Clinical trial NCT05048667: Shockwave Therapy and Platelet Rich Plasma for the Treatment of Erectile Dysfunction
Official title: Novel Treatment for Microvascular Erectile Dysfunction Combining Shockwave Therapy and Platelet Rich Plasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Erectile Dysfunction
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-09-17
Enrollment: 60
Sex: MALE
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to evaluate whether the combination of Shock Wave Therapy (SWT) with Platelet Rich Plasma (PRP) is synergistic and can reverse the pathology of microvascular Erectile Dysfunction (ED) and enhance erectile function by improving vasodilation, and endothelial function


Eligibility criteria: Inclusion Criteria:

1. Be Male
2. Be 30 to 80 years of age (inclusive).
3. Be able to provide written informed consent.
4. Have a diagnosis of ED due to organic origin for at least 6 months prior to consent.
5. Sexually active in a stable, heterosexual relationship of more than three months duration.
6. IIEF-EF score 12-25 at screening
7. Agree to attempt sexual intercourse at least 4 times per month for the duration of the study without being under the influence of alcohol or recreational drugs.
8. Agree to comply with all study related tests/procedures.

Exclusion Criteria:

1. Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
2. Previous history of priapism or penile fracture
3. Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (±5%) (indicative of untreated hypogonadism), or greater than 1197 ng/dL (±5%).
4. Current or previous hormone usage, other than prescribed testosterone, clomiphene or thyroid medication. (Subjects with prior or current use of hormonal treatment for prostate cancer are also excluded.
5. Psychogenic ED as determined by study investigator.
6. Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity) or neurological abnormalities in the treatment area.
7. Patients using Intracavernosal Injection (ICI) for management of ED
8. Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's disease.
9. Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
10. History of consistent treatment failure with Phosphodiesterase Type 5 (PDE5) inhibitors for therapy of ED.
11. Any history of significant psychiatric disease, such as bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity. Patients who are currently using Selective Serotonin Reuptake Inhibitors (SSRI) or psychotropic medications.
12. Hemoglobin a1c \>9%.

Primary outcomes:
measure: Change in IIEF-EF Scores
timeFrame: Baseline, Month 3, Month 6
measure: Percentage of participants achieving MCID in IIEF-EF
timeFrame: Baseline, Month 3, Month 6
measure: Penile Blood Flow
timeFrame: Baseline, Month 6
measure: Circulating Angiogenic Factor levels
timeFrame: Baseline, Month 3, Month 6
Secondary outcomes:
measure: Number of participants reporting a decrease or discontinue in use of PDE5 inhibitors
timeFrame: Baseline, Month 3
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Emad Ibrahim, MD
role: PRINCIPAL_INVESTIGATOR
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