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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 |
12/19/2025
|
| Study Name |
ENDURANCE
|
| 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
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
|
| 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 at approximately 30 sites 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.
|
| Key Study Endpoints |
Endpoints 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.
The following additional effectiveness endpoints will 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),
-Change in general mental health as measured with GHQ-12 overall total score (for 6-month, 12-month and 60-month
visits only)
-Change in sexual matters quality of life as measured with ICIQ-FLUTSsex or ICIQMLUTSsex overall total score (for 6-month, 12-month and 60-month visits only)
-Change in work productivity and activity impairment as measured with the WPAI:SHP (for 6-month, 12-month and 60-month visits only)
-Patient reported impression of improvement as measured with the Patient Global Impression of Improvement (PGI-I) questionnaire,
-Patient satisfaction
-Physician/site staff satisfaction (for implant and 12-month visits only)
-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
|
| Follow-up Visits and Length of Follow-up |
5 years
|
