Clinical Trial

Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)

Active, Not Recruiting
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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.
Protocol Amendment History 19 amendments
This ClinicalTrials.gov record has been amended 19 times since 2020-01-14; most recent amendment 2025-10-09.
Status change: Recruiting → Active, Not Recruiting 2024-03-12
Status change: Not Yet Recruiting → Recruiting 2020-02-11
Trial Details
NCT Number NCT04232696
Lead Sponsor Neuspera Medical, Inc.
Conditions Urinary Urgency Incontinence
Enrollment 331 participants
Start Date 2019-12-13
Primary Completion 2024-07-17 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-11-03