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

Launched by THE CLEVELAND CLINIC · May 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two types of treatments—low-intensity shockwave therapy and radial wave therapy—for men experiencing erectile dysfunction (ED) and chronic pelvic pain. The goal is to find out which treatment is more effective in helping relieve these conditions. Men who are at least 40 years old, have been in a stable relationship for over three months, and have mild to moderate ED symptoms may be eligible to participate. It's important that participants are willing to try having sexual intercourse at least four times a month and meet specific health criteria.

If you decide to join the trial, you will be randomly assigned to receive either one of the treatments or a placebo (a "sham" treatment that looks like the real therapy but has no therapeutic effect). Participants will be monitored throughout the study for any changes in their symptoms. Remember, certain health conditions and treatments may disqualify you from participating, so it's best to discuss any concerns with your doctor. This study could offer new insights into treating ED and pelvic pain, potentially benefiting many men facing these challenges.

Gender

MALE

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