RecruitingNot ApplicableNCT05868668

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

Randomized Controlled Trial of Focused Shockwave, Radial Wave, and Sham Therapy for Erectile Dysfunction and Focused Shockwave and Sham Therapy for Chronic Pelvic Pain Syndrome in Patients With and Without History of Prostate Cancer

Sponsor

The Cleveland Clinic

Enrollment

186 participants

Start Date

Sep 19, 2023

Study Type

INTERVENTIONAL

Conditions

Erectile Dysfunction Erectile Dysfunction Following Radiation Therapy Erectile Dysfunction Following Radical Prostatectomy Erectile Dysfunction Due to Arterial Insufficiency Erectile Dysfunction Due to Arterial Disease Chronic Pelvic Pain Syndrome Chronic Prostatitis

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.

Eligibility

Sex: MALEMin Age: 40 Years

Inclusion Criteria9

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

Exclusion Criteria21

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
History of non-superficial penile surgery (e.g, penile prosthesis, penectomy, plication, grafting)
History of penile injury or trauma (e.g, priapism, penile fracture)
Use of intracavernosal injection for ED within the last year
If diabetic, HbA1c 8% or higher within the past 12 months
Known corporal veno-occlusive dysfunction based on prior Doppler penile ultrasound
Current tobacco smoker, or has smoked in the past year
Poorly controlled hyperlipidemia
Poorly controlled hypertension
Severe cardiac disease or history of myocardial infarction
History of psychiatric disorder including bipolar disorder, current moderate or severe depression
Patients currently using SSRI or psychotropic medication
Severe ED based on IIEF-EF (score 10 or below)
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