Overactive Bladder Urinary Urgency
Conditions
Interventions
All patients will receive the Axonics SNM System and will have to complete
extra questionnaires and will have extra follow-up visits to standard of
care.
Incontinence
Neuromodulation
Sacral
Urge
Sponsors
AXONICS MODULATION TECHNOLOGIES. INC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Diagnosis of UUI demonstrated on a 72-hour voiding diary defined as: * a minimum of four (4) leaking episodes associated with urgency, * at least 50% of all leaking episodes associated with urgency, and * at least one leaking episode each 24-hour period. ;Greater than or equal to 6 months* history of UUI diagnosis;For male subjects only: * Peak flow rate > 15 cc/s as verified by uroflowmetry within 6 months prior to enrollment * Residual bladder volume
Exclusion criteria
Exclusion criteria: More than minimal level of stress incontinence or mixed incontinence with stress component likely to confound study outcome. ;Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture);Interstitial cystitis or bladder pain syndrome as defined by either AUA or EAU guidelines;Chronic pelvic pain;History of any pelvic cancer;Uncontrolled hypertension;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, chronic pain, etc.);Any psychiatric or personality disorder at the discretion of the study physician;PHQ-15 score of *15 ;Current symptomatic urinary tract infection (UTI) or more than three (3) UTIs in past year;Any neurological condition that could interfere with normal bladder function, including stroke, epilepsy, multiple sclerosis, Parkinson*s disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia);Uncontrolled diabetes (A1C > 6.5, documented in the last three (3) months) ;Diabetes with peripheral nerve involvement;Treatment of urinary symptoms with botulinum toxin therapy within twelve (12) months prior to SNM implant date;Treatment of urinary symptoms with tibial nerve stimulation within three (3) months prior to SNM implant date;Previously implanted with a sacral neuromodulation device;Underwent an external trial and was deemed a non-responder ;Pelvic organ prolapse stage 3 or higher;History of pelvic floor surgery, including surgical treatment for stress incontinence or prolapse, within 6 months prior to SNM implant date;Surgical treatment for stress incontinence (sling, Burch or urethral injection) or pelvic organ prolapse recommended or planned at enrollment ;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 (e.g., drug delivery pumps, pacemaker, ICD) including neurostimulators 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;A female with a positive urine pregnancy test ;Currently participating in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Effectiveness Endpoint: Proportion of all implanted subjects that are Treatment Responders (i.e. subjects with *50% reduction in the number of urgency leaks) is greater than 50% at 6-months post activation. Primary Safety Endpoint: Rate of adverse events (AEs) at 6 months post-activation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: The following secondary endpoints are planned in all implanted subjects at 6-month follow-up * Improvement from baseline in ICIQ-OABqol total score (HRQL) * Reduction from baseline in average daily number of urgency leaks * Reduction from baseline in average daily number of large urgency leaks * Reduction from baseline in average daily urgency * Improvement from baseline in average daily number of voids Additionally, the following endpoint is planned in Trial Responders cohort at 6-month follow-up: * Responder rate | — |
Countries
The Netherlands
Outcome results
None listed