CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 571 enrolled
Drug / intervention
Standard Medical Therapy +1 moredrug
Likely dose
Standard Medical Therapy 2.5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00547378
NCT00547378Phase 4Completed
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Prospective, Multicenter Trial Evaluating the Safety and Efficacy of InterStim® Therapy in Subjects With Symptoms of Overactive Bladder (InSite OAB)

MedtronicNeuro·interventional·Posted Oct 22, 2007·Updated Dec 12, 2017

In Brief

A Phase 4 clinical trial evaluating InterStim and Standard Medical Therapy for Urinary Incontinence, Urgency-frequency and Overactive Bladder. Completed, enrolled 571 participants.

Detailed Summary

The purposes of this study are: 1. To provide evidence from a randomized controlled trial that InterStim Therapy provides better relief of symptoms of OAB than standard medical treatments in current use. 2. To fulfill the requirements of the FDA-mandated post-approval study of the safety of the tined lead using a minimally invasive approach.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Incontinence, Urgency-frequency, Overactive Bladder
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 22, 2007
Enrollment StartOct 1, 2007
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 18.7 years ago

Interventions

InterStimdevice

Standard Medical Therapydrug

Oxybutynin 2.5mg, 5mg Oxybutynin extended release 5 mg, 10mg, 15mg Oxybutynin transdermal 3.9mg Solifenacin 5mg, 10mg Tolterodine 1mg, 2mg Tolterodine extended release 2mg, 4mg Trospium 20mg Darifenacin extended release 7.5mg, 15mg fesoterodine Fumarate 4mg, 8mg