Study Overview

Study Details

Study overview

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.

Randomized Controlled Trial of Focused Shockwave, Radial Wave, and Sham Therapy for Erectile Dysfunction and Pelvic Pain

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

Condition
Erectile Dysfunction Due to Arterial Insufficiency
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Cis-gendered heterosexual adult males ≥40 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) for at least 3 months
  • 4. PDE5I responsive or partially responsive ED (patients using PDE5I will be asked to discontinue PDE5I for 4 weeks prior to trial and remain off PDE5I for duration of 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. History of spinal cord injury, severe lumbosacral disorder (radiculopathy, spinal stenosis) or other neurological disease affecting erectile functions (Multiple sclerosis, Alzheimer's, Parkinsons disease)
  • 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 (penile prosthesis, penectomy, plication, grafting etc but not circumcision)
  • 6. History of penile injury or trauma (priapism, penile fracture)
  • 7. Use of intracavernosal injection for ED within the last year
  • 8. If diabetic, HbA1c 7.5 or higher within 3 months prior to trial
  • 9. Known corporal veno-occlusive dysfunction based on prior Doppler penile ultrasound
  • 10. Active smoker
  • 11. Poorly controlled hyperlipidemia
  • 12. Poorly controlled hypertension \>130/80 mmHg
  • 13. Severe cardiac disease or history of myocardial infarction
  • 14. History of psychiatric disorder including bipolar disorder, current moderate or severe depression; patients using SSRI or psychotropic medication
  • 15. Severe ED based on IIEF-EF (score 10 or below)
  • 16. Acute prostatitis

Ages Eligible for Study

40 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Cleveland Clinic,

Petar Bajic, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2025-06