Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)
Abstract
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.
Conditions: Overactive Bladder.
Primary outcome: Percent Change of Urinary Incontinence Frequency From Baseline to 13 Weeks; Percent Change of Excess Voiding Frequency During Waking Hours From Baseline to 13 Weeks; Percent Change of Frequency of Voids Awakening From Sleep From Baseline to 13 Weeks; Percent Change of Frequency of Voids With Urgency From Baseline to 13 Weeks.
Enrollment: 10 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 10 participants or records.
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