NCT00131573CompletedPhase 3
Battery Powered Bion Clinical Investigation: Bion - An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urgency-Frequency Syndrome
Boston Scientific Corporation11 sites in 1 country118 target enrollmentStarted: May 1, 2004Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 118
- Locations
- 11
- Primary Endpoint
- Average Number of Voids Per Day
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Arms & Interventions
1
Experimental
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.
Intervention: bion (Device)
2
Sham Comparator
No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
Intervention: bion (Device)
Outcomes
Primary Outcomes
Average Number of Voids Per Day
Time Frame: 12 months
Freedom From Major Complications
Time Frame: 5 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (11)
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