NCT04232696

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: Neuspera Medical, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Urinary Urgency Incontinence

Interventions

Type	Name	Description
DEVICE	Neuspera Implantable Sacral Nerve Stimulation System	Stimulation of the Sacral Nerve.

Timeline

• Start date: 2019-12-13
• Primary completion: 2024-07-17
• Completion: 2026-12-01
• First posted: 2020-01-18
• Last updated: 2025-11-03
• Results posted: 2025-11-03

Locations

34 sites across 3 countries: United States, Belgium, Netherlands

Regulatory

• FDA-regulated device study