Back to resultsSafety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease
Primary Purpose
Peyronie Disease, Sexual Dysfunctions, Psychological, Genital Diseases, Male
Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Collagenase Clostridium Histolyticum (CCH)
Sponsored by
About this trial
This is an interventional treatment trial for Peyronie Disease
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.
Sites / Locations
- University of Miami - Desai Sethi Urology Institute
- University of Miami
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Collagenase Clostridium Histolyticum (CCH) Group
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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).
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.
Full Information
NCT ID
NCT05777031
First Posted
March 8, 2023
Last Updated
September 14, 2023
Sponsor
University of Miami
Collaborators
Endo Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT05777031
Brief Title
Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease
Official Title
Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional Platelet Rich Plasma for Peyronie's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
July 15, 2024 (Anticipated)
Study Completion Date
January 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Endo Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peyronie Disease, Sexual Dysfunctions, Psychological, Genital Diseases, Male
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Collagenase Clostridium Histolyticum (CCH) Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Collagenase Clostridium Histolyticum (CCH)
Other Intervention Name(s)
Xiaflex
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Treatment Related Adverse Events
Description
To determine number of treatment related adverse events. Safety will be evaluated via the incidence of adverse events as assessed by treating physician
Time Frame
up to 6 months (post-intervention)
Title
Percent change of penile curvature in degrees.
Description
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.
Time Frame
Baseline up to 6 months
Secondary Outcome Measure Information:
Title
Change in Peyronie's Disease Questionnaire (PDQ) sub-domain scores (Psychological and Physical Symptoms, Symptom Bother).
Description
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).
Time Frame
Baseline, 6 months.
Title
Changes in International Index of Erectile Function - Erectile Function (IIEF-EF) scores
Description
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.
Time Frame
Baseline, 6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Masterson, MD
Phone
305-243-4562
Email
tmasterson@med.miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Molina, MD
Phone
3052434872
Email
m.molina.leyba@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Masterson, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami - Desai Sethi Urology Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas A Masterson, MD
Phone
305-243-6090
Email
tmasterson@miami.edu
First Name & Middle Initial & Last Name & Degree
Manuel Molina, MD
Phone
305-243-6090
Email
m.molina.leyba@miami.edu
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Masterson, MD
Phone
305-243-6090
Email
tmasterson@miami.edu
First Name & Middle Initial & Last Name & Degree
Thomas Masterson, MD
First Name & Middle Initial & Last Name & Degree
Manuel Molina, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Safety and Efficacy of Collagenase Clostridium Histolyticum After Prior Intralesional PRP for Peyronie's Disease
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