aura-2: augmenting urinary reflex activity

Conditions: Overactive Bladder; Urge Incontinence

Summary: amber aura-2 study (augmenting urinary reflex activity 2) is a short-duration (6 month) safety and electrophysiological study using an implanted amber ui system and two electrode leads to provide closed-loop pudendal nerve stimulation for the treatment of urinary incontinence.


Eligibility criteria:
inclusion criteria: * female patients aged ≥ 18 years * diagnosis of urinary incontinence, with on a 5-day voiding diary at least 1 daily urgency episode and/or greater than or equal to 8 voids/day and/or by having a minimum of two involuntary leaking episodes in 72 hr * duration of urinary incontinence symptom ≥ 6 months prior to the screening baseline visit date * failed or is not a candidate for more conservative treatment e.g. pelvic floor muscle therapy or biofeedback or behavioral modification * failed or could not tolerate at least one (1) antimuscarinic or beta3-adrenoceptor agonist medication * urodynamic testing (uroflowmetry, cystometry and pressure flow) completed within 12 months prior to screening baseline visit date or is willing to have testing at screening baseline visit * cystoscopy test completed within 12 months prior to the screening baseline visit date or is willing to have a test at screening baseline visit * is willing and able to washout from oab medications for at least 4 week prior to beginning the baseline voiding diary * ability and willingness to give informed consent including language constraints (see above) * able to participate in all testing and follow-up clinic visits associated with study protocol * capable of independently using the system components (after training) as described in the patient manual * mobile and able to use toilet without assistance exclusion criteria: general: * patient is pregnant, breastfeeding, or plans to become pregnant during the course of the study (pregnancy tests provided in schedule) * patient is unwilling or unable to use contraception during sexual intercourse for the duration of the study, and thereafter if implant remains in the longer term. * 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 * any neurological condition that may interfere with normal bladder function (e.g., stroke, multiple sclerosis, parkinson's disease; clinically significant peripheral neuropathy, or complete spinal cord injury) * patient has uncontrolled type i or type ii diabetes as defined by their routine care clinician or diabetes with peripheral nerve involvement * any history of any pelvic cancer * patient has history of other non-pelvic neoplasia within 5 years prior to enrolment, except for a cancer that was determined to be local occurrence only, such as basal cell carcinoma, or is receiving or planning to receive anti-cancer or anti-angiogenic drugs * patient has proven major autoimmune disease, e.g. scleroderma or immunodeficiency (including use of biologic immunomodulatory drugs at time of procedure) * life expectancy of less than 1 year * patient is a frail elderly and/or with notable clinical evidence of sarcopaenia * patient is not suitable for the study as determined by their routine care physician for any other reason * patient is enrolled in another interventional study excepting observational studies, e.g. snm registries or in relation to disease (see below) * patient participation in vigorous sporting activities where these cannot be restricted for a period of 6 weeks post-implantation. specific urological * urinary tract mechanical obstruction such as urethral stricture * current symptomatic urinary tract infection (uti) or more than 3 utis in past year * pure stress incontinence or mixed incontinence where the stress component overrides the urge component * interstitial cystitis or bladder pain syndrome as defined by either aua or eau guidelines * suspected pudendal nerve entrapment syndrome. in patients with co-existent symptoms of chronic pelvic pain and urinary incontinence, nantes criteria will be used for screening. patients meeting essential criteria will be excluded from the study * treatment of urinary symptoms with botulinum toxin therapy in the past 12 months * prior attempt at pudendal nerve stimulation using an implanted lead * treatment of urinary symptoms with tibial or sacral nerve stimulation in the past 3 months (prior experience of either before this time is permitted provided no implants remain in-situ) specific technical * patient is significantly obese (defined as bmi ≥ 35) so as to limit electrode lead placement using standard approaches * skin, orthopaedic or neurological anatomical limitations that could prevent successful placement of the electrode lead * knowledge of planned mris, diathermy, microwave exposure, high output ultrasonic exposure, or rf energy exposure * implantable neurostimulator, pacemaker or defibrillator in situ (anywhere in body including sacral and tibial) * subject with a documented history of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone