A Study to Create a Research Database by Gathering Information about Peyronie’s Disease and the Effects it has on Erectile Dysfunction
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 17-002350
Sponsor Protocol Number: 17-002350
About this study
The purpose of this investigation is to develop and maintain a database for patients with PD +/- ED in the five years preceding the introduction of collagenase histolyticum (2008-2013) in comparison to the five years following Xiaflex FDA approval (2013-2018).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Mayo Clinic Jacksonville patients seen in the Urology Department who underwent CDDU analysis for PD performed by a single surgeon (Dr. Gregory Broderick, PI) within the specified timeline.
Patients will include those that have received treatment of Xiaflex for PD since FDA approval.
Exclusion Criteria:
Excluded patients are those who have not received treatment of Xiaflex for PD by Dr. Gregory Broderick at Mayo Clinic Jacksonville within the specified timeframe.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Gregory Broderick, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available