Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt

Study Overview
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Brief Summary
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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.

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

Conditions
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Urinary Incontinence, Urge

Intervention / Treatment
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* Device: Axonics Sacral Neuromodulation System (SNM) System


Participation Criteria
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Eligibility Criteria
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Primary Inclusion Criteria: 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. Greater than or equal to 6 months' history of UUI diagnosis 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 21 years of age and older Willing and capable of providing informed consent Capable of participating in all testing associated with this clinical investigation Primary Exclusion Criteria: Stress incontinence or mixed incontinence. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture) Interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines A female who is breastfeeding A female with a positive urine pregnancy test

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Urinary Urgency Incontinence | Device: Axonics Sacral Neuromodulation System (SNM) System<br>* Axonics Sacral Neuromodulation System (SNM) System<br>|

What is the study measuring?
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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 | 6 month | 

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. | 6 month | 
| Number of leaks |  | 6 month | 
| Number of voids |  | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sacral neuromodulation (SNM), SNM