NCT03327948

Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt

Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt (ARTISAN-SNM)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Axonics, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The ARTISAN-SNM study is designed to evaluate the safety and effectiveness of the Axonics Sacral Neuromodulation System as an aid in the treatment of the symptoms of urinary urgency incontinence (UUI) in patients who have failed or could not tolerate more conservative treatments.

Detailed description

The ARTISAN-SNM Trial which was a single-arm, prospective study that included 29 centers and enrolled 129 participants. The primary aim of the study was to evaluate the safety and efficacy of the Axonics SNM System for the treatment of UUI symptoms. Primary outcome was improvement in UUI episodes on a 3-day bladder diary. Secondary outcomes included quality of life using the ICIQ-OABqol questionnaire, patient satisfaction, and bowel symptoms captured using the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FIS). Participants were followed out to 2 years and data was reported at 6 months, 1 year and 2 years

Conditions

• Urinary Incontinence, Urge

Interventions

Type	Name	Description
DEVICE	Axonics Sacral Neuromodulation System (SNM) System	Axonics Sacral Neuromodulation System (SNM) System

Timeline

• Start date: 2017-11-21
• Primary completion: 2019-01-18
• Completion: 2020-06-29
• First posted: 2017-11-01
• Last updated: 2025-10-24
• Results posted: 2024-09-03

Locations

4 sites across 3 countries: United States, Netherlands, United Kingdom

Regulatory

• FDA-regulated device study