Overactive Bladder Syndrome, Sacral Neuromodulation, Urinary Urge Incontinence
Conditions
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.
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.
Interventions
DEVICEAxonics System
The Axonics System will be implanted as standard care
Sponsors
Axonics, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Participants who are ≥ 21 years at the time of consent 2. Has a primary indication of UUI (participants with a secondary indication of UF or FI may also be enrolled) 3. Has a diagnosis of UUI for greater than or equal to 6 months prior to the date of consent 4. UUI episodes: 1. 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 2. 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) 5. Willing and capable of providing informed consent 6. Agrees to return to the site for all study visits 7. Fluent (able to speak and read) in English
Exclusion criteria
1. 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 2. Diagnosis of urinary retention 3. 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 4. Changes to current regimen of medications that could impact bladder function within 4 weeks prior to consent 5. Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture) 6. Current symptomatic urinary tract infection (UTI) 7. A patient who early discontinued from the ARTISTRY registry 8. A female with a positive urine pregnancy test 9. A female who is breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Outcome results
None listed