Battery Powered Bion Clinical Investigation: An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence
bion
Urogenital Diseases+7
+ Female Urogenital Diseases and Pregnancy Complications
+ Urinary Incontinence
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.148 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Key Inclusion Criteria: 1. Age 18 years and above. 2. Diagnosed with urinary urge incontinence. 3. Have no reported history of urethral obstruction/stricture, bladder calculi or bladder tumor. 4. Have normal upper urinary tract function. 5. Be capable of giving informed consent. 6. Be capable and willing to follow all study related procedures. Key Exclusion Criteria: 1. Have any active implantable device regardless of whether stimulation status is ON or OFF. 2. Are pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the following 12 months period. 3. Less than one year post partum and/or are breast-feeding. 4. Have any passive implant that contains metal or electrically conductive materials. 5. Have conditions requiring Magnetic Resonance Imaging (MRI) evaluation. 6. Have conditions requiring diathermy procedures. 7. Have an inability to operate the bion Remote Control and bion Recharging System either by self or caregiver. 8. Have diabetes with peripheral nerve involvement or have severe uncontrolled diabetes. 9. Have history of coagulopathy or bleeding disorder. 10. Have a history of pelvic pain as primary diagnosis. 11. Have anatomical restrictions such that the study device placement is not possible. 12. Are currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function. 13. Have a life expectancy of less than 1 year. 14. Cannot independently comprehend and complete the QoL questionnaires.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ShamStudy 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
The Department of Urology, Stanford University Medical Center
Stanford, United StatesMilestone Medical Research
Englewood, United StatesBladder Control Center of Norwalk
Norwalk, United States