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

Axonics

Status: Completed

Conditions: Urinary Incontinence, Urge

Treatments: Device: Axonics Sacral Neuromodulation System (SNM) System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03327948

105-0050

Details and patient eligibility

About

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.

Full 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

Enrollment: 129 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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129 participants in 1 patient group

Treatment group

Experimental group

Description:

Urinary Urgency Incontinence

Treatment:

Device: Axonics Sacral Neuromodulation System (SNM) System