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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P240011 / PAS002 |
| Date Original Protocol Accepted |
09/18/2025
|
| Date Current Protocol Accepted |
09/18/2025
|
| Study Name |
Tibial Neuromodulation (TNM) PAS
|
| Device Name |
Medtronic Altaviva System
|
| Clinical Trial Number(s) |
NCT05226286
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The primary purpose of this prospective, multicenter study is to assess the long-term safety and effectiveness of the Altaviva system for the treatment of UUI.
|
| Study Population |
Male and Female patients with urge urinary incontinence (UUI)
|
| Sample Size |
Approximately 256 subjects will be enrolled in the study to achieve a minimum of 170 implanted subjects to account for about 33% attrition between enrollment and implant. At least 90 subjects must be followed to 60 months post implant. Additionally, a least 50% of enrolled subjects must be aged 65 years or older. To ensure that a minimum of 50% of enrolled subjects are aged 65 years or older, enrollment may be opened exclusively to individuals within this age group during the study if needed.
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| Key Study Endpoints |
o Primary Effectiveness Endpoint: UUI responder rate annually through 60 months after implant. A UUI responder is defined as having at least 50% improvement from baseline in daily UUI episodes.
o Additional Effectiveness Endpoints:
– The following endpoints should be evaluated annually through 60 months:
¿ Change from baseline in daily UUI episodes
¿ UUI responder rate for subjects aged 65 and older
¿ Change in OAB-q HRQL
¿ Other urinary symptoms as measured with voiding diaries
• Change from baseline in daily urinary frequency (UF) episodes in subjects with UF at baseline
• Change in daily urgent episodes
• Change in urinary urgency based on the Indevus Urgency Severity Scale (IUSS)
• Complete continence rate
• Change in nocturia rate
¿ Change in urinary urgency as measured with the Urgency Perception Scale (UPS)
¿ Patient reported impression of improvement as measured with the Patient Global Impression of Improvement (PGI-I) questionnaire
¿ Device and system usage data
Safety Endpoints:
¿ Procedure-, device-, and/or therapy-related adverse events through 60 months by reporting the number of events, and number and percentage of subjects with events.
¿ Serious adverse events through 60 months by reporting the number of events, and number and percentage of subjects with events
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| Follow-up Visits and Length of Follow-up |
5 years
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