Shockwave Therapy and Platelet Rich Plasma for the Treatment of Erectile Dysfunction

Erectile Dysfunction Clinical Trial

— COCKTAIL  

Official title:

Novel Treatment for Microvascular Erectile Dysfunction Combining Shockwave Therapy and Platelet Rich Plasma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05048667
• Other study ID #: 20210887
• Secondary ID: R01DK130991
• Status: Recruiting
• Phase: Phase 1
• Start date: June 27, 2022
• Est. completion date: December 10, 2024

Study information

• Verified date: May 2024
• Source: University of Miami
• Contact: Manuel Molina, MD
• Phone: 305-243-4873
• Email: m.molina.leyba[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 10, 2024
• Est. primary completion date: December 10, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 80 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• Shock Wave therapy (SWT)
Each SWT will administer 720 shocks in the treatment arm. Total of 3600 shocks are given over 5 weeks treatment period.

Drug:
• Platelet Rich Plasma (PRP)
5 mL PRP will be administered via intracavernous injection

Other:
• Sham SWT
Sham Shockwave Therapy will be administered in the sham arm.
• Placebo Saline
5 mL Placebo saline will be administered via intracavernous injection in the sham arm.

Locations

Country	Name	City	State
United States	University of Miami Miller School of Medicine	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (8)

Andia I, Maffulli N. Platelet-rich plasma for managing pain and inflammation in osteoarthritis. Nat Rev Rheumatol. 2013 Dec;9(12):721-30. doi: 10.1038/nrrheum.2013.141. Epub 2013 Oct 1. — View Citation

Haupt G, Haupt A, Ekkernkamp A, Gerety B, Chvapil M. Influence of shock waves on fracture healing. Urology. 1992 Jun;39(6):529-32. doi: 10.1016/0090-4295(92)90009-l. — View Citation

Kikuchi Y, Ito K, Ito Y, Shiroto T, Tsuburaya R, Aizawa K, Hao K, Fukumoto Y, Takahashi J, Takeda M, Nakayama M, Yasuda S, Kuriyama S, Tsuji I, Shimokawa H. Double-blind and placebo-controlled study of the effectiveness and safety of extracorporeal cardiac shock wave therapy for severe angina pectoris. Circ J. 2010 Mar;74(3):589-91. doi: 10.1253/circj.cj-09-1028. Epub 2010 Feb 4. — View Citation

Melman A, Gingell JC. The epidemiology and pathophysiology of erectile dysfunction. J Urol. 1999 Jan;161(1):5-11. — View Citation

Randelli P, Randelli F, Ragone V, Menon A, D'Ambrosi R, Cucchi D, Cabitza P, Banfi G. Regenerative medicine in rotator cuff injuries. Biomed Res Int. 2014;2014:129515. doi: 10.1155/2014/129515. Epub 2014 Aug 13. — View Citation

Sampson S, Gerhardt M, Mandelbaum B. Platelet rich plasma injection grafts for musculoskeletal injuries: a review. Curr Rev Musculoskelet Med. 2008 Dec;1(3-4):165-74. doi: 10.1007/s12178-008-9032-5. — View Citation

Vlachopoulos C, Rokkas K, Ioakeimidis N, Aggeli C, Michaelides A, Roussakis G, Fassoulakis C, Askitis A, Stefanadis C. Prevalence of asymptomatic coronary artery disease in men with vasculogenic erectile dysfunction: a prospective angiographic study. Eur Urol. 2005 Dec;48(6):996-1002; discussion 1002-3. doi: 10.1016/j.eururo.2005.08.002. Epub 2005 Aug 24. — View Citation

Xie X, Zhang C, Tuan RS. Biology of platelet-rich plasma and its clinical application in cartilage repair. Arthritis Res Ther. 2014 Feb 25;16(1):204. doi: 10.1186/ar4493. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in IIEF-EF Scores	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.	Baseline, Month 3, Month 6
Primary	Percentage of participants achieving MCID in IIEF-EF	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.	Baseline, Month 3, Month 6
Primary	Penile Blood Flow	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	Baseline, Month 6
Primary	Circulating Angiogenic Factor levels	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	Baseline, Month 3, Month 6
Secondary	Number of participants reporting a decrease or discontinue in use of PDE5 inhibitors	The number of participants reporting a decrease or discontinue in use of PDE5 inhibitors will be reported	Baseline, Month 3