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

Prior treatment

• Untreated hypogonadism (morning total testosterone \<300 ng/dL) or on androgen deprivation therapy in the last 12 months
• Known corporal veno-occlusive dysfunction based on prior Doppler penile ultrasound
• Patients currently using SSRI or psychotropic medication

Other illness

• 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)
• Peyronie's disease, palpable plaque or curvature/penile anatomic abnormality that affects penetrative intercourse to any degree
• History of non-superficial penile surgery (e.g, penile prosthesis, penectomy, plication, grafting)
• History of penile injury or trauma (e.g, priapism, penile fracture)
• Poorly controlled hypertension
• Severe cardiac disease or history of myocardial infarction
• History of psychiatric disorder including bipolar disorder, current moderate or severe depression
• Current acute prostatitis
  • Chronic Pelvic Pain Syndrome Group:
• 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)
• Acute prostatitis or any acute infection of the pelvic region
• History of pelvic trauma

Lab values

• If diabetic, HbA1c 8% or higher within the past 12 months

Other

• Predominately psychogenic ED based upon expert clinician opinion
• Use of intracavernosal injection for ED within the last year
• Current tobacco smoker, or has smoked in the past year
• Poorly controlled hyperlipidemia
• Severe ED based on IIEF-EF (score 10 or below)

• Adult males ≥18 years old
• Chronic pelvic pain not explained by concurrent urinary tract infections. urine)
• Willing to do PFPT

Criteria the registry did not label

• Erectile Dysfunction Group (ED) Inclusion Criteria (ED): (all of the following)
• 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