Erectile Dysfunction Due to Arterial InsufficiencyShockwaveNCT05868668
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
A study testing Focused shockwave and Radial wave in people with Erectile Dysfunction Due to Arterial Insufficiency and Erectile Dysfunction, run by The Cleveland Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction, Erectile Dysfunction Due to Arterial Disease
- What is being tested?
- Focused shockwave and Radial wave
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males ≥18 years old
- Chronic pelvic pain not explained by concurrent urinary tract infections. urine)
- Willing to do PFPT
Who cannot join
- 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)
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- 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:
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Raevti Bole, 216-445-8640, BOLER@ccf.org
Petar Bajic, MD
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- 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
- Being tested
- Focused shockwave, Radial wave, Sham treatment
- Keywords
- shockwave, radial wave, pelvic floor physical therapy
- Medical subject headings
- Erectile Dysfunction, Spinocerebellar ataxia, autosomal recessive 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused shockwaveDevice
Storz Duolith SD-1 (Storz Medical, Tagerwilen, Switzerland)
Radial waveDevice
Zimmer enPuls Pro (Zimmer MedizinSysteme GmbH, Neu-Ulm, Germany)
Sham treatmentDevice
Handheld sham probe
| Study group | Role | What they receive |
|---|---|---|
| fSWT | Experimental | Focused Shock wave treatments Receives: Device: Focused shockwave |
| rWT | Active comparator | Radial wave treatments Receives: Device: Radial wave |
| Sham | Sham comparator | Sham treatments Receives: Device: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erectile Dysfunction
To evaluate change/minimum clinically important difference (MCID) of International Index of Erectile Function score. Score varies according to baseline ED severity, generally requiring higher value for more severe symptoms.
Measured: baseline, 3 and 6 months
Chronic Prostatitis/Chronic Pelvic Pain Syndrome:
To evaluate change/MCID in Chronic Prostatitis Symptom Index (CPSI) score. Score varies according to baseline ED severity, generally requiring higher value for more severe symptoms.
Measured: baseline, 3 and 6 months
Secondary outcomes (3)
Erectile Dysfunction
SEP- Sexual Encounter Profile Questionnaire (log diary 5-item questionnaire with yes/no questions after sexual attempt)
Measured: baseline, 3 and 6 months
Erectile Dysfunction
GAQ- Global Assessment Questionnaire. Two yes/no questions assessing for improvement in sexual function.
Measured: baseline, 3 and 6 months
Erectile Dysfunction
EHS- Erection Hardness Score measuring erection hardness with a higher score indicating more rigidity.
Measured: baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start19 Sep 2023
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction Due to Arterial InsufficiencyStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petar Bajic, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868668
- Sponsor's protocol ID
- 23-103
- Acronym
- Shockwave
- Status last verified
- Aug 2026
- First submitted
- 11 May 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05868668
- Acronym / sponsor ID
- Shockwave / 23-103
- Conditions
- 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
- Keywords
- shockwave, radial wave, pelvic floor physical therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fSWT | Experimental | Device: Focused shockwaveFocused Shock wave treatments |
| rWT | Active comparator | Device: Radial waveRadial wave treatments |
| Sham | Sham comparator | Device: Sham treatmentSham treatments |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult males ≥18 years old
- Chronic pelvic pain not explained by concurrent urinary tract infections. urine)
- Willing to do PFPT
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focused shockwaveStorz Duolith SD-1 (Storz Medical, Tagerwilen, Switzerland) | Device | fSWT |
| Radial waveZimmer enPuls Pro (Zimmer MedizinSysteme GmbH, Neu-Ulm, Germany) | Device | rWT |
| Sham treatmentHandheld sham probe | Device | Sham |
Primary outcome
Erectile Dysfunction
Time frame: baseline, 3 and 6 months
To evaluate change/minimum clinically important difference (MCID) of International Index of Erectile Function score. Score varies according to baseline ED severity, generally requiring higher value for more severe symptoms.
Chronic Prostatitis/Chronic Pelvic Pain Syndrome:
Time frame: baseline, 3 and 6 months
To evaluate change/MCID in Chronic Prostatitis Symptom Index (CPSI) score. Score varies according to baseline ED severity, generally requiring higher value for more severe symptoms.
3 secondary outcomes
Erectile Dysfunction
Time frame: baseline, 3 and 6 months
Erectile Dysfunction
Time frame: baseline, 3 and 6 months
Erectile Dysfunction
Time frame: baseline, 3 and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Petar Bajic, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused shockwave and Radial wave in people with Erectile Dysfunction Due to Arterial Insufficiency and Erectile Dysfunction, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petar Bajic (216-444-1231, bajicp@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erectile Dysfunction (time frame: baseline, 3 and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.