Urge Urinary IncontinenceENDURANCE™NCT07456865
Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device
A study testing Altaviva™ system in people with Urge Urinary Incontinence, run by MedtronicNeuro at 19 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urge Urinary Incontinence
- What is being tested?
- Altaviva™ system
- Type of treatment
- Medical device
- How many people
- 256 participants
- Where
- 19 sitesUnited States
- Study dates
- 17 Mar 2026to Nov 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
United States19 sites, 19 recruiting
- Recruiting
Institute for Female Pelvic Medicine and Reconstructive Surgery
Allentown, Pennsylvania, 18103
Eileen Taff, 610-402-1800
Vincent Lucente
- Recruiting
UPNT Research Institute
Arlington, Texas, 76017
Amanda Rosenberg, 866-367-8768
Keith Xavier
- Recruiting
Urology Austin
Austin, Texas, 78745
Michelle Valentin-Rivera, 512-410-3773
Elizabeth Mobley
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Louisa Keil, 843-792-5252
Eric Rovner
- Recruiting
TriHealth Hatton Research Institute
Cincinnati, Ohio, 45242
Jennifer Hodge, 513-862-4012
Catrina Crisp
- Recruiting
University Hospitals
Cleveland, Ohio, 44106
Grace Moss, 855-739-0679
Adonis Hijaz
- Recruiting
MetroHealth Medical Center
Cleveland, Ohio, 44109
Erica Ramos, 216-778-7800
Jeffrey Mangel
- Recruiting
Central Ohio Urology Group
Gahanna, Ohio, 43230
Shayna Phillips, 614-396-2684
Jeffrey Carey
- Recruiting
Academic Urology & Urogynecology of Arizona
Glendale, Arizona, 85306
Maria Jimenez, 623-547-2600
Jennifer Klauschie
- Recruiting
Urology Specialists of the Carolinas
Greensboro, North Carolina, 27403
Sherry Barnes, 336-274-1114
Scott MacDiarmid
- Recruiting
Urology Centers of Alabama
Homewood, Alabama, 35209
Kaitlin Williams, 205-930-0920
Alison Pickering
- Recruiting
Rosemark Women Care Specialists
Idaho Falls, Idaho, 83404
Liz Carranza, 208-557-2900
Ty Erickson
- Recruiting
Chesapeake Urology Research Associates
Owings Mills, Maryland, 21117
Seema Shahi, 410-581-1600
Laura Giusto
- Recruiting
Penn Medicine Washington Square
Philadelphia, Pennsylvania, 19107
Hanna Stambakio, 215-316-5151
Ariana Smith
- Recruiting
Sanford Female Pelvic Medicine & Reconstructive Surgery Clinic
Sioux Falls, South Dakota, 57105
Jennifer Pratt, 605-328-8750
Kevin Benson
- Recruiting
Urology Specialists
Sioux Falls, South Dakota, 57108
Alexi Johnson, 605-336-0635
Lauren Wood Thum
- Recruiting
Urology of Saint Louis
St Louis, Missouri, 63141-8657
Jackie King, 314-567-6071
Travis Bullock
- Recruiting
Southern Urogynecology
West Columbia, South Carolina, 29169-3456
Tina McGready, 803-457-7000
Jessica Rueb
- Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27103
Sachin Vyas, 336-716-4131
Candace Parker-Autry
About this study
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
- Conditions
- Urge Urinary Incontinence
- Being tested
- Altaviva™ system
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Altaviva™ systemDevice
Programmable neurostimulation system that delivers electrical stimulation to the tibial nerve for tibial neuromodulation therapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start17 Mar 2026
- Primary completionNov 2032 (estimated)
- Study completionNov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urge Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456865
- Sponsor's protocol ID
- MDT25016
- Acronym
- ENDURANCE™
- Status last verified
- Oct 2026
- First submitted
- 2 Mar 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device
- ClinicalTrials.gov ID
- NCT07456865
- Acronym / sponsor ID
- ENDURANCE™ / MDT25016
- Conditions
- Urge Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- Nov 2032 (estimated)
- Study completion
- Nov 2032 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- Patient who is not a candidate for Altaviva™ therapy per Altaviva™ labeling, including:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Altaviva™ systemProgrammable neurostimulation system that delivers electrical stimulation to the tibial nerve for tibial neuromodulation therapy. | Device | – |
Primary outcome
Primary Endpoint
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Altaviva™ system in people with Urge Urinary Incontinence, run by MedtronicNeuro at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mylene Champs (763-526-1627, mylene.champs@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.