Project

Evaluation of InterStim Micro System Performance and Safety (ELITE) to Confirm Long-Term Outcomes

Aborted · 2020 until 2022

Type
Clinical Studies
Range
Multicentric, KSSG as participating partner
Units
Status
Aborted
Start Date
2020
End Date
2022
Financing
Industry
Study Design
prospective, multicenter, global, single-arm, open-label, post market clinical follow-up study
Keywords
fecal incontinence, sacral nerve modulation, SNM, Medtronic, InterStim Micro
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