NCT02434874

Sacral Nerve Stimulation to Treat Urgency Urinary Incontinence With Wireless Neuromodulation

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Uro Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Urinary Incontinence, Urge

Interventions

Type	Name	Description
DEVICE	StimGuard Sacral Nerve Stimulator System	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.

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-12-01
• Completion: 2022-12-01
• First posted: 2015-05-05
• Last updated: 2020-09-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study