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NCT04232696 · ClinicalTrials.gov registry record · NA
Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
A NA study of Urinary Urgency Incontinence, sponsored by Neuspera Medical.
- Active
- Registry status
- NA
- Development phase
- 331
- Enrollment target
- 20
- Study locations
NCT04232696: Active NA study of Urinary Urgency Incontinence, sponsored by Neuspera Medical.
NCT04232696 is a NA study of Urinary Urgency Incontinence that is active but no longer recruiting, run by Neuspera Medical. The registered enrollment target is 331 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04232696, a NA study of Urinary Urgency Incontinence, is active but no longer recruiting, sponsored by Neuspera Medical.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 331 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Change in Urinary Urgency Incontinence episodes at six months, relative to the number of Urinary Urgency Incontinence episodes at baseline.
Conditions Studied
Interventions
- DEVICE Neuspera Implantable Sacral Nerve Stimulation System
Study Locations (20)
California
- Genesis Healthcare Partners - Encinitas
- Kaiser Permanente, LAMC - Los Angeles
- Kaiser Permanente - San Diego
Florida
- Clinical Research Center of Florida - Pompano Beach
- Florida Urology Partners, LLC - Tampa
Georgia
- Midtown Urology - Atlanta
- Meridian Clinical Research - Savannah
Indiana
- Women's Health Advantage - Fort Wayne
- Indiana University School of Medicine - Indianapolis
Minnesota
- University of Minnesota - Minneapolis
- Minnesota Urology - Woodbury
New York
- Weill Cornell Medical College - New York
- Premier Medical Group - Poughkeepsie
Illinois
- Comprehensive Urologic Care - Lake Barrington
Kansas
- University of Kansas Hospital - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 331 participants |
| Start Date | 2019-12-13 |
| Est. Completion | 2026-12 |
| Phase | NA |
What the registry record for NCT04232696 still lists
NCT04232696 is an interventional study that assigns participants to a tested intervention. The registered 331 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Urinary Urgency Incontinence appearing as the primary indexed condition, and to 1 intervention - of which Neuspera Implantable Sacral Nerve Stimulation System is the first listed.
NCT04232696 names 20 study sites across 13 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT04232696 about?
NCT04232696 is a clinical study titled "Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)". 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 Sac...
What is the current status of trial NCT04232696?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 331 participants. The study started on 2019-12-13. Estimated completion is 2026-12.
What conditions does trial NCT04232696 study?
This clinical trial studies the following conditions: Urinary Urgency Incontinence.
What interventions are being tested in trial NCT04232696?
The interventions under investigation include: Neuspera Implantable Sacral Nerve Stimulation System (DEVICE).
Who is sponsoring clinical trial NCT04232696?
This trial is sponsored by Neuspera Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04232696 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04232696's enrollment target sits among peer trials
331 307th of 2000 higher than 1,694 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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