Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device

Part of paid clinical trials in Homewood, Alabama.

Sponsor
MedtronicNeuro
Study ID
NCT07456865
Status
Recruiting
Apply to this trial

Conditions

  • Urge Urinary Incontinence

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Altaviva™ system — DEVICE
    Programmable neurostimulation system that delivers electrical stimulation to the tibial nerve for tibial neuromodulation therapy.

Study Details

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

Key Dates

Start date
Mar 17, 2026
Status verified
Jun 2026
Primary completion
Nov 30, 2032
Completion
Nov 30, 2032

Study Design

Enrollment
256 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Primary Endpoint [ Time Frame: 60 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Urology Centers of AlabamaHomewoodAlabama35209
Kaitlin Williams
205-930-0920
Alison Pickering (PRINCIPAL_INVESTIGATOR)
Urology of Saint LouisSt LouisMissouri63141-8657
Mejra Dzinic
314-567-6071
Travis Bullock (PRINCIPAL_INVESTIGATOR)
Institute for Female Pelvic Medicine and Reconstructive SurgeryAllentownPennsylvania18103
Eileen Taff
610-402-1800
Vincent Lucente (PRINCIPAL_INVESTIGATOR)
Southern UrogynecologyWest ColumbiaSouth Carolina29169-3456
Tina McGready
803-457-7000
Jessica Rueb (PRINCIPAL_INVESTIGATOR)
Urology SpecialistsSioux FallsSouth Dakota57108
Alexi Johnson
605-336-0635
Lauren Wood Thum (PRINCIPAL_INVESTIGATOR)

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Urology Centers of Alabama· Homewood, ALUrology of Saint Louis· St Louis, MOInstitute for Female Pelvic Medicine and Reconstructive Surgery· Allentown, PASouthern Urogynecology· West Columbia, SCUrology Specialists· Sioux Falls, SD

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