CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 118 enrolled
Drug / intervention
biondevice
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Age 18 years or older
  • ✓Diagnosed with urinary urgency-frequency syndrome
  • ✓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
  • ✕Less than one year post partum and/or breast-feeding
  • ✕Large passive metal implant within 30 cm of chair pad when seated (e.g., hip replacement)

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

Search/NCT00131573
NCT00131573Phase 3Completed
CompareCT.gov

Battery Powered Bion Clinical Investigation: Bion - An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urgency-Frequency Syndrome

Boston Scientific Corporation·interventional·Posted Aug 19, 2005·Updated Nov 19, 2013

In Brief

A Phase 3 clinical trial evaluating bion for Overactive Bladder. Completed, enrolled 118 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 19, 2005
Enrollment StartMay 1, 2004
Primary CompletionMar 1, 2008
Study CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.9 years ago

Interventions

biondevice

battery powered bion microstimulator