Status:
COMPLETED
AURA-2: Augmenting Urinary Reflex Activity
Lead Sponsor:
Amber Therapeutics Ltd
Conditions:
Overactive Bladder
Urge Incontinence
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief 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 clos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2024
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05241379
Start Date
November 30 2022
End Date
April 15 2024
Last Update
August 12 2024
Active Locations (1)
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1
University Hospital Antwerp
Antwerp, Belgium, 2650