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

NCT05868668 | Recruiting FDA Device

• 1 other identifier: 23-103
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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; Erectile Dysfunction Due to Arterial Disease; Chronic Pelvic Pain Syndrome; Chronic Prostatitis; Erectile Dysfunction Following Radical Prostatectomy; Erectile Dysfunction Following Radiation Therapy; Erectile Dysfunction Due to Arterial Insufficiency

Keywords

shockwave; radial wave; pelvic floor physical therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  baseline, 3 and 6 months

Secondary Outcomes (3)

• Erectile Dysfunction

  baseline, 3 and 6 months

• Erectile Dysfunction

  baseline, 3 and 6 months

• Erectile Dysfunction

  baseline, 3 and 6 months

Study Arms (3)

fSWT

EXPERIMENTAL

Focused Shock wave treatments

Device: Focused shockwave

rWT

ACTIVE COMPARATOR

Radial wave treatments

Device: Radial wave

Sham

SHAM COMPARATOR

Sham treatments

Device: Sham treatment

Interventions

Focused shockwave DEVICE

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

fSWT

Radial wave DEVICE

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

rWT

Sham treatment DEVICE

Handheld sham probe

Sham

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction; Spinocerebellar ataxia, autosomal recessive 1

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Petar Bajic, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petar Bajic

CONTACT

216-444-1231; bajicp@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 22, 2023
• Study Start: September 19, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)