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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P240031 / PAS001 |
| Date Original Protocol Accepted |
08/15/2025
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| Date Current Protocol Accepted |
08/15/2025
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| Study Name |
PAS of the Neuspera SNM in Patients with UUI
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| Device Name |
Neuspera Sacral Neuromodulation System
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| Clinical Trial Number(s) |
NCT04232696
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of the PAS is to assess the long-term safety and effectiveness of the Neuspera SNM System (assessed annually through 72 months post-implant) following commercial approval of the Neuspera SNM System.
This is a prospective, multi-center, single-arm, post-approval study using the Neuspera SNM System for treatment of urge urinary incontinence (UUI) in subjects who have failed or could not tolerate more conservative treatment.
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| Study Population |
Study population will include all Phase I and Phase II subjects from the SANS-UUI pivotal clinical study who sign the PAS informed consent form.
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| Sample Size |
Number of subjects: up to 116 subjects (at least 93 subjects)
At least 80% of the SANS-UUI cohort must be followed out to 72 months post procedure.
Number of sites: 21 sites( The PAS will be conducted at the SANS-UUI Phase I and II study sites.)
Site location: U.S. and Europe
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| Key Study Endpoints |
Safety Endpoints
Primary: The primary safety endpoint is defined as the incidence of device- and procedure-related AEs. The analysis of the endpoint is the proportion of subjects experiencing a device- and/or procedure-related AE at yearly intervals through the 72-month post-implant.
Secondary:
- Comprehensive summary of all adverse events (AEs) for the duration of study participation, including all device- or procedure-related adverse events, including but not limited to, burns, erosions, implant migrations and fractures, explantations, and revisions
- The percentage of subjects with device-related serious adverse events reported
- Device fracture and migration rates*
- Revision rates*
- Explantation rates*
*The device fractures and migration rates, revision rates, and explantation rates will be reported to FDA annually post commercial approval through the 72-month timepoint. The report will include a detailed report of fractures and migrations, including when it occurred, any cause of fracture/migration that was noted and how it was measured, and how the issue was resolved.
Effectiveness Endpoints
Primary: The primary effectiveness endpoint is defined as the percentage of all implanted subjects who experience an improvement in UUI episodes of at least 50% or more (therapy responders) at yearly intervals through 72-month post-implant. A therapy responder is defined as experiencing =50% reduction in the number of UUI episodes, relative to the number of UUI episodes at baseline.
Secondary:
- Change from baseline in quality of life as measured and assessed by the total ICIQ-OABqol score
- Change from baseline in mean number of UUI episodes
- The percentage of subjects who experience an improvement in ICIQ-OABqol of at least 10 points
- Change in urgent voids per day calculated across all diary episodes with at least mild urgency
- Change in average number of daily voids from baseline in subjects with at least 8 voids at baseline
- Change in quality of life measured from baseline as measured and assessed by the ICIQ-OABqol subscale scores
- Change in Male/Female Lower Urinary Tract Symptoms questionnaire
- Patient Global Impression of Improvement (PGI-I) measured after implant during follow-up
- Device parameters including but not limited to voltage, pulse width, frequency, and stimulating electrode
Patient compliance with therapy at every 6-month visit, as measured by the number of stimulation hours per day for seven (7) days immediately prior to the telephone reminder call and by actual use data (including the stimulation daily use and duration of time) collected in the WT log and patient app.
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| Follow-up Visits and Length of Follow-up |
Frequency of Follow-up Visits and Length of Follow-up SANS-UUI subjects will be enrolled in the PAS within 3 months of FDA marketing approval of the Neuspera SNM System. Subject follow-up visits will start with the next visit following their last completed SANS-UUI study visit; for example, if their last visit in the SANS-UUI study was at 18 months, their first PAS follow-up visit will be at 24 months post-implant.
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