Urinary IncontinencePhase 3NCT00080470

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

A Phase 3 study testing bion in people with Urinary Incontinence, run by Boston Scientific Corporation at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Urinary Incontinence
What is being tested?: bion
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 148 participants
Where: 11 sitesUnited States
Study dates: Jun 2003to Dec 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 years and above.
Diagnosed with urinary urge incontinence.
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.

Who cannot join

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 months period.
Less than one year post partum and/or are breast-feeding.
Have any passive implant that contains metal or electrically conductive materials.
Have conditions requiring Magnetic Resonance Imaging (MRI) evaluation.
Have conditions requiring diathermy procedures.

Show all 14Show fewer

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 a history of pelvic pain as primary diagnosis.
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.
Have a life expectancy of less than 1 year.
Cannot independently comprehend and complete the QoL questionnaires.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Dallas Center for Pelvic Medicine
Dallas, Texas, 75231
Sound Urological Associates
Edmonds, Washington, 98026
Milestone Medical Research
Englewood, Colorado, 80112
Baylor College of Medicine
Houston, Texas, 77030
Bladder Control Center of Norwalk
Norwalk, Connecticut, 06850
The Pelvic and Sexual Health Institute (affiliated with Graduate Hospital)
Philadelphia, Pennsylvania, 19146
William Beaumont Hospital
Royal Oak, Michigan, 48073
The Department of Urology, Stanford University Medical Center
Stanford, California, 94305-5118
Arizona Health Sciences Center (University of Arizona)
Tucson, Arizona, 85724
Walter Reed Army Medical Center, Division of Pelvic Medicine and Reconstructive Surgery
Washington D.C., District of Columbia, 20307-5001
Cornerstone Medical Specialty Center
Woodbury, Minnesota, 55125

Other trials in United States

About this study

Official title: Battery Powered Bion Clinical Investigation: An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence

Conditions: Urinary Incontinence
Being tested: bion
Keywords: Incontinence, Refractory, Urinary, Urge, Stimulation, Nerve, Microstimulator, Neuromodulation
Medical subject headings: Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bionDevice
battery powered microstimulator

Study groups in NCT00080470
Study group	Role	What they receive
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. Receives: Device: bion
2	Sham comparator	No Stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on. Receives: Device: bion

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Leaks Per Day
Measured: 12 months
Freedom From Major Complications
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2003Dec 2012

First posted5 Apr 2004 (estimated)
Study startJun 2003
Primary completionJul 2008
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 148 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00080470
Sponsor's protocol ID: CR-B-001
Status last verified: Oct 2013
First submitted: 1 Apr 2004
Last updated: 19 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)

All Urinary Incontinence trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Battery Powered Bion Clinical Investigation: An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence
ClinicalTrials.gov ID: NCT00080470
Acronym / sponsor ID: CR-B-001
Conditions: Urinary Incontinence
Keywords: Incontinence, Refractory, Urinary, Urge, Stimulation, Nerve, Microstimulator, Neuromodulation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 148 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: Jun 2003
Primary completion: Jul 2008 (actual)
Study completion: Dec 2012 (actual)
First posted: 5 Apr 2004 (estimated)
Results: Posted 10 Oct 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Device: bionStimulation 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.
2	Sham comparator	Device: bionNo Stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age 18 years and above.
Diagnosed with urinary urge incontinence.
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.

Key exclusion criteria (14 listed)

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 months period.
Less than one year post partum and/or are breast-feeding.
Have any passive implant that contains metal or electrically conductive materials.
Have conditions requiring Magnetic Resonance Imaging (MRI) evaluation.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
bionbattery powered microstimulator	Device	1, 2

Primary outcome

Number of Leaks Per Day
Time frame: 12 months
Freedom From Major Complications
Time frame: 5 years

Results and safety

Results posted to the registry on 10 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	45	11
Control	42	14

Primary outcome: Number of Leaks Per Day

Time frame: 12 months. Mean (Standard Deviation). Unit: Number of Leaks Per Day

Measure	Treatment n = 45	Control n = 42
Value	NA (NA)	NA (NA)

Primary outcome: Freedom From Major Complications

Time frame: 5 years. Number. Unit: Number of Adverse Events

Measure	Treatment n = 45	Control n = 42
Value	0 (NA)	0 (NA)

Adverse events

Time frame: 5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 42 (0%)	35 of 42 (83.3%)	Not reported
Treatment	0 of 45 (0%)	32 of 45 (71.1%)	Not reported

Limitations and caveats (from the sponsor): This study was limited by poor adherence to the clinical protocol and by incomplete data recovery. Analysis of efficacy-related endpoints was not possible.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Urinary Incontinence

Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tamara Baynham, PhD study director

Boston Scientific, Neuromodulation

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bion in people with Urinary Incontinence, run by Boston Scientific Corporation at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Leaks Per Day (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00080470.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2013.