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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P240011 / PAS001 |
| Date Original Protocol Accepted |
09/18/2025
|
| Date Current Protocol Accepted |
09/18/2025
|
| Study Name |
TITAN 2 Pivotal Study
|
| Device Name |
Medtronic Altaviva System
|
| Clinical Trial Number(s) |
NCT05226286
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| 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 yrs < 22 yrs,
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This study was initiated prior to device approval and is a single-arm, multi-center clinical study. It was conducted at 25 sites and enrolled 188 subjects. One hundred and twenty-six (126) subjects were implanted in this study. The 12-month outcomes from the study were used to support PMA approval. The 24-months follow-up data from this study must be submitted to assess the continued safety and effectiveness of the Medtronic Altaviva System.
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| Study Population |
Male and Female patients with urge urinary incontinence (UUI)
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| Sample Size |
188 subjects were enrolled, and 126 subjects were implanted
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| Key Study Endpoints |
Effectiveness
• Percentage of subjects who experience an improvement in UUI episodes (therapy responders) of at least 50% or more (primary)
• Percentage of subjects who experience an improvement in OAB-q HRQL of at least 10 points.
• Change from baseline in quality of life as measured and assessed by the total OAB-q HRQL (health related quality of life) score
• Change from baseline in mean number of UUI episodes
• Subgroup analysis of the UUI responder rate for the patient population 65 and older.
Safety
• Comprehensive summary of all adverse events (AEs) for the duration of study participation, including all device- or procedure-related AEs and device-, procedure-related serious adverse events.
• Revision rates
• Explantation rates
Device Use
¿ Device parameters including but not limited to voltage, pulse width, frequency, and stimulation duration/day
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| Follow-up Visits and Length of Follow-up |
24-months follow-up of the pivotal study
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
188
|
| Actual Number of Sites Enrolled |
29
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| Patient Follow-up Rate |
55.3% (104/188) through 24 months
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| Final Safety Findings |
Of the 188 subjects enrolled, a total of 126 subjects were implanted during this study. 718 total adverse events (AEs) were reported in 188 subjects from enrollment through study completion (24 months). Following implantation, there were 226 AEs in 71% (90/126) of subjects through 6 months, 439 AEs in 85% (107/126) of subjects through 12 months, and 685 AEs in 91% (115/126) of implanted subjects through 24 months. Device and Procedure-related AEs were reported in 17% (21/126) of subjects at 6 months, 20% (25/126) at 12 months, and 24% (30/126) through study end, with the highest incidence occurring in the first 3 months post-implant. The most common device and procedure-related AEs were implant site infection (4%, 5/126) and device-related pain (4%, 5/126). Two device or procedure related serious adverse events (SAEs) were reported throughout the entire study period (Clostridium difficile colitis, implant wound infection resulting in device explant). All device and procedure-related AEs were classified as mild (grade 1, 9% (11/126) of subjects) or moderate (grade 2, 18% (23/126) of subjects). More severe events (grades 3-5) occurred in 38% (48/126) of subjects but were not device related. Through 24 months, 3 subjects required system modifications due to device and procedure-related AEs, with 18 total explanations performed primarily at the patient’s request.
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| Final Effect Findings |
The urge urinary incontinence (UUI) responder (i.e., more than 50% improvement in daily UUI episodes as compared to baseline) rates decreased from 58.4% (73.5/126) at 6 months to 55.5% (70/126) at 24 months in the 'all implanted' analysis set (N=126). The average change in UUI episodes/day from baseline was 2.7 at 6 and 12 months and 2.6 at 24 months. Results from the Overactive Bladder Questionnaire (OAB-q) scores were overall stable with the average score being 71.1 at 12 months and 72.7 in 24 months The OAB-q responder (i.e., an improvement in OAB-q score of at least 10 points) rate at 24 months decreased to 59% (74/126) from 65.1% (82/126) at 12 months and 70.6% (89/126) at 6 months follow-up. Effectiveness differences were observed between age-related subgroups. At 24 months, patients over 65 years old showed 49% (33.3/68) UUI response rates compared to 63.2% (36.6/58) in younger patients. Additionally, the stimulation amplitude increased over time. The average value of the stimulation amplitude increased from 5.5 mA at 1 month to 8.4 mA at 24 months.
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| Study Strengths & Weaknesses |
Strengths:
Prospective, multicenter clinical study.
High rate of follow-up at 24 months (104 of 126 (82.5%) implanted subjects completed 24 month followed up).
Weaknesses:
Single-arm study, therefore, in the absence of a control group, the study endpoints may be subject to placebo effect.
Given the UUI responder rate over time and effectiveness differences in subjects >65 years old, longer-term effectiveness data are necessary to determine whether the device’s effectiveness continues to diminish over time and with age.
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| Recommendations for Labeling Changes |
The sponsor should revise the labeling to include the 24-month data from the pivotal study in the labeling.
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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)
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| 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.
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| 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
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| Follow-up Visits and Length of Follow-up |
5 years
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