Sacral Nerve Stimulation to Treat Urgency Urinary Incontinence With Wireless Neuromodulation

This is an interventional treatment trial for Urinary Incontinence, Urge Read More

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).