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Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device

RecruitingNAAges 18 Years - anyAllMedtronicNeuro
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Candidate for Altaviva™ therapy per Altaviva™ labeling 2. 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 3. 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 4. Patient must be willing and able to accurately complete study questionnaires, attend visits, operate the system, and comply with the study protocol 5. Willing and able to provide signed and dated informed consent Exclusion Criteria: 1. 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 2. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component based on physician judgment 3. Current symptomatic urinary tract infection 4. 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 5. Patients who have had treatment of urinary symptoms with botulinum toxin therapy or sacral neuromodulation in the past 6 months 6. History of a prior implantable tibial neuromodulation system 7. Patients who are pregnant or planning to become pregnant during the course of the study 8. Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound study results
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What it tests

  • Altaviva™ system
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Where

19 sites
Urology Centers of Alabama
Homewood, United States
Academic Urology & Urogynecology of Arizona
Glendale, United States
Rosemark Women Care Specialists
Idaho Falls, United States
Chesapeake Urology Research Associates
Owings Mills, United States
Urology of Saint Louis
St Louis, United States
Urology Specialists of the Carolinas
Greensboro, United States
Atrium Health Wake Forest Baptist
Winston-Salem, United States
TriHealth Hatton Research Institute
Cincinnati, United States

…and 11 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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