RECRUITING

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

Conditions

Peyronie Disease Sexual Dysfunctions, Psychological Genital Diseases, Male

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-10-02

Study Completion:2025-01-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05777031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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.

Inclusion Criteria

Exclusion 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

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.

Contacts and Locations

Study Contact

Thomas Masterson, MD

CONTACT

305-243-4562

tmasterson@med.miami.edu

Manuel Molina, MD

CONTACT

3052434872

m.molina.leyba@miami.edu

Principal Investigator

Thomas Masterson, MD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami - Desai Sethi Urology Institute

Miami, Florida, 33136

United States

University of Miami

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: University of Miami

Thomas Masterson, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-02

Study Completion Date2025-01-15

Study Record Updates

Study Start Date2023-10-02

Study Completion Date2025-01-15

Terms related to this study

Additional Relevant MeSH Terms

Peyronie Disease
Sexual Dysfunctions, Psychological
Genital Diseases, Male