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

MedtronicNeuro · NCT07456865

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
256
US sites recruiting
19
Study start
March 17, 2026
Record last updated
October 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: Altaviva™ system

Conditions: Urge Urinary Incontinence

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Urology Centers of Alabama

    Homewood, AL 35209

    Site contact: Kaitlin Williams · 205-930-0920

  • Academic Urology & Urogynecology of Arizona

    Glendale, AZ 85306

    Site contact: Maria Jimenez · 623-547-2600

  • Rosemark Women Care Specialists

    Idaho Falls, ID 83404

    Site contact: Liz Carranza · 208-557-2900

  • Chesapeake Urology Research Associates

    Owings Mills, MD 21117

    Site contact: Seema Shahi · 410-581-1600

  • Urology of Saint Louis

    St Louis, MO 63141-8657

    Site contact: Jackie King · 314-567-6071

  • Urology Specialists of the Carolinas

    Greensboro, NC 27403

    Site contact: Sherry Barnes · 336-274-1114

  • Atrium Health Wake Forest Baptist

    Winston-Salem, NC 27103

    Site contact: Sachin Vyas · 336-716-4131

  • TriHealth Hatton Research Institute

    Cincinnati, OH 45242

    Site contact: Jennifer Hodge · 513-862-4012

  • University Hospitals

    Cleveland, OH 44106

    Site contact: Grace Moss · 855-739-0679

  • MetroHealth Medical Center

    Cleveland, OH 44109

    Site contact: Erica Ramos · 216-778-7800

  • Central Ohio Urology Group

    Gahanna, OH 43230

    Site contact: Shayna Phillips · 614-396-2684

  • Institute for Female Pelvic Medicine and Reconstructive Surgery

    Allentown, PA 18103

    Site contact: Eileen Taff · 610-402-1800

  • Penn Medicine Washington Square

    Philadelphia, PA 19107

    Site contact: Hanna Stambakio · 215-316-5151

  • Medical University of South Carolina

    Charleston, SC 29425

    Site contact: Louisa Keil · 843-792-5252

  • Southern Urogynecology

    West Columbia, SC 29169-3456

    Site contact: Tina McGready · 803-457-7000

  • Sanford Female Pelvic Medicine & Reconstructive Surgery Clinic

    Sioux Falls, SD 57105

    Site contact: Jennifer Pratt · 605-328-8750

  • Urology Specialists

    Sioux Falls, SD 57108

    Site contact: Alexi Johnson · 605-336-0635

  • UPNT Research Institute

    Arlington, TX 76017

    Site contact: Amanda Rosenberg · 866-367-8768

  • Urology Austin

    Austin, TX 78745

    Site contact: Michelle Valentin-Rivera · 512-410-3773

Study contacts (from the official record)

  • Mylene Champs · 763-526-1627 · mylene.champs@medtronic.com
Post Approval Effectiveness and Durability Evaluation of the… (NCT07456865) | Bored Studies