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PRP for Treatment of Peyronie's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04512287
Recruitment Status : Not yet recruiting
First Posted : August 13, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Ranjith Ramasamy, MD, University of Miami

Brief Summary:
The purpose of this study is to learn about the effects of Platelet-Rich Plasma (PRP) injection in men with Peyronie's Disease (PyD).

Condition or disease Intervention/treatment Phase
Peyronie Disease Sexual Dysfunction, Physiological Sexual Dysfunction Male Genital Diseases, Male Drug: Autologous Platelet Rich Plasma Other: Saline Solution Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo Controlled, Crossover Trial on Safety and Efficacy of Autologous Platelet-Rich Plasma for Treatment of Peyronie's Disease
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2023

Arm Intervention/treatment
Experimental: Experimental: Autologous PRP followed by Placebo Group
Participants in this group will receive the autologous intervention first, followed by the placebo intervention 6 months later.
Drug: Autologous Platelet Rich Plasma
2 sessions of Autologous PRP will be administered 15 days apart. Each injection will be 0.5 mL of PRP injected into the Peyronie's disease penile plaque.
Other Name: PRP

Other: Saline Solution
2 sessions of saline injection will be administered 15 days apart. Each injection will be 0.5 mL of normal saline injected into the Peyronie's disease penile plaque.

Experimental: Experimental: Placebo followed by Autologous PRP Group
Participants in this group will receive the placebo intervention first, followed by the Autologous PRP intervention 6 months later.
Drug: Autologous Platelet Rich Plasma
2 sessions of Autologous PRP will be administered 15 days apart. Each injection will be 0.5 mL of PRP injected into the Peyronie's disease penile plaque.
Other Name: PRP

Other: Saline Solution
2 sessions of saline injection will be administered 15 days apart. Each injection will be 0.5 mL of normal saline injected into the Peyronie's disease penile plaque.




Primary Outcome Measures :
  1. Percentage of subjects in each group who attain degree change in penile curvature. [ Time Frame: 12 months ]
    Treatment efficacy of PRP will be assessed via the percentage of participants achieving degree change in penile curvature from baseline. Degree of curvature will be measured using a goniometer with the aid of injection of vasoactive substance into the penis.

  2. Percentage of subjects achieving any decrease in PDQ sub-domain scores (Psychological and Physical Symptoms, Symptom Bother). [ Time Frame: 12 months ]
    Treatment efficacy will be assessed via the percentage of participants achieving any decrease in Peyronie's disease Questionnaire (PDQ) sub-domain scoring from baseline. The sub-domains that will be assessed in primary outcome is Psychological and Physical Symptoms and Symptom Bother. PDQ is a validated 15-item questionnaire that assess Psychological and Physical Symptoms, Symptom Bother, and Penile Pain subdomains. The Psychological and Physical Symptoms subdomain is measured from 0 to 24 (most severe symptoms). Symptom Bother subdomain is measured from 0 to 30 (most severe pain).


Secondary Outcome Measures :
  1. Incidence of adverse events in all patients [ Time Frame: Baseline, 6 months (post-intervention) ]
    Safety will be evaluated via the incidence of adverse events as assessed by treating physician



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be Male
  2. Be 18 to 75 years of age (inclusive).
  3. Be able to provide written informed consent
  4. Have a diagnosis of PD with evidence of active or stable disease as determined by the investigator
  5. Penile curvature deformity of >30° to <120°
  6. 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 intralesional injection therapy (such as Xiaflex) for PD.
  3. Previous history of priapism or penile fracture
  4. PD characterized by a ventral plaque
  5. Severe erectile dysfunction as characterized with an International Index of Erectile Function (IIEF) score ≤ 16
  6. Actively on anticoagulation during time frame of injections (aspirin 81 mg will be eligible for therapy)
  7. Hour-glass deformity
  8. Unwilling to participate
  9. Medically unfit for sexual intercourse as deemed by the principal investigator
  10. Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with autologous PRP injection therapy.
  11. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04512287


Contacts
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Contact: Kevin Chu, MD 305-243-4562 kevin.chu@jhsmiami.org
Contact: Ranjith Ramasamy, MD 305-243-4562 ramasamy@miami.edu

Locations
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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Contact: Kevin Chu, MD    305-243-4562    kevin.chu@jhsmiami.org   
Principal Investigator: Ranjith Ramasamy, MD         
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Ranjith Ramasamy, MD University of Miami
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Responsible Party: Ranjith Ramasamy, MD, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT04512287    
Other Study ID Numbers: 20200779
First Posted: August 13, 2020    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Ranjith Ramasamy, MD, University of Miami:
PD
PyD
PRP
Additional relevant MeSH terms:
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Penile Induration
Sexual Dysfunction, Physiological
Penile Diseases
Connective Tissue Diseases