Completed
Battery Powered Bion Clinical Investigation: An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence
What is being tested
bion
Device
Who is being recruted
Urogenital Diseases+8
+ Female Urogenital Diseases and Pregnancy Complications
+ Signs and Symptoms
Over 18 Years
+14 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 3
Interventional
Study Start: June 2003
Summary
Principal SponsorBoston Scientific Corporation
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2003
Actual date on which the first participant was enrolled.This clinical trial is being conducted to investigate the safety and effectiveness of a new device designed to treat urinary urge incontinence in those patients who have tried and failed two or more conservative therapies.
Official TitleBattery Powered Bion Clinical Investigation: An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence
Principal SponsorBoston Scientific Corporation
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
148 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary IncontinenceUrination DisordersUrologic DiseasesUrological ManifestationsFemale Urogenital DiseasesMale Urogenital DiseasesLower Urinary Tract Symptoms
Criteria
14 exclusion criteria prevent from participating
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 months period.
Less than one year post partum and/or are breast-feeding.
Have any passive implant that contains metal or electrically conductive materials.
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalStimulation 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.
Group II
ShamNo Stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 11 locations
Suspended
Arizona Health Sciences Center (University of Arizona)
Tucson, United StatesOpen Arizona Health Sciences Center (University of Arizona) in Google MapsSuspended
The Department of Urology, Stanford University Medical Center
Stanford, United StatesSuspended
Milestone Medical Research
Englewood, United StatesSuspended
Bladder Control Center of Norwalk
Norwalk, United StatesCompleted11 Study Centers