AURA-2: Augmenting Urinary Reflex Activity

Amber Therapeutics

Status

Completed

Conditions

Urge Incontinence

Overactive Bladder

Treatments

Device: Amber UI System

Study type

Interventional

Funder types

Industry

Identifiers

NCT05241379

Amber AURA-2

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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