Axonics SacRal NeuromodulaTIon System for UrinAry Urgency Incontinence TreatmeNt

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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 < 150 cc tested within 6 months prior to enrollment;Positive motor response on at least two (2) implanted electrodes during intraoperative test in the S3 (preferred) or S4 foramen;21 years of age and older;For patients* over 70 years of age, or any patient at the discretion of the Investigator, Edmonton Frail Scale score of 9 or less;Failed conservative therapy and second-line drug therapy and is not a candidate for additional conservative or second-line therapy ;No changes to current regimen of medications that affect bladder function for at least four (4) weeks prior to beginning the baseline voiding diary and baseline questionnaires;Willing and capable of providing informed consent;Capable of participating in all testing associated with this clinical investigation

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Effectiveness Endpoint:<br /><br><br /><br>Proportion of all implanted subjects that are Treatment Responders (i.e.<br /><br>subjects with *50% reduction in the number of urgency leaks) is greater than<br /><br>50% at 6-months post activation.<br /><br><br /><br>Primary Safety Endpoint:<br /><br><br /><br>Rate of adverse events (AEs) at 6 months post-activation</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Endpoints:<br /><br><br /><br>The following secondary endpoints are planned in all implanted subjects at<br /><br>6-month follow-up<br /><br><br /><br><br /><br>* Improvement from baseline in ICIQ-OABqol total score (HRQL)<br /><br><br /><br>* Reduction from baseline in average daily number of urgency leaks<br /><br><br /><br>* Reduction from baseline in average daily number of large urgency leaks<br /><br><br /><br>* Reduction from baseline in average daily urgency<br /><br><br /><br>* Improvement from baseline in average daily number of voids<br /><br><br /><br>Additionally, the following endpoint is planned in Trial Responders cohort at<br /><br>6-month follow-up:<br /><br>* Responder rate</p><br>