Recruiting NCT07456865
Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Altaviva™ system.
- Who it may be relevant to
- Registry conditions: Urge Urinary Incontinence. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Device Altaviva™ system
Programmable neurostimulation system that delivers electrical stimulation to the tibial nerve for tibial neuromodulation therapy.
Primary outcome measures
- Primary Endpoint [Time frame: 60 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 10 centers
- Urology Centers of Alabama — Homewood
- Rosemark Women Care Specialists — Idaho Falls
- Urology of Saint Louis — St Louis
- Urology Specialists of the Carolinas — Greensboro
- University Hospitals — Cleveland
- Central Ohio Urology Group — Gahanna
- Institute for Female Pelvic Medicine and Reconstructive Surgery — Allentown
- Southern Urogynecology — West Columbia
- … and 2 more centers
Identifiers
NCT: NCT07456865 · MDT25016