WHAT IS THE ELITE STUDY?
The ELITE study is a research study (also known as a clinical trial) for people experiencing bladder or bowel control issues, specifically overactive bladder (OAB), urinary retention, or fecal incontinence. This study is designed to better understand an FDA-approved treatment called the InterStim™ Micro system. The InterStim™ Micro system delivers sacral neuromodulation, or SNM, is a fully implantable advanced therapy option that may help reduce bothersome bladder or bowel symptoms.
We are actively enrolling patients who have non-obstructive urinary retention or fecal incontinence.
WHO IS ELIGIBLE TO PARTICIPATE?
Your physician will assess if you are eligible for the ELITE study based on certain criteria.
YOU MAY BE ELIGIBLE IF:
- You are willing and able to receive treatment at one of our ELITE study locations.
- You are 18 years of age or older.
- You have tried other treatments and your doctor thinks you are a candidate for Medtronic bladder control or bowel control therapy delivered by the InterStim™ Micro system.
- You are willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol.
YOU ARE NOT ELIGIBLE IF:
- Your doctor does not recommend Medtronic bladder control or bowel control therapy delivered by the InterStim™ Micro system for you.
- You are a woman who is pregnant, or you are planning to become pregnant during the 2 years of the study.