Battery Powered Bion Clinical Investigation: Bion - An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urgency-Frequency Syndrome

Boston Scientific Corporation11 sites in 1 country118 target enrollmentMay 2004

Overview

The goal of this study is to investigate the safety and effectiveness of a new implanted device designed to treat Urinary Urgency-Frequency Syndrome.

Registry

clinicaltrials.gov

Start Date

May 2004

End Date

December 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Have any active implantable device regardless of whether stimulation status is ON or OFF.
•Are pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the following 12 month period.
•Less than one year post partum and/or are breast-feeding.
•Have any large passive implant that contains metal located within 30 cm of the chair pad while seated (e.g., hip replacement).
•Have conditions requiring magnetic resonance imaging (MRI) evaluation.
•Have conditions requiring diathermy procedures.
•Have an inability to operate the bion Remote Control and bion Recharging System either by self or caregiver.
•Have diabetes with peripheral nerve involvement or have severe uncontrolled diabetes.
•Have history of coagulopathy or bleeding disorder.
•Have pelvic pain in the absence of voiding dysfunction.