Clinical trial NCT00131573: An Implantable Microstimulator for the Chronic Treatment of Urinary Urgency-Frequency Syndrome
Official title: Battery Powered Bion Clinical Investigation: Bion - An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urgency-Frequency Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Keywords: Urgency-Frequency
Syndrome
Urinary
Refractory
Stimulation
Nerve
Neuromodulation
Microstimulator
bion
Pudendal
Overactive bladder
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-08-19
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Average Number of Voids Per Day
timeFrame: 12 months
measure: Freedom From Major Complications
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Health Sciences Center
state: Arizona
city: Stanford
country: United States
facility: The Department of Urology, Stanford University Medical Center
state: California
city: Englewood
country: United States
facility: Milestone Medical Research
state: Colorado
city: Washington
country: United States
facility: Walter Reed Army Medical Center
state: District of Columbia
city: Overland Park
country: United States
facility: Overland Park Regional Medical Center
state: Kansas
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Woodbury
country: United States
facility: Cornerstone Medical Specialty Center
state: Minnesota
city: New York
country: United States
facility: New York University
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: The Pelvic and Sexual Health Institute
state: Pennsylvania
city: Dallas
country: United States
facility: Dallas Center for Pelvic Medicine
state: Texas
Study officials:
affiliation: Boston Scientific, Neuromodulation
name: Tamara Baynham, PhD
role: STUDY_DIRECTOR
References: