Phase
Condition
Peyronie's Disease
Treatment
Collagenase Clostridium Histolyticum (CCH)
Clinical Study ID
Ages 18-75 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Be able to provide written informed consent
Have a diagnosis of PD with evidence of stable disease as determined by theinvestigator
Patient must have palpable penile plaque
Penile curvature deformity of >30° to <90°
Agree to comply with all study related tests/procedures.
Prior intralesional platelet rich plasma treatment within the past 18 months anddesire secondary treatment of penile curvature
Exclusion
Exclusion Criteria:
Previous penile surgery of any kind (except circumcision and condyloma removal),such as penile lengthening, penile cancer surgery, penile plication, grafting,penile prosthesis.
Previous intralesional injection therapy with CCH for PD within six months. Patientswith failed therapy greater than six months ago may be included.
Previous history of priapism or penile fracture
PD characterized by a ventral plaque
Severe erectile dysfunction as characterized with an IIEF score ≤ 12
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 investigationtimeframe that will interfere with autologous PRP injection therapy.
Have a serious comorbid illness/condition/behavior that, in the opinion of theinvestigator, may compromise the safety or compliance of the subject or precludesuccessful completion of the study.
Study Design
Connect with a study center
University of Miami
Miami, Florida 33136
United StatesActive - Recruiting
University of Miami - Desai Sethi Urology Institute
Miami, Florida 33136
United StatesActive - Recruiting
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