An Implantable Microstimulator for the Chronic Treatment of Urinary Urgency-Frequency Syndrome

Phase 3

Completed

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

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

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.
Have anatomical restrictions such that the study device placement is not possible.
Are currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function.
Cannot independently comprehend and complete the questionnaires.

Arm && Interventions

Group	Intervention	Description
1	bion	Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
2	bion	No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.

Primary Outcome Measures

Name	Time	Method
Average Number of Voids Per Day	12 months
Freedom From Major Complications	5 years

Secondary Outcome Measures

Name	Time	Method

Locations (11): Milestone Medical Research
🇺🇸
Englewood, Colorado, United States
William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
Cornerstone Medical Specialty Center
🇺🇸
Woodbury, Minnesota, United States
The Pelvic and Sexual Health Institute
🇺🇸
Philadelphia, Pennsylvania, United States
Dallas Center for Pelvic Medicine
🇺🇸
Dallas, Texas, United States
Arizona Health Sciences Center
🇺🇸
Tucson, Arizona, United States
New York University
🇺🇸
New York, New York, United States
The Department of Urology, Stanford University Medical Center
🇺🇸
Stanford, California, United States
Walter Reed Army Medical Center
🇺🇸
Washington, District of Columbia, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Overland Park Regional Medical Center
🇺🇸
Overland Park, Kansas, United States