Study Evaluating the InterStim Micro System Performance and Safety (ELITE)

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Study Evaluating the InterStim Micro System Performance and Safety (ELITE)

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clinicaltrials.gov

Eligibility

Inclusion Criteria

All Cohorts
1. Subjects 18 years of age or older
2. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling

Overactive Bladder (OAB) Cohort
1. Diagnosis of OAB as demonstrated by a 3-day voiding diary with >/= 8 urgency frequency episodes per day and/or by having a minimum of 3 episodes of urinary urge incontinence in 72 hours

Fecal Incontinence Cohort
1. Diagnosis of fecal incontinence as demonstrated by a 7-day bowel diary as >/= 2 incontinent episodes of more than staining (i.e. either slight, moderate or severe soiling)

Non-Obstructive Urinary Retention (NOUR) Cohort
1. Diagnosis of NOUR as demonstrated by a 7-day urinary voiding diary with a minimum of 5 clean intermittent self-catheterizations
2. Chronic NOUR with an elevated post-void residual (PVR) that has persisted for at least six months and is documented on two or more separate occasions.

Exclusion Criteria

All Cohorts
1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury
2. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy
3. Women who are pregnant or planning to become pregnant

Specific to OAB Cohort
1. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
2. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
3. Have had treatment of urinary symptoms with botulinum toxin therapy in the past 12 months

Specific to Fecal Incontinence Cohort
1. Uncorrected high grade internal rectal prolapse

Specific to Non-Obstructive Urinary Retention Cohort
1. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)

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