An interventional study of Altaviva™ system in Urge Urinary Incontinence, sponsored by MedtronicNeuro. Recruiting at 19 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by MedtronicNeuro (part of Medtronic) · Not applicable, Interventional, and Treatment
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
242 studies on the registry are indexed under Urinary Incontinence, Urge; 39 are open to participants now.
This study's planned enrollment of 256 is above the median of 86 across 190 interventional studies indexed under Urinary Incontinence, Urge.
Browse Urinary Incontinence, Urge studies →MedtronicNeuro is the lead sponsor of 74 studies on the registry; 2 are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patient who is not a candidate for Altaviva™ therapy per Altaviva™ labeling, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Programmable neurostimulation system that delivers electrical stimulation to the tibial nerve for tibial neuromodulation therapy.
Primary Endpoint
The primary endpoint is the UUI responder rate, which is defined as the proportion of subjects experiencing at least 50% improvement in daily UUI compared to baseline. The UUI responder rate will be measured annually through 60 months.
Time frame: 60 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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