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256 Participants NeededMy employer runs this trial

Altaviva™ Tibial Device for Urge Incontinence

(ENDURANCE™ Trial)

Recruiting at 13 trial locations
MC
Overseen ByMylene 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 GroupAll trial participants will receive the active study treatment (no placebo)

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?

This trial is for adults with urge urinary incontinence who have at least 3 episodes in 72 hours, can use the Altaviva™ device, and are able to follow study instructions. People can't join if they recently had certain bladder treatments, have a current UTI, mainly stress incontinence, are pregnant or planning pregnancy, or aren't good candidates for surgery.

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.
See 2 more

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
See 5 more

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?

Trial Overview

The study is testing the long-term safety and effectiveness of the Altaviva™ tibial nerve stimulation device for treating urge urinary incontinence. Participants will use this system as part of their care and be followed over time.

Find a Clinic Near You

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

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