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

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence, Urge
• Intervention / Treatment: Device: Axonics Sacral Neuromodulation System (SNM) System

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 Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands
    • Maastricht University Medical Center
• United Kingdom
  • London, United Kingdom
    • UCLH
• United States
  • California
    • Irvine, California, United States, 95134
      • UC Irvine Health
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Primary 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Urinary Urgency Incontinence	Device: Axonics Sacral Neuromodulation System (SNM) System; Axonics Sacral Neuromodulation System (SNM) System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Responders	Responders are defined as patients with greater than or equal to 50% reduction in symptoms	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICIQ-OAB-qol	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.	2 years
Daily Number of Urgency Leaks	The daily number of urgency leaks is measured by a bladder diary	2 years
Voids	Measured by a bladder diary	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CCF-FIS Score for Participants With a CCF-FIS Score ≥6 at Baseline	Change in CCF-FIS score at follow-up compared to baseline. Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): includes 5 items (solid, liquid, gas, wears pad and lifestyle alteration) and 5 frequencies (never = 0, rarely = 1, sometimes = 2, usually = 3, always = 4). Scores range from 0 for full continence to 20 for complete incontinence. A higher score indicates more severe FI symptoms and a score ≥ 6 indicates moderate to severe FI symptoms.	Baseline, 2-years
Participant Satisfaction for Treatment of UUI Symptoms	The subject satisfaction questionnaire was designed to provide information on subjective satisfaction with r-SNM therapy and the recharging experience. Participants indicated satisfaction with r-SNM therapy for treatment of their UUI symptoms based on a 7-point Likert scale ranging from "Very satisfied" to "Very dissatisfied". Results are presented as the number of participants who reported "Very, moderately, or slightly satisfied" with r-SNM therapy for treatment of their UUI symptoms.	2-year

Collaborators and Investigators

• Sponsor: Axonics, Inc.
• Investigators: Principal Investigator: Howard Goldman, MD FACS, The Cleveland Clinic; Principal Investigator: Felicia Lane, MD, UC Irvine Health

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2017
• Primary Completion (Actual): January 18, 2019
• Study Completion (Actual): June 29, 2020

Study Registration Dates

• First Submitted: October 27, 2017
• First Submitted That Met QC Criteria: October 27, 2017
• First Posted (Actual): November 1, 2017

Study Record Updates

• Last Update Posted (Estimated): October 24, 2025
• Last Update Submitted That Met QC Criteria: October 10, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: SNM; Sacral neuromodulation (SNM)
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Urge; Therapeutics; Drug Therapy; Drug Delivery Systems
• Other Study ID Numbers: 105-0050

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes