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Compares treatment options for Erectile Dysfunction Due to Arterial Insufficiency
Official title Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
ClinicalTrials.gov ID: NCT05868668
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older, men only
You may be able to join if
- Erectile Dysfunction Group (ED) (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...
You likely can't join if
- (ED):
- Nerve-injury related ED (/spinal cord injury, severe lumbosacral disorder (radiculopathy, spinal stenosis) or other neurological disease affecting...
- 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)
See the full eligibility criteria
- Erectile Dysfunction Group (ED) (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...
- 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
- (ED):
- 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...
- 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: Inclusion Criteria (CPPS): (all of the following)
- Adult males ≥18 years old
- Chronic pelvic pain not explained by concurrent urinary tract infections. urine)
- Willing to do PFPT Exclusion criteria (CPPS):
- 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...
- Acute prostatitis or any acute infection of the pelvic region
- History of pelvic trauma
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.