NCT07456865 · MedtronicNeuro
Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device
(ENDURANCE™)
What this study is about
The purpose of this forward-looking, conducted at multiple hospitals study is to assess the long-term safety and effectiveness of the Altaviva™ system for the treatment of UUI
View original scientific description
The purpose of this prospective, multicenter study is to assess the long-term safety and effectiveness of the Altaviva™ system for the treatment of UUI
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Candidate for Altaviva™ therapy per Altaviva™ labeling
- Have a diagnosis of UUI as demonstrated on a 3-day voiding diary by having a minimum of 3 episodes of urinary urge incontinence in 72 hours
- If taking OAB medications, subjects should be on a stable dose for at least 3 months prior to baseline and willing to remain on stable treatment through completion of the 12-month voiding diary
- Patient must be willing and able to accurately complete study questionnaires, attend visits, operate the system, and comply with the study protocol
- Willing and able to provide signed and dated informed consent
Exclusion criteria
- Patient who is not a candidate for Altaviva™ therapy per Altaviva™ labeling, including:
- Patients who are considered to be poor surgical candidates or who are at risk for poor wound healing per Altaviva™ labeling
- Have progressive, systemic neurological disease
- Have clinically significant peripheral neuropathy in the lower leg
- Severe, uncontrolled diabetes
- Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component based on physician judgment
- Current symptomatic urinary tract infection
- Patients who have been treated with percutaneous tibial nerve stimulation (PTNS)/percutaneous tibial neuromodulation (PTNM) therapy in the past 4 weeks, or longer if the investigator judges that the therapeutic effect is still present
- Patients who have had treatment of urinary symptoms with botulinum toxin therapy or sacral neuromodulation in the past 6 months
- History of a prior implantable tibial neuromodulation system
- Patients who are pregnant or planning to become pregnant during the course of the study
- Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound study results
Where
- Homewood, Alabama
- Idaho Falls, Idaho
- St Louis, Missouri
- Cleveland, Ohio
- Gahanna, Ohio
- Allentown, Pennsylvania
- West Columbia, South Carolina
- Sioux Falls, South Dakota
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations