Peyronie's Disease
Conditions
Keywords
Real world data, Retrospective, Prospective, Registry
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Endo Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Receiving Each Treatment Type for PD | Up to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in International Index of Erectile Function (IIEF) Score | Up to 12 months |
| Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score | Up to 12 months |
| Change from Baseline in Peyronie's Disease Questionnaire (PDQ) Score | Up to 12 months |
| Participant Satisfaction Questionnaire | Up to 12 months |
| Number of Participants Receiving Post-Procedural Care by the Treating Physician | Up to 12 months |
| Change from Baseline in Beck Anxiety Inventory (BAI) Scale Score | Up to 12 months |
Countries
United States
Outcome results
None listed