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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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TITAN 2 Pivotal Study


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General
Study Status Study Pending
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 
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) : 18-21 yrs, Adult: >21
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.
Study Population Male and Female patients with urge urinary incontinence (UUI)
Sample Size 188 subjects were enrolled, and 126 subjects were implanted
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
Follow-up Visits and Length of Follow-up 24-months follow-up of the pivotal study


TITAN 2 Pivotal Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
final report 11/17/2025 11/26/2025 Overdue/Received


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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