Cycling Study With the Axonics System
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Implanted group This group will be participants with urinary urge incontinence (UUI) who have been previously implanted with an Axonics System, are considered therapy responders (>50% reduction in UUI episodes) and are satisfied with therapy |
Device: Axonics System
The Axonics System will be implanted as standard care
|
| De Novo group This group will be participants who are newly implanted with an Axonics System. |
Device: Axonics System
The Axonics System will be implanted as standard care
|
Outcome Measures
Primary Outcome Measures
- 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 [3 months]
Comparison of UUI episodes on a 3-day bladder diary at 3 months as compared to baseline UUI episodes
Secondary Outcome Measures
- To evaluate patient satisfaction with cyclic stimulation [3 months]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participants who are ≥ 21 years at the time of consent
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Has a primary indication of UUI (participants with a secondary indication of UF or FI may also be enrolled)
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Has a diagnosis of UUI for greater than or equal to 6 months prior to the date of consent
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UUI episodes:
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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
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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)
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Willing and capable of providing informed consent
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Agrees to return to the site for all study visits
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Fluent (able to speak and read) in English
Exclusion Criteria:
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Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study objectives (e.g. bladder pain syndrome, moderate to severe fibromyalgia, or chronic pain)
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Any psychiatric or mental disorders that could affect cognition or decision making
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Any neurological conditions that could interfere with normal bladder function, including stroke, epilepsy, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)
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Uncontrolled diabetes (HbA1C > 8, documented in the last 3 months) or diabetic neuropathy,
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Diagnosis of mixed urinary incontinence with a predominant stress component
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History of bladder pain syndrome (as defined by American Urological Association (AUA) or European Association of Urology (EAU) guidelines)
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Diagnosis of chronic pelvic pain
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History of any pelvic cancer
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Diagnosis of urinary retention
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Has a history of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
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Treatment of urinary symptoms with botulinum toxin therapy within 9 months prior to consent
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Treatment of urinary symptoms with tibial nerve stimulation within 3 months prior to consent
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Surgical treatment for stress incontinence (e.g. sling, Burch or urethral bulking), and/or pelvic organ prolapse in the past 6 months or recommended or planned within 6 months from the time of consent
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Changes to current regimen of medications that affect bladder function within 4 weeks prior to consent
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Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture)
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Current symptomatic urinary tract infection (UTI) or > 3 UTIs in the last year (at time of consent)
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Currently participating in another clinical trial
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Early discontinuation from the ARTISTRY registry
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A female with a positive urine pregnancy test
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A female who is breastfeeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Center for Pelvic Health | Franklin | Tennessee | United States | 37067 |
Sponsors and Collaborators
- Axonics Modulation Technologies, Inc.
Investigators
- Study Director: Karen Noblett, MD, Axonics, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 105-0095