Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn about the safety and side effects of intralesional collagenase clostridium histolyticum (CCH) injected into the Peyronies Disease (PD) plaque after receiving prior treatment with intralesional Platelet Rich Plasma (PRP) injections.

Official Title
-----------------
Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional Platelet Rich Plasma for Peyronie's Disease

Conditions
-----------------
Genital Diseases, Male, Peyronie Disease, Sexual Dysfunctions, Psychological

Intervention / Treatment
-----------------
* Drug: Collagenase Clostridium Histolyticum (CCH)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be able to provide written informed consent Have a diagnosis of PD with evidence of stable disease as determined by the investigator 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 and desire secondary treatment of penile curvature 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. Patients with 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 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collagenase Clostridium Histolyticum (CCH) Group<br>There will be 8 total treatments. These will follow the manufacturer protocol of 2 injections 24-72 hours apart (one cycle), followed by a 6-week break. This will total a maximum of 4 cycles. | Drug: Collagenase Clostridium Histolyticum (CCH)<br>* Injection of intralesional CCH (0.58mg) to the penile plaque at the point of maximal curvature. Second injection of each cycle will be injected 2-3mm apart from the prior injection.<br>* Other names: Xiaflex;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Treatment Related Adverse Events | To determine number of treatment related adverse events. Safety will be evaluated via the incidence of adverse events as assessed by treating physician | up to 6 months (post-intervention) | 
| Percent change of penile curvature in degrees. | Treatment efficacy of CCH 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. | Baseline up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Peyronie's Disease Questionnaire (PDQ) sub-domain scores (Psychological and Physical Symptoms, Symptom Bother). | Treatment efficacy will be assessed via the change 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). | Baseline, 6 months. | 
| Changes in International Index of Erectile Function - Erectile Function (IIEF-EF) scores | IIEF-EF is a 5-item subdomain self-evaluation questionnaire of erectile function. Each item is scored from 0-5 with the total score ranging from 0-25 with the higher score indicating better erectile function. | Baseline, 6 months |