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

January 18, 2018 updated by: MedtronicNeuro

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

234

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont Ferrand, France
        • Chu Estaing
      • Grenoble, France
        • CHU Grenoble - Hopital Michallon
      • Lille, France
        • CHRU LILLE - Hôpital Claude Huriez
      • Limoges, France
        • CHU Dupuytren
      • Lyon, France
        • Hôpital Edouard Herriot
      • Marseille, France
        • APM Hopital Nord
      • Nantes, France
        • CHU Nantes - Hôtel Dieu
      • Paris, France
        • Hôpital Saint Joseph
      • Paris, France
        • GH Diaconesses Croix St Simon
      • Poitiers, France, 86021
        • CHU La Miletrie
      • Rennes, France
        • CHU Rennes - Hopital Pontchaillou
      • Rouen, France
        • Chu Charles Nicolle
      • St Jean de Luz, France
        • Polyclinique Pays Basque Sud
      • Strasbourg, France
        • CHU HautePierre
      • Toulouse, France
        • CHU Toulouse - Hotel Dieu PURPAN
      • Toulouse, France
        • Clinique St Jean du Languedoc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

French subjects affected by fecal incontinence, indicated to sacral neuromodulation therapy.

Description

Inclusion Criteria:

  • Patient willing to sign the Data Release Form stating the non opposition to the study conduct;
  • Patient able to understand information given by the investigator in terms of data collection and publication;
  • At least 18 years old or older.
  • Patient indicated to sacral neuromodulation testing with InterStim® system.

Exclusion Criteria:

  • Replacement of an existing sacral neuromodulation system (implanted before inclusion period) without any evidence of benefits during a testing period.
  • Patient unwilling to comply to data collection and publication rules.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Principal Population
Patients who undergo a definitive neuro-stimulator implantation.
Device: Sacral Nerve Stimulation
Other Names:
  • INTERSTIM
Annex Population
Patients who do not respond to the temporary test for the neurostimulator implantation
Device: Sacral Nerve Stimulation
Other Names:
  • INTERSTIM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of implanted patients with a reduction of at least 50% of incontinence episodes per week, compared to baseline.
Time Frame: 6 months (4-8 months)
The primary objective will evaluate the proportion of implanted patients that do not experience any serious adverse event or serious adverse device effect at 4-8 months of follow-up and show a reduction of at least 50% of incontinence episodes per week at the same timeframe, compared to baseline.
6 months (4-8 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction of incontinence episodes per week
Time Frame: 12 months (9-15 months)
12 months (9-15 months)
Reduction of evacuations per week
Time Frame: 6 months (4-8 months) and 12 months (9-15 months)
6 months (4-8 months) and 12 months (9-15 months)
Reduction of urgency episodes per week
Time Frame: 6 months (4-8 months) and 12 months (9-15 months)
6 months (4-8 months) and 12 months (9-15 months)
Retention delay
Time Frame: 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)
3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)
Complications and Adverse Events
Time Frame: 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)
3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)
Fecal Incontinence severity
Time Frame: 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)
3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)
Quality of Life
Time Frame: 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)
3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months)
Patient Satisfaction
Time Frame: 6 months (5-8 months) and 12 months (9-15 months)
6 months (5-8 months) and 12 months (9-15 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedtronicNeuro

Collaborators

Medtronic France SAS
Medtronic MCRI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

October 4, 2013

First Submitted That Met QC Criteria

October 4, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.05.8004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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