Shockwave Therapy and Platelet Rich Plasma for the Treatment of Erectile Dysfunction
- Conditions
- Erectile Dysfunction
- Registration Number
- NCT05048667
- Lead Sponsor
- University of Miami
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Male
- Target Recruitment
- 60
Inclusion Criteria:<br><br> 1. Be Male<br><br> 2. Be 30 to 80 years of age (inclusive).<br><br> 3. Be able to provide written informed consent.<br><br> 4. Have a diagnosis of ED due to organic origin for at least 6 months prior to consent.<br><br> 5. Sexually active in a stable, heterosexual relationship of more than three months<br> duration.<br><br> 6. IIEF-EF score 12-25 at screening<br><br> 7. Agree to attempt sexual intercourse at least 4 times per month for the duration of<br> the study without being under the influence of alcohol or recreational drugs.<br><br> 8. Agree to comply with all study related tests/procedures.<br><br>Exclusion Criteria:<br><br> 1. Previous penile surgery of any kind (except circumcision and condyloma removal),<br> such as penile lengthening, penile cancer surgery, penile plication, grafting.<br><br> 2. Previous history of priapism or penile fracture<br><br> 3. Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL<br> (±5%) (indicative of untreated hypogonadism), or greater than 1197 ng/dL (±5%).<br><br> 4. Current or previous hormone usage, other than prescribed testosterone, clomiphene or<br> thyroid medication. (Subjects with prior or current use of hormonal treatment for<br> prostate cancer are also excluded.<br><br> 5. Psychogenic ED as determined by study investigator.<br><br> 6. Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual<br> activity) or neurological abnormalities in the treatment area.<br><br> 7. Patients using Intracavernosal Injection (ICI) for management of ED<br><br> 8. Patients with generalized polyneuropathy, or neurological conditions irrespective of<br> cause, such as severe diabetes, multiple sclerosis or Parkinson's disease.<br><br> 9. Have a serious comorbid illness/condition/behavior that, in the opinion of the<br> investigator, may compromise the safety or compliance of the subject or preclude<br> successful completion of the study.<br><br> 10. History of consistent treatment failure with Phosphodiesterase Type 5 (PDE5)<br> inhibitors for therapy of ED.<br><br> 11. Any history of significant psychiatric disease, such as bipolar disorder or<br> psychosis, greater than one lifetime episode of major depression, current depression<br> of moderate or greater severity. Patients who are currently using Selective<br> Serotonin Reuptake Inhibitors (SSRI) or psychotropic medications.<br><br> 12. Hemoglobin a1c >9%.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in IIEF-EF Scores;Percentage of participants achieving MCID in IIEF-EF;Penile Blood Flow;Circulating Angiogenic Factor levels
- Secondary Outcome Measures
Name Time Method Number of participants reporting a decrease or discontinue in use of PDE5 inhibitors