Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt

NCT ID: NCT03327948

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-21
• Study Completion Date: 2020-06-29

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

Conditions

Urinary Incontinence, Urge

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

Urinary Urgency Incontinence

Group Type: EXPERIMENTAL

Axonics Sacral Neuromodulation System (SNM) System

Intervention Type: DEVICE

Axonics Sacral Neuromodulation System (SNM) System

Interventions

Axonics Sacral Neuromodulation System (SNM) System

Axonics Sacral Neuromodulation System (SNM) System

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Axonics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Howard Goldman, MD FACS

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Felicia Lane, MD

Role: PRINCIPAL_INVESTIGATOR

UC Irvine Health

Locations

UC Irvine Health

Irvine, California, United States

Cleveland Clinic

Cleveland, Ohio, United States

Maastricht University Medical Center

Maastricht, , Netherlands

UCLH

London, , United Kingdom

Countries

United States; Netherlands; United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

105-0050

Identifier Type: -

Identifier Source: org_study_id