CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 148 enrolled
Drug / intervention
biondevice
Likely dose
Bion battery-powered microstimulator (implantable device)AI-extracted
Key inclusion· 5
  • ✓Age 18 years or older
  • ✓Diagnosed with urinary urge incontinence
  • ✓No history of urethral obstruction/stricture, bladder calculi, or bladder tumor
  • ✓Normal upper urinary tract function
Key exclusion· 13
  • ✕Any active implantable device (regardless of stimulation status)
  • ✕Pregnant or planning pregnancy within 12 months, or less than 1 year postpartum, or breast-feeding
  • ✕Passive implant containing metal or electrically conductive materials
  • ✕Conditions requiring MRI evaluation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00080470
NCT00080470Phase 3Completed
CompareCT.gov

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

Boston Scientific Corporation·interventional·Posted Apr 5, 2004·Updated Nov 19, 2013

In Brief

A Phase 3 clinical trial evaluating bion for Urinary Incontinence. Completed, enrolled 148 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Incontinence
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 5, 2004
Enrollment StartJun 1, 2003
Primary CompletionJul 1, 2008
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 22.2 years ago

Interventions

biondevice

battery powered microstimulator