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

NCT04232696 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 331

Last updated 2025-11-03

Study results available
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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.

Conditions

  • Urinary Urgency Incontinence

Interventions

DEVICE

Neuspera Implantable Sacral Nerve Stimulation System

Stimulation of the Sacral Nerve.

Sponsors & Collaborators

  • Neuspera Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Osvaldo Padron, MD · Florida Urology Partners

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-13
Primary Completion
2024-07-17
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04232696 on ClinicalTrials.gov