PRP for Treatment of Peyronie's Disease

  • STATUS
    Recruiting
  • End date
    Apr 5, 2023
  • participants needed
    80
  • sponsor
    University of Miami
Updated on 5 May 2022

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).

Details
Condition Peyronie Disease, Sexual Dysfunction, Physiological, Sexual Dysfunction Male, Genital Diseases, Male
Treatment Saline solution, Autologous Platelet Rich Plasma
Clinical Study IdentifierNCT04512287
SponsorUniversity of Miami
Last Modified on5 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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