Treatment of REfractory Overactive BLadder With the AXonics Sacral Neuromodulation System (RELAX-OAB)

Inclusion criteria

• Diagnosis of OAB as demonstrated on a 3-day voiding diary defined as ≥ 8 voids/day, and/or a minimum of 2 involuntary leaking episodes in a 72-hour period
• Positive motor response on at least two implanted electrodes during intraoperative test
• 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 the baseline voiding diary
• Willing and capable of providing informed consent
• Capable of participating in all testing associated with this clinical investigation

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
• 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, 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