Clinical trial NCT05777031: 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
Overall status: RECRUITING
Phase: PHASE4
Conditions: Peyronie Disease
Sexual Dysfunctions, Psychological
Genital Diseases, Male
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Endo Pharmaceuticals
First posted: 2023-03-20
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Treatment Related Adverse Events
timeFrame: up to 6 months (post-intervention)
measure: Percent change of penile curvature in degrees.
timeFrame: Baseline up to 6 months
Secondary outcomes:
measure: Change in Peyronie's Disease Questionnaire (PDQ) sub-domain scores (Psychological and Physical Symptoms, Symptom Bother).
timeFrame: Baseline, 6 months.
measure: Changes in International Index of Erectile Function - Erectile Function (IIEF-EF) scores
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami - Desai Sethi Urology Institute
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Thomas Masterson, MD
role: PRINCIPAL_INVESTIGATOR
References: