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Study objectives: To report feasibility data for safety and effectiveness of the study device.
Study device: Nine Continents Medical implantable tibial nerve stimulator (ITNS) model 9C-680 with programmer model 9C-580.
Intended use: The study device is intended for treatment of the symptoms of overactive bladder (OAB), including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.
Type of design: Single-arm longitudinal design.
Study sites: Single site, in the United States.
Study duration: One year total, comprising six months for enrolling and implanting 10 subjects, and 26 weeks for follow-up.
Implantation and neuromodulation therapy
Nine Continents Medical, Inc.
Published on BioPortfolio: 2019-10-10T09:39:45-0400
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