At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 140 target
Drug / intervention
Type: Implantable neurostimulator; InterStimdevice
Likely dose
Not stated in 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.
Sacral Nerve Stimulation for Anal Incontinence and Bowel Control
In Brief
A Phase 4 clinical trial evaluating Type: Implantable neurostimulator; InterStim for Fecal Incontinence and Constipation. Completed, enrolled 140 participants across 9 sites in 8 countries.
Detailed Summary
Multicenter European study to evaluate efficacy and safety of sacral nerve stimulation with InterStim Therapy to treat fecal incontinence or constipation
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFecal Incontinence and Constipation
CountriesAustria, Denmark, Germany, Netherlands, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 4CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 1998
First PostedSep 2005
Primary CompletionDec 2006
Study CompletionSep 2012
TodayJul 2026
First PostedSep 20, 2005
Enrollment StartNov 1, 1998
Primary CompletionDec 1, 2006
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 20.8 years ago
Interventions
Type: Implantable neurostimulator; InterStimdevice
Treatment with InterStim Therapy: all patients meeting inclusion/exclusion criteria undergo test screening and those who have successful outcomes receive a permanent implant.