Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Focused shockwave
  • Radial wave
  • Sham treatment

Treatment groups

186 Participants
are divided into 3 treatment groups

Locations

1
Cleveland Clinic Foundation44195, ClevelandOhio, United States

Sponsors and collaborators

The Cleveland Clinic

Lead sponsor

Source ClinicalTrials.gov