.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
After consent and screening (including symptom questionnaires and a morning testosterone check for ED), participants are randomized in a double-blind way to device treatments or sham depending on their complaint. ED participants are randomized 2:2:1 to focused shockwave, radial wave, or sham; CPPS participants are randomized 1:1 to focused shockwave plus pelvic-floor physical therapy (PFPT) or PFPT with sham. Participation involves non-invasive device treatment sessions, PFPT for CPPS arms, and follow-up symptom questionnaires at baseline, 3 months, and 6 months. ED participants who currently use a PDE5 inhibitor and respond, or partly respond, to it must be willing to stop it for 4 weeks before the trial and remain off it during the study. ED participants also follow the study requirement to attempt intercourse at least four times per month while enrolled.
How the study is structured. Interventional, randomized, parallel-group device trial with double blinding of participants and investigators. ED participants are randomized 2:2:1 to fSWT, rWT, or sham. Chronic pelvic pain participants are randomized 1:1 to fSWT plus pelvic-floor physical therapy (PFPT) or PFPT plus sham. Participants are assessed at baseline, 3 months, and 6 months.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Erectile Dysfunction Due to Arterial Insufficiency; Erectile Dysfunction; Erectile Dysfunction Due to Arterial Disease; Chronic Pelvic Pain Syndrome; Chronic Prostatitis; Erectile Dysfunction Following Radical Prostatectomy; Erectile Dysfunction Following Radiation Therapy. Does it apply to my diagnosis?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
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Important dates
- Study start
- Sep 19, 2023
- Primary completion
- December 2026 (estimated)
- Study completion
- June 2027 (estimated)
- Target enrollment
- 186 participants (estimated)
- Last updated on registry
- Aug 19, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- The Cleveland Clinic
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Petar Bajic 📞 216-444-1231 ✉ bajicp@ccf.org
Participating sites (1)
- Cleveland Clinic FoundationRecruiting
Cleveland, Ohio, 44195 · United States
- Raevti Bole · 216-445-8640 · BOLER@ccf.org
- Petar Bajic, MD
Terms used on this page · explanations by MedicalUpdates.ai
- randomized
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
- sham
- A procedure designed to resemble the real procedure, for example the same visit and equipment, without its active part. It is the procedure equivalent of a placebo.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- double blind
- Two types of people involved in the study do not know which intervention a participant is receiving. The ClinicalTrials.gov record specifies who is masked, for example participants, care providers, investigators or outcome assessors.
- treatment arm
- One of the groups in a study. Each arm receives a particular intervention, comparator or no intervention, so the groups can be compared.
- 2:1
- How many participants go to each group. In a 2:1 ratio, two are assigned to the first group for every one assigned to the second.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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