Patient Outcomes following Artificial Urinary Sphincter Placement in Male Patients
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
- Rochester, Minnesota: 13-001920
Sponsor Protocol Number: 13-001920
About this study
The purpose of this study is to create a Mayo Clinic AUS research database with follow-up through 4 months. To eventually evaluate other risk factors for AUS complications, including prior treatments, comorbidities and obesity.
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:
- Males who have developed stress urinary incontinence (SUI) following either radical prostatectomy and/or radiation therapy for prostate cancer
- Males who have developed SUI following transurethral resection for benign prostate enlargement.
- All patients must be otherwise candidates for the artificial Urinary Sphincter (AUS)
- Must pass preoperative evaluation and have their artificial Urinary Sphincter (AUS) at Mayo Clinic
Exclusion Criteria:
- Male patients will be included in the database since the number of female artificial urinary sphincter cases is exceedingly rare with less than one/5 years
- Subjects who refuse access to their records for research
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Daniel Elliott, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available