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

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.

Study Overview

• Status: Recruiting
• Conditions: Erectile Dysfunction; Chronic Prostatitis; Chronic Pelvic Pain Syndrome; Erectile Dysfunction Following Radical Prostatectomy; Erectile Dysfunction Following Radiation Therapy; Erectile Dysfunction Due to Arterial Insufficiency; Erectile Dysfunction Due to Arterial Disease
• Intervention / Treatment: Device: Focused shockwave; Device: Radial wave; Device: Sham treatment

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 Type: Interventional
• Enrollment (Estimated): 186
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Petar Bajic; Phone Number: 216-444-1231; Email: bajicp@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Foundation
      • Principal Investigator: Petar Bajic, MD
      • Contact: Raevti Bole; Phone Number: 216-445-8640; Email: BOLER@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fSWT; Focused Shock wave treatments	Device: Focused shockwave; Storz Duolith SD-1 (Storz Medical, Tagerwilen, Switzerland)
Active Comparator: rWT; Radial wave treatments	Device: Radial wave; Zimmer enPuls Pro (Zimmer MedizinSysteme GmbH, Neu-Ulm, Germany)
Sham Comparator: Sham; Sham treatments	Device: Sham treatment; Handheld sham probe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erectile Dysfunction	SEP- Sexual Encounter Profile Questionnaire (log diary 5-item questionnaire with yes/no questions after sexual attempt)	baseline, 3 and 6 months
Erectile Dysfunction	GAQ- Global Assessment Questionnaire. Two yes/no questions assessing for improvement in sexual function.	baseline, 3 and 6 months
Erectile Dysfunction	EHS- Erection Hardness Score measuring erection hardness with a higher score indicating more rigidity.	baseline, 3 and 6 months

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Petar Bajic, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: shockwave; pelvic floor physical therapy; radial wave
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Erectile Dysfunction; Spinocerebellar ataxia, autosomal recessive 1
• Other Study ID Numbers: 23-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No