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
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