CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 234 enrolled
Drug / intervention
Sacral Nerve Stimulationdevice
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.

Search/NCT01957969
NCT01957969N/ACompleted

French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence

MedtronicNeuro·observational·Posted Oct 8, 2013·Updated Jan 23, 2018

In Brief

An observational study evaluating Sacral Nerve Stimulation for Fecal Incontinence. Completed, enrolled 234 participants across 16 sites.

Detailed Summary

The aim of this observational study is to evaluate the utilization in the clinical practice, effectiveness, explantation and re-intervention rate, complications and adverse events of InterStim system in patients indicated to Sacral Neuromodulation therapy for fecal incontinence. This study will provide additional data about safety and effectiveness of the usage of InterStim system in fecal incontinence environment and at the same time will confirm that results from clinical trials can be transposed to clinical practice.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 8, 2013
Enrollment StartSep 1, 2013
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 12.7 years ago

Interventions

Sacral Nerve Stimulationdevice