Artificial Urinary Sphincter Clinical Outcomes (AUSCO) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to understand if the study device, the AMS 800 Artificial Urinary Sphincter (AUS), improves urinary incontinence in men.

What is the Condition Being Studied?

Urinary Incontinence

Who Can Participate in the Study?

-Male
-18 years of age and older
-Has had prostate surgery
-Incontinent

Age Group
Adults

What is Involved?

If you choose to join this study you will:
-Have the study device (AMS 800) placed into your body
-Complete questionnaires
-Keep a diary
-6 Months after the study device is removed, we will ask you complete more questionnaires and to keep another diary

Study Details

Full Title
Artificial Urinary Sphincter Clinical Outcomes
Principal Investigator
Protocol Number
IRB: PRO00104070
NCT: NCT04088331
Phase
Phase N/A
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698