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COMPLETED Phase 3

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

NCT00080470 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DEVICE bion

Study Locations (11)

Texas

  • Dallas Center for Pelvic Medicine — Dallas
  • Baylor College of Medicine — Houston

Arizona

  • Arizona Health Sciences Center (University of Arizona) — Tucson

California

  • The Department of Urology, Stanford University Medical Center — Stanford

Colorado

  • Milestone Medical Research — Englewood

Connecticut

  • Bladder Control Center of Norwalk — Norwalk

District of Columbia

  • Walter Reed Army Medical Center, Division of Pelvic Medicine and Reconstructive Surgery — Washington D.C.

Michigan

  • William Beaumont Hospital — Royal Oak

Minnesota

  • Cornerstone Medical Specialty Center — Woodbury

Trial Details

FieldValue
Enrollment Target 148 participants
Start Date 2003-06
Est. Completion 2012-12
Phase Phase 3

Sponsor

Boston Scientific Corporation

120 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00080470

The ClinicalTrials.gov registry entry for NCT00080470 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 148 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 120 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Urinary Incontinence appearing as the primary indexed condition, and to 1 intervention — of which bion is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00080470 reports 11 study locations spanning 10 distinct geographic areas — top geographies include Texas, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00080470 about?

NCT00080470 is a clinical study titled "An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence". 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.

What is the current status of trial NCT00080470?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 148 participants. The study started on 2003-06. Estimated completion is 2012-12.

What conditions does trial NCT00080470 study?

This clinical trial studies the following conditions: Urinary Incontinence. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00080470?

The interventions under investigation include: bion (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00080470?

This trial is sponsored by Boston Scientific Corporation, which has 120 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00080470 being conducted?

This trial has 11 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial