Project
Evaluation of InterStim Micro System Performance and Safety (ELITE) to Confirm Long-Term Outcomes
Completed · 2020 until 2024
Marti Lukas, Beutner Ulrich, Bischofberger Stephan, Widmann Bernhard
Type
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Units
Status
Start Date
End Date
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Study Design
Keywords
Brief description/objective
The indications under investigation are overactive bladder, fecal incontinence, and non-obstructive urinary retention. Refer to
geography-specific labeling for additional details on indications.
There are no investigational devices used in this study, all study products will be used in accordance with the product labeling.
Purpose: Post-market clinical follow-up to confirm long-term safety and performance of the InterStim Micro System for sacral neuromodulation.
Primary Objective for Fecal Incontinence:
• To demonstrate an improvement in Cleveland Clinic
Incontinence Score (CCIS) at 3 months post-implant compared
to baseline
Additional Measures:
• To characterize change in symptoms at follow-up visits
compared to baseline
• To characterize the change in Cleveland Clinic Incontinence
Score (CCIS) at follow-up visits compared to baseline
• To characterize the change in Fecal Incontinence Quality of
Life Questionnaire (FIQoL) at follow-up visits compared to
baseline
• To characterize Patient Global Impression of Improvement
(PGI-I) and patient satisfaction at follow-up visits