NCT05064384

Axonics SacRal NeuromodulaTIon System RegisTRY Study

Axonics SacRal NeuromodulaTIon System RegisTRY Study : ARTISTRY

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 272 (actual)
• Sponsor: Axonics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the post-market clinical outcomes with use of the Axonics Sacral Neuromodulation System(s).

Detailed description

The study will be a prospective, multi-center, single-arm, post-market registry study. Participant outcomes will be compared to their baseline, with participants serving as their own control. The study is expected to complete enrollment in approximately 24 months and follow the patients per protocol for 1 year. The study was conducted at approximately 30 centers in the United States and Canada.

Conditions

• Urinary Retention
• Urinary Urge Incontinence
• Urgency-Frequency
• Fecal Incontinence

Timeline

• Start date: 2020-11-30
• Primary completion: 2023-10-06
• Completion: 2024-03-31
• First posted: 2021-10-01
• Last updated: 2025-09-22
• Results posted: 2025-06-05

Locations

27 sites across 2 countries: United States, Canada