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

NCT01957969 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 234

Last updated 2018-01-23

No results posted yet for this study

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.

Conditions

  • Fecal Incontinence

Interventions

DEVICE

Sacral Nerve Stimulation

Sponsors & Collaborators

  • Medtronic France SAS

    collaborator INDUSTRY

  • Medtronic MCRI

    collaborator UNKNOWN

  • MedtronicNeuro

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01957969 on ClinicalTrials.gov