An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence

Boston Scientific

Status and phase: Completed; Phase 3

Conditions: Urinary Incontinence

Treatments: Device: bion

Study type: Interventional

Funder types: Industry

Identifiers

NCT00080470

CR-B-001

Details and patient eligibility

About

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.

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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148 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