Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device
ConditionUrge Urinary Incontinence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedtronicNeuro
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Altaviva™ system
DeviceProgrammable neurostimulation system that delivers electrical stimulation to the tibial nerve for tibial neuromodulation therapy.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 monthsSponsors and contacts
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Source ClinicalTrials.gov