Comparing low-intensity shockwave and radial wave treatments for erectile dysfunction and pelvic pain

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

This study is testing whether focused shockwave therapy or radial wave therapy can help men with erectile dysfunction and people with chronic pelvic pain feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 186 (estimated)
• Ages: 40 Years and up
• Sex: Male
• Sponsor: The Cleveland Clinic (Academic / other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT05868668 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of focused shockwave therapy (fSWT) versus radial wave therapy (rWT) in treating erectile dysfunction and chronic pelvic pain syndrome. Participants will be randomly assigned to receive either fSWT, rWT, or a sham treatment in a double-blind manner. Those with erectile dysfunction will be randomized in a 2:2:1 ratio, while patients with chronic pelvic pain syndrome will be assigned to fSWT with pelvic floor physical therapy or sham treatment. The study will assess the relief of symptoms and overall effectiveness of these therapies.

Who should consider this trial

Good fit: Ideal candidates include cis-gendered heterosexual adult males aged 18 and older with mild to moderate organic erectile dysfunction or chronic pelvic pain syndrome.

Not a fit: Patients with nerve-injury related erectile dysfunction or those not meeting the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide new, effective treatment options for men suffering from erectile dysfunction and chronic pelvic pain.

How similar studies have performed: Previous studies have shown promise with shockwave therapies for erectile dysfunction, suggesting potential for success in this approach.

Eligibility criteria

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

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Petar Bajic, MD — The Cleveland Clinic
• Study coordinator: Petar Bajic

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; shockwave