At a glance
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Clinical Study of Neuspera's Implantable Sacral Nerve Stimulation (SNS) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
In Brief
A clinical study evaluating Neuspera Implantable Sacral Nerve Stimulation System for Urinary Urgency Incontinence. Active but no longer recruiting, targeting 331 participants across 34 sites in 3 countries.
Detailed Summary
Prospective, multi-center, single-arm, seamless phase-pivotal study conducted in participants diagnosed with UUI who have failed or could not tolerate more conservative treatment. The trial will be conducted in two phases. Objective of Phase I: To assess the utilization of the system during the Sacral Nerve Stimulation (SNS) trial period and to help inform the length of hours of daily stimulation to be used in Phase II of the trial. Objective of Phase II: To assess the safety and efficacy of the Neuspera SNS System at 6-months for the primary efficacy endpoint and at 12 months for secondary safety and efficacy endpoints.
Study Details
Timeline
Interventions
Stimulation of the Sacral Nerve.