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

Neuspera's Implantable Sacral Nerve Stimulation (SNS) System is indicated to treat participants with UUI who have failed or could not tolerate more conservative treatments. The study will be conducted in two phases: Phase I of the study will be conducted at up to 9 clinical study sites in the US and Europe. Phase II of the study will be conducted in up to 35 clinical sites in the US and Europe, inclusive of the Phase I centers. Prospective, multi-center, single-arm, seamless phase-pivotal study. 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. All participants will receive the same length of device stimulation as determined in Phase I testing. Phase I will enroll up to 55 participants. Phase II will enroll up to 255 participants.