Sacral Nerve Stimulation to Treat Urgency Urinary Incontinence With Wireless Neuromodulation

The StimGuard SNS System is utilized for the treatment of refractory urgency urinary
incontinence as defined by the International Continence Society (ICS) Standardization of
Terminology Committees Joint Report as the observation of involuntary leakage from the
urethra synchronous with the sensation of a sudden, compelling desire to void that is
difficult to defer. The system provides treatment by delivering small controlled electrical
pulses to the sacral nerves, as these nerves have been shown to regulate the micturition
cycle.

In this study, subjects will be randomized into one of two groups with a 1:1 ratio after
enrollment. Subjects will either be randomized to an immediate or a delayed activation group.
An intraoperative test will be performed, and all subjects will receive a permanent implant
if they have an appropriate motor nerve root response without significant discomfort at 5 mA
amplitude or less.

Inclusion Criteria:

A. Diagnosis of overactive bladder with urgency urinary incontinence; B. Women and men ≥ 18
years of age; C. At least 4 incontinent episodes associated with urge on a 3 day voiding
diary with at least 1 each 24 hour day; D. Self-reported bladder symptoms present > 6
months; E. Self-reported failed conservative care > 6 months (i.e., pharmacology, dietary
restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle
training, biofeedback, etc.); F. Off all antimuscarinics and beta-3 adrenergic agonists for
at least 2 weeks prior to enrollment; G. Have no reported history of urethral
obstruction/stricture, bladder calculi or bladder tumor; H. Normal upper urinary tract
function; I. Capable of giving informed consent; J. Capable and willing to follow all study
related procedures.

Exclusion Criteria:

A. Any active implantable electronic device regardless of whether stimulation is ON or OFF;
B. Pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the
following 12 months period; C. Less than 1 year post partum and/or are breast-feeding; D.
Neurogenic bladder; E. Botox use in bladder or pelvic floor muscles in the past six months;
F. Taking alpha-blocker therapy; G. Have a PVR >150 cc at baseline; H. Primary complaint of
stress urinary incontinence; I. Current urinary tract infection (UTI); J. Previous
treatment with sacral neuromodulation; K. Previous treatment with tibial nerve stimulation,
pelvic floor muscle stimulation, or biofeedback within the past 60 days; L. Conditions
requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures; M. Inability
to operate the StimGuard SNS System; N. Diabetes with peripheral nerve involvement or have
severe uncontrolled diabetes (HbA1C 8.5 or greater); O. History of coagulopathy or bleeding
disorder; P. History of pelvic pain as primary diagnosis (VAS score of > 4); Q. Anatomical
restrictions such that device placement is not possible; R. Currently participating or have
participated within the past 30 days in any clinical investigation involving or impacting
urinary or renal function; S. Life expectancy of less than 5 years; T. Inability to
independently comprehend and complete the questionnaires and diaries; U. Unsuitable for
enrollment in study by the investigators based on subjects' history or physical examination
(including bleeding disorders or anticoagulant medications, and peripheral neuropathy).