Long-term safety and durability of the Altaviva tibial device for urge urinary incontinence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter post‑approval study enrolling adults treated with the Altaviva tibial nerve system to track long‑term safety and effectiveness. Participants must demonstrate urge urinary incontinence on a 3‑day voiding diary and, if on overactive bladder medications, remain on a stable dose. Outcomes include device safety, durability of symptom reduction, and patient‑reported questionnaires with at least a 12‑month voiding diary follow‑up. The study is conducted at multiple U.S. urology and urogynecology centers using standardized device procedures and follow‑up assessments.

Why it matters

Who can join: the full rules

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

Where it's running

• Urology Centers of Alabama
  Homewood, Alabama, United States Recruiting
• Academic Urology & Urogynecology of Arizona
  Glendale, Arizona, United States Recruiting
• Rosemark Women Care Specialists
  Idaho Falls, Idaho, United States Recruiting
• Chesapeake Urology Research Associates
  Owings Mills, Maryland, United States Recruiting
• Urology of Saint Louis
  St Louis, Missouri, United States Recruiting
• Urology Specialists of the Carolinas
  Greensboro, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Mylene Champs
• Email: mylene.champs@medtronic.com
• Phone: 763-526-1627

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Vaginal radiofrequency treatment targeting bladder nerves for overactive bladder in women

  This trial will test whether a single vaginal radiofrequency treatment with the MORPHEUSV device can reduce urgency-related urine leaks in adult women with overactive bladder.

  Recruiting at 5 sites InMode MD Ltd. · Palo Alto, California and 8 other locations · NCT07209397

• Personalized pudendal nerve stimulation for mixed urinary incontinence and pelvic pain

  This trial will try personalized pudendal nerve stimulation with an implanted Picostim II device to reduce leakage and pelvic pain in adult women with mixed urinary incontinence who haven't improved with conservative treatments.

  Recruiting at 6 sites Amber Therapeutics Ltd · Leuven, Herestraat 49 and 6 other locations · NCT06885931

• Combining neuromodulation and exercise for treating urinary incontinence

  This study is testing if combining special exercises with nerve stimulation can help menopausal women with urge urinary incontinence and overactive bladder feel better.

  Recruiting Fundación Universidad Católica de Valencia San Vicente Mártir · Valencia, Valencia · NCT06783374

• Evaluating a new device for treating overactive bladder and bowel dysfunction

  This study is testing a new device that uses electrical stimulation to see if it can help people with overactive bladder and bowel issues feel better.

  Recruiting at 3 sites InnoCon Medical · Aarhus and 2 other locations · NCT06754189

• Using high-dose vitamin D to treat overactive bladder in children

  This study is testing if giving high-dose vitamin D along with regular therapy can help children with wet overactive bladder feel better compared to just therapy or therapy with a medication.

  Recruiting Children's Hospital of Chongqing Medical University · Chongqing, Chongqing Municipality · NCT06201013

• Treatment of Overactive Bladder and Bowel Dysfunction with UCon Bar Electrode

  This study is testing a new device to see if it can help women with overactive bladder and bowel issues feel better by using electrical stimulation.

  Recruiting at 3 sites InnoCon Medical · Aarhus and 2 other locations · NCT06091566

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.