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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05777031
Other study ID # 20221234
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date October 2, 2023
Est. completion date January 15, 2025

Study information

Verified date November 2023
Source University of Miami
Contact Thomas Masterson, MD
Phone 305-243-4562
Email tmasterson@med.miami.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 22
Est. completion date January 15, 2025
Est. primary completion date July 15, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Be able to provide written informed consent 2. Have a diagnosis of PD with evidence of stable disease as determined by the investigator 3. Patient must have palpable penile plaque 4. Penile curvature deformity of >30° to <90° 5. Agree to comply with all study related tests/procedures. 6. Prior intralesional platelet rich plasma treatment within the past 18 months and desire secondary treatment of penile curvature Exclusion Criteria: 1. Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting, penile prosthesis. 2. Previous intralesional injection therapy with CCH for PD within six months. Patients with failed therapy greater than six months ago may be included. 3. Previous history of priapism or penile fracture 4. PD characterized by a ventral plaque 5. Severe erectile dysfunction as characterized with an IIEF score = 12 6. Hour-glass deformity 7. Unwilling to participate 8. Medically unfit for sexual intercourse as deemed by the principal investigator 9. Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with autologous PRP injection therapy. 10. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Collagenase Clostridium Histolyticum (CCH)
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.

Locations

Country Name City State
United States University of Miami Miami Florida
United States University of Miami - Desai Sethi Urology Institute Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Miami Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 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.
Secondary 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
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