Cycling Study With the Axonics System

Study Overview
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Brief Summary
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A prospective, multi-center, study comparing continuous sacral neuromodulation (SNM) stimulation to daily cyclic stimulation of 2 hours on and 22 hours off using the Axonics System.

Detailed Description
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After consent is provided, the required visits are at Baseline, Day 0, 1-Month, and 3-Month. At the follow-up visits, a bladder diary is reviewed, symptoms are assessed, the PGI-I questionnaire is completed, and cyclic stimulation hours may be changed.

Official Title
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Cycling Study With the Axonics System

Conditions
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Overactive Bladder Syndrome, Urinary Urge Incontinence, Sacral Neuromodulation

Intervention / Treatment
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* Device: Axonics System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who are ≥ 21 years at the time of consent Has a primary indication of UUI (participants with a secondary indication of UF or FI may also be enrolled) Has a diagnosis of UUI for greater than or equal to 6 months prior to the date of consent UUI episodes: For currently implanted participants (Group A), they must be considered therapy responders with a >50% reduction in UUI episodes (based on their original baseline diaries) and satisfied with their SNM therapy For de novo candidates (Group B), they must have completed a successful PNE documented with a >50% reduction in UUI episodes on a 3-day diary (a diary must exist within a medical record or equivalent) Willing and capable of providing informed consent Agrees to return to the site for all study visits Fluent (able to speak and read) in English Exclusion Criteria: Any participant that the study Investigator deems to be a poor candidate who is unable to complete a 72-hour bladder diary or will be non-compliant for study visits Diagnosis of urinary retention Surgical treatment for stress incontinence (e.g. sling, Burch), and/or pelvic organ prolapse in the past 3 months or recommended or planned within 3 months from the time of consent Changes to current regimen of medications that could impact bladder function within 4 weeks prior to consent Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture) Current symptomatic urinary tract infection (UTI) A patient who early discontinued from the ARTISTRY registry A female with a positive urine pregnancy test A female who is breastfeeding

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Implanted group<br>This group will be participants with urinary urge incontinence (UUI) who have been previously implanted with an Axonics System and are satisfied with therapy | Device: Axonics System<br>* The Axonics System will be implanted as standard care<br>|
| De Novo group<br>This group will be participants who are newly implanted with an Axonics System. | Device: Axonics System<br>* The Axonics System will be implanted as standard care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of daily cyclic stimulation of 2 hours on and 22 hours off in reducing UUI episodes by > 50% in newly implanted participants, or maintenance of efficacy in currently implanted participants with an implanted Axonics System | Comparison of UUI episodes on a 3-day bladder diary at 3 months as compared to baseline UUI episodes | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate patient satisfaction with cyclic stimulation | Analysis of the Patient Global Impression of Improvement (PGI-I) scale. This scale evaluates the post-operative condition. The PGI-I has 1 question with 7 possible answers ranging from very much better (score of 1) to very much worse (score of 7). | 3 months |