NCT05868668 Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
| NCT ID | NCT05868668 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Erectile Dysfunction Due to Arterial Insufficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 186 participants |
| Start Date | 2023-09-19 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 186 participants in total. It began in 2023-09-19 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Petar Bajic, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT05868668 clinical trial?
This trial is open to male participants only, aged 40 Years or older, studying Erectile Dysfunction Due to Arterial Insufficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05868668 currently recruiting?
Yes, NCT05868668 is actively recruiting participants. Contact the research team at bajicp@ccf.org for enrollment information.
Where is the NCT05868668 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT05868668 clinical trial?
NCT05868668 is sponsored by The Cleveland Clinic. The principal investigator is Petar Bajic, MD at The Cleveland Clinic. The trial plans to enroll 186 participants.