Urinary Incontinence, Urge Clinical Trial
Official title:
Randomized, Multi-Center Pivotal Study for Sacral Nerve Stimulation to Treat Refractory Urgency Urinary Incontinence With Wireless Neuromodulation Technology
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.
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.
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