Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelv… (NCT05868668) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
United States186 participantsStarted 2023-09-19
Plain-language 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.
Who can participate
Age range40 Years
SexMALE
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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