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

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Results first posted: Nov 3, 2025
    • Primary endpoints revised (2)
    • Enrollment target: 242 to 331
    v20
  2. Primary endpoints revised (2)v19
  3. Secondary endpoints revised (12)
    • Primary endpoints revised (2)
    v18
  4. Study sites: 29 to 34v17
  5. Study Identification, Study Status, Oversightv16
Show 14 earlier versionsHide 14 earlier versions
  1. Primary completion date changed from estimate of Jul 2024 to Jul 17, 2024v15
  2. Primary completion date: Oct 2023 to Jul 2024v14 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 310 to confirmed 242
    • Study sites: 34 to 29
    • Study completion date: Apr 2024 to Dec 2026
    • Study description revised
  3. Study sites: 32 to 34
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: 11 to 12
    v13
  4. Study sites: 17 to 32v12
  5. Primary completion date: Oct 2022 to Oct 2023
    • Study sites: 10 to 17
    • Study completion date: Dec 2023 to Apr 2024
    • Study title expanded, about 2 words
    v11
  6. Enrollment target: 210 to 310v10 Show 6 more changesShow less
    • Primary completion date: Jul 2022 to Oct 2022
    • Study completion date: Sep 2023 to Dec 2023
    • Eligibility criteria shortened, about 14 words
    • Secondary endpoints: 12 to 11
    • Site details revised at 6 of 10 sites
    • Study description expanded, about 2 words
  7. Study sites: 6 to 10v9
  8. Site contacts updated at 6 of 6 sitesv8
  9. Site details revised at 1 of 6 sitesv7
  10. Site details revised at 1 of 6 sitesv6
  11. Site details revised at 3 of 6 sitesv5
  12. Study sites: 2 to 6v4
  13. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2020 to Dec 13, 2019
    • Site details revised at 2 of 2 sites
    v3
  14. Secondary endpoints revised (12)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04232696
Lead Sponsor Neuspera Medical, Inc.
Conditions
(from sponsor)		 Urinary Urgency Incontinence
Enrollment 331 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov