Recruiting

Low-Intensity Shockwave vs. Radial Wave

Sponsor:

The Cleveland Clinic

Code:

NCT05868668

Conditions

Erectile Dysfunction Due to Arterial Insufficiency

Erectile Dysfunction

Erectile Dysfunction Due to Arterial Disease

Chronic Pelvic Pain Syndrome

Chronic Prostatitis

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Focused shockwave

Radial wave

Sham treatment

Study Details

Brief 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.

Conditions

Erectile Dysfunction Due to Arterial Insufficiency

Erectile Dysfunction

Erectile Dysfunction Due to Arterial Disease

Chronic Pelvic Pain Syndrome

Chronic Prostatitis

Study ID

NCT05868668

Start date

Sep 19, 2023

Status verified date

Aug, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40+

Healthy Volunteers: Not accepted

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 Design

Enrollment

186 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: fSWT

Focused Shock wave treatments

active comparator: rWT

Radial wave treatments

sham comparator: Sham

Sham treatments

Interventions

Focused shockwave

Storz Duolith SD-1 (Storz Medical, Tagerwilen, Switzerland)

Radial wave

Zimmer enPuls Pro (Zimmer MedizinSysteme GmbH, Neu-Ulm, Germany)

Sham treatment

Handheld sham probe

Primary outcome measure

  • Erectile Dysfunction [ Time Frame: baseline, 3 and 6 months ]
  • Chronic Prostatitis/Chronic Pelvic Pain Syndrome: [ Time Frame: baseline, 3 and 6 months ]

Central Contacts and Locations

Central contacts

Locations

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Principal Investigator:

Petar Bajic, MD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • shockwave
  • radial wave
  • pelvic floor physical therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-08-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.