OAB overactive bladder
Conditions
Interventions
Implant of the Axonics SNM system.
Sponsors
Axonics Modulation Technologies, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Diagnosis of OAB as demonstrated on a 3-day voiding diary defined as * 8 voids/day, and/or a minimum of two involuntary leaking episodes in a 72-hour period - Positive motor response on at least two implanted electrodes during intraoperative test - 18 years of age or older - Failed, or are not a candidate for more conservative treatment (e.g., pelvic floor training, biofeedback, behavioral modification, oral pharmacotherapy) No changes to current regimen of medications that affect bladder function for at least 4 weeks prior to beginning and completing the baseline voiding diary and baseline questionnaires - Willing and capable of providing informed consent - Capable of participating in all testing associated with this clinical investigation
Exclusion criteria
Exclusion criteria: - Primary stress incontinence or mixed incontinence where the stress component overrides the urgency component - Current urinary tract mechanical obstruction such as benign prostatic enlargement or urethral stricture - Interstitial cystitis or bladder pain syndrome as defined by either AUA or EAU guidelines - History of any pelvic cancer - Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints (e.g. Crohn*s disease, moderate to severe fibromyalgia, etc.) - Any psychiatric or personality disorder at the discretion of the study physician - PHQ-9 Patient Depression Score * 10 - Current symptomatic urinary tract infection (UTI) or more than 3 UTIs in past year - Any neurological condition that may interfere with normal bladder function, including stroke, multiple sclerosis, Parkinson*s disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia) - Severe or uncontrolled diabetes (A1C > 8, documented in the last 3 months) or diabetes with peripheral nerve involvement - Treatment of urinary symptoms with botulinum toxin therapy in the past 12 months - Treatment of urinary symptoms with tibial nerve stimulation in the past 3 months - Previously implanted with a sacral neuromodulation device or participated in a sacral neuromodulation trial - Subject with a documented history of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone - Knowledge of planned MRIs on areas other than the head, diathermy, or high output ultrasonic exposure - Any other active implanted devices including neurostimulators (e.g., cochlear implant, pacemaker) and/or drug delivery pumps, whether turned on or off - Passive implants (e.g., prostheses) are allowed, but no implanted metal should be at the Neurostimulator implant site - A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception - Participation in a current clinical trial or within the preceding 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Effectiveness Endpoint: Mean change in ICIQ-OABqol HRQL Total Score at 3 months compared to baseline Safety Measures: -Serious adverse device effects (SADEs) -Adverse device effects (ADEs) -Adverse procedure effects (APEs) -Serious adverse events (SAEs) -Adverse events (AEs) | — |
Secondary
| Measure | Time frame |
|---|---|
| Performance Measures: -Device performance metrics -Average leaks per day (3-day voiding diary) -Average voids per day (3-day voiding diary) -Percent of subjects with successful treatment, defined as either 1) a 50% improvement in the number of average leaks or the number of voids per day or 2) a return to a normal number of voids per day ( | — |
Countries
Netherlands
Outcome results
None listed