Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt

Not Applicable

Completed

• Conditions: Urinary Incontinence, Urge

• Registration Number: NCT03327948
• Lead Sponsor: Axonics, Inc.

Brief 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

Study Timeline

• Study First Submitted: 2017-10-27
• Study First Submitted QC: 2017-10-27
• Study First Posted: 2017-11-01
• Study Start: 2017-11-21
• Primary Completion: 2019-01-18
• Study Completion: 2020-06-29
• Results First Submitted: 2022-02-03
• Results First Submitted QC: 2024-08-29
• Results First Posted: 2024-09-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

1. Diagnosis of UUI demonstrated on a 72-hour voiding diary defined as a minimum of four (4) leaking episodes associated with urgency, at least 50% of all leaking episodes associated with urgency, and at least one leaking episode each 24-hour period.
2. Greater than or equal to 6 months' history of UUI diagnosis
3. For male subjects only: Peak flow rate > 15 cc/s as verified by uroflowmetry within 6 months prior to enrollment; Residual bladder volume < 150 cc tested within 6 months prior to enrollment
4. 21 years of age and older
5. Willing and capable of providing informed consent
6. Capable of participating in all testing associated with this clinical investigation

Primary

Exclusion Criteria

1. Stress incontinence or mixed incontinence.
2. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
3. Interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines
4. A female who is breastfeeding
5. A female with a positive urine pregnancy test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of Responders	2 years	Responders are defined as patients with greater than or equal to 50% reduction in symptoms

Secondary Outcome Measures

Name	Time	Method
ICIQ-OAB-qol	2 years	International Consultation on Incontinence Modular Questionnaire (ICIQ)- Overactive Bladder (OAB), Quality of Life (qol). Score range of 0-100, with greater values indicating better quality of life.
Daily Number of Urgency Leaks	2 years	The daily number of urgency leaks is measured by a bladder diary
Voids	2 years	Measured by a bladder diary

Trial Locations

Locations (4)

UC Irvine Health; 🇺🇸 Irvine, California, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands

UCLH; 🇬🇧 London, United Kingdom