Erectile Dysfunction Clinical Trial
Official title:
Randomized Controlled Trial of Focused Shockwave, Radial Wave, and Sham Therapy for Erectile Dysfunction and Pelvic Pain
NCT number | NCT05868668 |
Other study ID # | 23-103 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 19, 2023 |
Est. completion date | June 2025 |
Verified date | May 2023 |
Source | The Cleveland Clinic |
Contact | Petar Bajic |
Phone | 216-444-1231 |
bajicp[@]ccf.org | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 55 |
Est. completion date | June 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years and older |
Eligibility | Erectile dysfunction cohort Inclusion Criteria: 1. Cis-gendered heterosexual adult males =40 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) for at least 3 months 4. PDE5I responsive or partially responsive ED (patients using PDE5I will be asked to discontinue PDE5I for 4 weeks prior to trial and remain off PDE5I for duration of 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 Erectile dysfunction cohort Exclusion Criteria: 1. History of spinal cord injury, severe lumbosacral disorder (radiculopathy, spinal stenosis) or other neurological disease affecting erectile functions (Multiple sclerosis, Alzheimer's, Parkinsons disease) 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 (penile prosthesis, penectomy, plication, grafting etc but not circumcision) 6. History of penile injury or trauma (priapism, penile fracture) 7. Use of intracavernosal injection for ED within the last year 8. If diabetic, HbA1c 7.5 or higher within 3 months prior to trial 9. Known corporal veno-occlusive dysfunction based on prior Doppler penile ultrasound 10. Active smoker 11. Poorly controlled hyperlipidemia 12. Poorly controlled hypertension >130/80 mmHg 13. Severe cardiac disease or history of myocardial infarction 14. History of psychiatric disorder including bipolar disorder, current moderate or severe depression; patients using SSRI or psychotropic medication 15. Severe ED based on IIEF-EF (score 10 or below) 16. Acute prostatitis CP/CPPS cohort inclusion criteria: (all of the following) 1. Adult males =40 years old 2. Chronic pelvic pain with no obvious signs of infection in urine (<10 WBC per HPF in mid-stream urine) 3. Agreeable to undergo PFPT CP/CPPS cohort exclusion criteria: 1. History of spinal cord injury, severe lumbosacral disorder (radiculopathy, spinal stenosis), Multiple sclerosis, Alzheimer's, Parkinsons disease 2. Acute prostatitis or any acute infection of the pelvic region 3. History of pelvic trauma |
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Erectile Dysfunction | To evaluate change/minimum clinically important difference (MCID) of International Index of Erectile Function score. Score varies according to baseline ED severity, generally requiring higher value for more severe symptoms. | baseline, 3 and 6 months | |
Primary | Chronic Prostatitis/Chronic Pelvic Pain Syndrome: | To evaluate change/MCID in Chronic Prostatitis Symptom Index (CPSI) score. Score varies according to baseline ED severity, generally requiring higher value for more severe symptoms. | baseline, 3 and 6 months | |
Secondary | Erectile Dysfunction | SEP- Sexual Encounter Profile Questionnaire (log diary 5-item questionnaire with yes/no questions after sexual attempt) | baseline, 3 and 6 months | |
Secondary | Erectile Dysfunction | GAQ- Global Assessment Questionnaire. Two yes/no questions assessing for improvement in sexual function. | baseline, 3 and 6 months | |
Secondary | Erectile Dysfunction | EHS- Erection Hardness Score measuring erection hardness with a higher score indicating more rigidity. | baseline, 3 and 6 months |
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