InterStim Micro Post Market Clinical Follow-up Study (ELITE) (NCT04506866) | Clinical Trial Compass
TerminatedNot Applicable
InterStim Micro Post Market Clinical Follow-up Study (ELITE)
Stopped: Due to the extension of the clinical study duration and to avoid further delaying the reporting of results.
United States148 participantsStarted 2020-08-25
Plain-language summary
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the InterStim Micro System for sacral neuromodulation.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Have a diagnosis of OAB as demonstrated on a 3-day voiding diary with greater than or equal to 8 urgency frequency episodes per day and/or by having a minimum of 3 episodes of urinary urge incontinence in 72 hours
✓. Subjects 18 years of age or older
✓. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro System labeling
✓. Willing and able to accurately complete study diaries, questionnaires, attend visits, device recharging and comply with the study protocol
✓. Willing and able to provide signed and dated informed consent
Exclusion criteria
✕. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia)
✕. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
✕. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
✕. Have had treatment of urinary symptoms with botulinum toxin therapy in the past 12 months
✕. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic diathermy
✕. Women who are pregnant or planning to become pregnant
. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
✕. Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.