Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain

NCT ID: NCT05868668

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-19
• Study Completion Date: 2026-06-30

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.

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; Erectile Dysfunction Following Radiation Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

fSWT

Focused Shock wave treatments

Group Type: EXPERIMENTAL

Focused shockwave

Intervention Type: DEVICE

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

rWT

Radial wave treatments

Group Type: ACTIVE_COMPARATOR

Radial wave

Intervention Type: DEVICE

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

Sham

Sham treatments

Group Type: SHAM_COMPARATOR

Sham treatment

Intervention Type: DEVICE

Handheld sham probe

Interventions

Focused shockwave

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

Intervention Type: DEVICE

Radial wave

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

Intervention Type: DEVICE

Sham treatment

Handheld sham probe

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

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

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:

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Petar Bajic, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Petar Bajic

Role: CONTACT

bajicp@ccf.org

216-444-1231

Facility Contacts

Raevti Bole

Role: primary

BOLER@ccf.org

216-445-8640

Other Identifiers

23-103

Identifier Type: -

Identifier Source: org_study_id