Overactive Bladder
Conditions
Keywords
Urgency-Frequency, Syndrome, Urinary, Refractory, Stimulation, Nerve, Neuromodulation, Microstimulator, bion, Pudendal, Overactive bladder
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.
Interventions
DEVICEbion
battery powered bion microstimulator
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion criteria: * Age 18 years and above. * Diagnosed with urinary urgency-frequency syndrome. * Have no reported history of urethral obstruction/stricture, bladder calculi or bladder tumor. * Have normal upper urinary tract function. * Be capable of giving informed consent. * Be capable and willing to follow all study related procedures. Key
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average Number of Voids Per Day | 12 months |
| Freedom From Major Complications | 5 years |
Countries
United States
Participant flow
Pre-assignment details
Although enrollment numbers totaled 118 subjects, the total number of implanted subjects were used for the analysis. Total number of implanted subjects is 85.
Participants by arm
| Arm | Count |
|---|---|
| Control No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on. | 46 |
| Treatment 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. | 39 |
| Total | 85 |
Baseline characteristics
| Characteristic | Control | Treatment | Total |
|---|---|---|---|
| Age, Customized | 47.96 Years STANDARD_DEVIATION 11.66 | 46.64 Years STANDARD_DEVIATION 15.55 | 47.35 Years STANDARD_DEVIATION 13.53 |
| Sex/Gender, Customized Female | 39 participants | 33 participants | 72 participants |
| Sex/Gender, Customized Male | 6 participants | 6 participants | 12 participants |
| Sex/Gender, Customized Unknown | 1 participants | 0 participants | 1 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 30 / 46 | 21 / 39 |
| serious Total, serious adverse events | 0 / 46 | 0 / 39 |
Outcome results
Primary
Average Number of Voids Per Day
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Average Number of Voids Per Day | NA Average Number of Voids |
| Control | Average Number of Voids Per Day | NA Average Number of Voids |
Primary
Freedom From Major Complications
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Freedom From Major Complications | 0 Number of Adverse Events |
| Control | Freedom From Major Complications | 0 Number of Adverse Events |