Sacral Nerve Stimulation to Treat Urgency Urinary Incontinence With Wireless Neuromodulation

Study Overview
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Brief Summary
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The purpose of this pivotal study is to illustrate the safety and effectiveness of the StimGuard Sacral Nerve Stimulation (SNS) System in the treatment refractory urge incontinence. This is a prospective, randomized, controlled, multi-center, study in which 92 subjects will receive a StimGuard SNS System.

Detailed Description
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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.

Official Title
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Randomized, Multi-Center Pivotal Study for Sacral Nerve Stimulation to Treat Refractory Urgency Urinary Incontinence With Wireless Neuromodulation Technology

Conditions
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Urinary Incontinence, Urge

Intervention / Treatment
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* Device: StimGuard Sacral Nerve Stimulator System


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Activation<br>Subjects randomized to this group will have the StimGuard Sacral Nerve Stimulator System activated immediately. | Device: StimGuard Sacral Nerve Stimulator System<br>* The StimGuard Sacral Nerve Stimulator System is a wirelessly powered neurostimulator for urge urinary incontinence. This technology includes a quadripolar stimulator with an embedded receiver. The energy source is a small, external, rechargeable transmitter, which is worn by the patient. The transmitter sends the therapy program and power through the skin and to the receiver.<br>|
| Other: Delayed Activation<br>Subjects randomized to this group will have the StimGuard Sacral Nerve Stimulator System activated after 90 days. | Device: StimGuard Sacral Nerve Stimulator System<br>* The StimGuard Sacral Nerve Stimulator System is a wirelessly powered neurostimulator for urge urinary incontinence. This technology includes a quadripolar stimulator with an embedded receiver. The energy source is a small, external, rechargeable transmitter, which is worn by the patient. The transmitter sends the therapy program and power through the skin and to the receiver.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in number of urge related incontinence episodes | Self reported on a 3-day voiding diary | 3 Months | 
| Incidence and severity of adverse events |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with a reduction in the degree of urgency as measured by PPIUS | Self reported on a 3-day voiding diary | 3 Months | 
| Proportion of subjects with a reduction in the number of voids compared to baseline | Self reported on a 3-day voiding diary | 3 Months | 
| Improved quality of life function via the Incontinence Quality of Life Scale (I-QOL) | Quesionnaire | 3 Months |