Urge Urinary Incontinence
Conditions
Brief summary
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
Interventions
DEVICEAltaviva™ system
Programmable neurostimulation system that delivers electrical stimulation to the tibial nerve for tibial neuromodulation therapy.
Sponsors
MedtronicNeuro
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint | 60 months | 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. |
Countries
United States
Contacts
CONTACTMylene Champs
Outcome results
None listed