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

NCT05048667 | Completed Phase 1 Results DMC FDA Drug FDA Device

• 2 other identifiers: 20210887R01DK130991
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Serious Adverse Events (TE-SAEs) During the Study Period.

  A treatment emergent serious adverse event (TE-SAE) is defined as any serious adverse event for which there is a reasonable possibility that the investigational product caused the adverse event. For the purposes of safety reporting, "a reasonable possibility" means there is evidence to suggest a causal relationship between the study product/procedures and the adverse event.

  Baseline, Month 3

Secondary Outcomes (3)

• Change in IIEF-EF Scores

  Baseline, Month 6

• Percentage of Participants Achieving MCID in IIEF-EF at Any Post-treatment Timepoint in Each Group.

  Baseline, Month 3, or Month 6

• Percentage of Participants Who Either Decrease or Discontinue Use of PDE5i After Three Months Post-therapy Compared to Control Group

  Baseline, Month 3

Study Arms (2)

SWT plus PRP Group

EXPERIMENTAL

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.

Device: Shock Wave therapy (SWT); Drug: Platelet Rich Plasma (PRP)

Sham SWT plus Placebo Saline Group

PLACEBO COMPARATOR

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.

Other: Sham SWT; Other: Placebo Saline

Interventions

Shock Wave therapy (SWT) DEVICE

Each SWT will administer 720 shocks in the treatment arm. Total of 3600 shocks are given over 5 weeks treatment period.

SWT plus PRP Group

Platelet Rich Plasma (PRP) DRUG

5 mL PRP will be administered via intracavernous injection

SWT plus PRP Group

Sham SWT OTHER

Sham Shockwave Therapy will be administered in the sham arm.

Sham SWT plus Placebo Saline Group

Placebo Saline OTHER

5 mL Placebo saline will be administered via intracavernous injection in the sham arm.

Sham SWT plus Placebo Saline Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be Male
• 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.

You may not qualify if:

• 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.
• 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.
• Hemoglobin a1c \>9%.

Sponsors & Collaborators

• University of Miami: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Related Publications (9)

• 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.

  PMID: 24080861 BACKGROUND

• 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.

  PMID: 19468902 BACKGROUND

• 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.

  PMID: 25164150 BACKGROUND

• 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.

  PMID: 25184132 BACKGROUND

• 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.

  PMID: 16174548 BACKGROUND

• 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.

  PMID: 1615601 BACKGROUND

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

  PMID: 10037356 BACKGROUND

• 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.

  PMID: 20134096 BACKGROUND

• Saltzman RG, Molina ML, Ledesma BR, Ibrahim E, Masterson TA, Ramasamy R. Rationale and Design for the COCKTAIL Trial: A Single-center, Randomized, Double-blind, Sham-controlled Study Combining Shockwave Therapy and Platelet-rich Plasma for Erectile Dysfunction. Eur Urol Focus. 2023 Jan;9(1):8-10. doi: 10.1016/j.euf.2022.09.015. Epub 2022 Oct 22.

  PMID: 36280578 DERIVED

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Emad Ibrahim
• Organization: University of Miami, Miller School of Medicine - Desai Sethi Urology Institute (DSUI)

eibrahim@miami.edu

305-243-6090

Study Officials

• Emad Ibrahim, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Urology

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 17, 2021
• Study Start: June 27, 2022
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: May 22, 2026
• Results First Posted: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)