Altaviva™ Tibial Device for Urge Incontinence

(ENDURANCE™ Trial)

Overseen By Mylene Champs

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MedtronicNeuro

Must be taking: OAB medications

Must not be taking: Botulinum toxin, Sacral neuromodulation

Disqualifiers: Neurological disease, Peripheral neuropathy, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Initial treatment phase duration not specified

256 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

Inclusion Criteria

I am able and willing to follow study instructions and complete all required tasks.

I have been on the same OAB medication dose for at least 3 months and will continue it for 12 months.

I am eligible to receive Altaviva therapy as described in its instructions.

Exclusion Criteria

I have had botox or nerve therapy for urinary symptoms in the last 6 months.

I currently have symptoms of a urinary tract infection.

Primary stress incontinence or mixed incontinence where the stress component overrides the urge component based on physician judgment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Altaviva™ system for the treatment of UUI

Initial treatment phase duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Annual visits

What Are the Treatments Tested in This Trial?

Who Is Running the Clinical Trial?

MedtronicNeuro

Lead Sponsor

Trials

72

Recruited

20,900+

Geoff Martha

MedtronicNeuro

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Eric Peterson

MedtronicNeuro

Chief Medical Officer since 2020

MD from University of Miami