Real-World Data Study to Understand Effectiveness of Treatments in Peyronie's Disease

Endo Pharmaceuticals29 enrolled

Overview

This is an observational study, meaning participants will not receive any investigational treatment as part of this study. Researchers will collect real-world data (RWD) to gain a more in-depth knowledge of the treatment of Peyronie's Disease (PD) to evaluate the management of PD.

Each participant of the study will have their data collected from the date of confirmed diagnosis of PD to the date of enrollment in the registry, post consent. Data will be collected from the participant's clinical records as well as from the participant directly. Data will be collected through Pulse Infoframe's technology platform.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Peyronie's Disease

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Any adult with a confirmed clinical diagnosis of PD. * Age 18 years (or age of majority in their jurisdiction) or older at time of enrollment. * Willing to participate in the registry (including completion of ePROs) and complete the informed consent form. * Having received PD treatment within 2 weeks before enrollment, at enrollment or any time after the date of enrollment. After a confirmed diagnosis of PD, not having received PD treatment. * Able to participate in English based registry. Key Exclusion criteria: * Not having a clinical diagnosis of PD. * Age less than 18 years. * Do not provide informed consent.

Locations (7)

Endo Pharmaceuticals Clinical Site 2

San Diego, California, United States

Endo Pharmaceuticals Clinical Site 3

Miami, Florida, United States

Endo Pharmaceuticals Clinical Site 6

Greenwood, Indiana, United States

Endo Pharmaceuticals Clinical Site 5

Lansing, Michigan, United States

Outcomes

Primary Outcomes

Number of Participants Receiving Each Treatment Type for PD

Time frame: Up to 12 months

Secondary Outcomes

Change from Baseline in Peyronie's Disease Questionnaire (PDQ) Score

Time frame: Up to 12 months

Change from Baseline in International Index of Erectile Function (IIEF) Score

Time frame: Up to 12 months

Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score

Time frame: Up to 12 months

Change from Baseline in Beck Anxiety Inventory (BAI) Scale Score

Time frame: Up to 12 months

Participant Satisfaction Questionnaire

Time frame: Up to 12 months

Number of Participants Receiving Post-Procedural Care by the Treating Physician

Time frame: Up to 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.