Novel Treatment for Microvascular Erectile Dysfunction Combining Shockwave Therapy and Platelet Rich Plasma
Overview
- Phase
- Phase 1
- Intervention
- Shock Wave therapy (SWT)
- Conditions
- Erectile Dysfunction
- Sponsor
- University of Miami
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in IIEF-EF Scores
- Status
- Completed
- Last Updated
- last year
Overview
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
Investigators
Emad Ibrahim
Assistant Professor of Clinical Urology
University of Miami
Eligibility Criteria
Inclusion Criteria
- •Be 30 to 80 years of age (inclusive).
- •Be able to provide written informed consent.
- •Have a diagnosis of ED due to organic origin for at least 6 months prior to consent.
- •Sexually active in a stable, heterosexual relationship of more than three months duration.
- •IIEF-EF score 12-25 at screening
- •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.
- •Agree to comply with all study related tests/procedures.
Exclusion Criteria
- •Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
- •Previous history of priapism or penile fracture
- •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%).
- •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.
- •Psychogenic ED as determined by study investigator.
- •Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity) or neurological abnormalities in the treatment area.
- •Patients using Intracavernosal Injection (ICI) for management of ED
- •Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's disease.
- •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.
- •History of consistent treatment failure with Phosphodiesterase Type 5 (PDE5) inhibitors for therapy of ED.
Arms & Interventions
SWT plus PRP Group
Participants will receive weekly Shockwave Therapy (SWT) and Platelet Rich Plasma (PRP) for 5 weeks. SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. PRP will be administered on Week 1 and Week 5.
Intervention: Shock Wave therapy (SWT)
SWT plus PRP Group
Participants will receive weekly Shockwave Therapy (SWT) and Platelet Rich Plasma (PRP) for 5 weeks. SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. PRP will be administered on Week 1 and Week 5.
Intervention: Platelet Rich Plasma (PRP)
Sham SWT plus Placebo Saline Group
Participants will receive weekly Sham Shockwave Therapy (SWT) and Placebo Saline Intracavernosal Injection (ICI) for 5 weeks. Sham SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. Placebo Saline ICI will be administered on Week 1 and Week 5.
Intervention: Sham SWT
Sham SWT plus Placebo Saline Group
Participants will receive weekly Sham Shockwave Therapy (SWT) and Placebo Saline Intracavernosal Injection (ICI) for 5 weeks. Sham SWT will be administered weekly on Weeks 1, 2, 3, 4, and 5. Placebo Saline ICI will be administered on Week 1 and Week 5.
Intervention: Placebo Saline
Outcomes
Primary Outcomes
Change in IIEF-EF Scores
Time Frame: Baseline, Month 3, Month 6
International Index of Erectile Function - Erectile Function Subdomain Score (IIEF-EF) is a 5-item subdomain self- evaluation questionnaire of erectile function with a total score ranging from 0-25 with the higher score indicating better erectile function.
Percentage of participants achieving MCID in IIEF-EF
Time Frame: Baseline, Month 3, Month 6
IIEF-EF is a 5-item subdomain self- evaluation questionnaire of erectile function with a total score ranging from 0-25 with the higher score indicating better erectile function. Mild Clinically Important Difference (MCID) is attained via an increase of 2 points in IIEF-EF score for participants with mild ED and an increase of 5 points for participants with moderate ED.
Penile Blood Flow
Time Frame: Baseline, Month 6
Penile Blood Flow will be reported as Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV), both assessed in cm/sec, via Penile Doppler ultrasonography
Circulating Angiogenic Factor levels
Time Frame: Baseline, Month 3, Month 6
Circulating angiogenic factor levels including Vascular Endothelial Growth Factor (VEGF), Stromal Cell Derived Factor-1 (SDF-1 alpha) and Stem cell Factor (SCF), all reported in pg/mL, will be assessed via blood samples
Secondary Outcomes
- Number of participants reporting a decrease or discontinue in use of PDE5 inhibitors(Baseline, Month 3)