Urinary Incontinence
Conditions
Keywords
Incontinence, Refractory, Urinary, Urge, Stimulation, Nerve, Microstimulator, Neuromodulation
Brief summary
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.
Interventions
DEVICEbion
battery powered 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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Leaks Per Day | 12 months |
| Freedom From Major Complications | 5 years |
Countries
United States
Participant flow
Pre-assignment details
Although enrollment numbers totaled 148 subjects, the total number of implanted subjects were used for the analysis. Total number of implanted subjects is 87.
Participants by arm
| Arm | Count |
|---|---|
| Control No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on. | 42 |
| 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. | 45 |
| Total | 87 |
Baseline characteristics
| Characteristic | Control | Treatment | Total |
|---|---|---|---|
| Age, Customized | 59.26 Years STANDARD_DEVIATION 12.66 | 54.82 Years STANDARD_DEVIATION 16.73 | 56.97 Years STANDARD_DEVIATION 14.99 |
| Sex: Female, Male Female | 41 Participants | 40 Participants | 81 Participants |
| Sex: Female, Male Male | 1 Participants | 5 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 35 / 42 | 32 / 45 |
| serious Total, serious adverse events | 0 / 42 | 0 / 45 |
Outcome results
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 |
Primary
Number of Leaks Per Day
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment | Number of Leaks Per Day | NA Number of Leaks Per Day |
| Control | Number of Leaks Per Day | NA Number of Leaks Per Day |