An Implantable Microstimulator for the Chronic Treatment of Urinary Urgency-Frequency Syndrome

Boston Scientific

Status and phase: Completed; Phase 3

Conditions: Overactive Bladder

Treatments: Device: bion

Study type: Interventional

Funder types: Industry

Identifiers

NCT00131573

CR-B-002

Details and patient eligibility

About

The goal of this study is to investigate the safety and effectiveness of a new implanted device designed to treat Urinary Urgency-Frequency Syndrome.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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118 participants in 2 patient groups

1

Experimental group

Description:

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.

Treatment:

Device: bion

2

Sham Comparator group

Description:

No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.

Treatment:

Device: bion