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| Name | Class |
|---|---|
| Endo USA Inc., a Keenova Therapeutics Company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagenase Clostridium Histolyticum (CCH) | Drug | 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. |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Masterson, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami - Desai Sethi Urology Institute | Miami | Florida | 33136 | United States | ||
| University of Miami |
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|
| 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 |
| Miami |
| Florida |
| 33136 |
| United States |
| ID | Term |
|---|---|
| D010411 | Penile Induration |
| D020018 | Sexual Dysfunctions, Psychological |
| D005832 | Genital Diseases, Male |
| ID | Term |
|---|---|
| D010409 | Penile Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003012 | Microbial Collagenase |
| ID | Term |
|---|---|
| D017364 | Collagenases |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
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