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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01957969
First Posted: October 8, 2013
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Medtronic France SAS
Medtronic MCRI
Information provided by (Responsible Party):
Medtronic International Trading Sarl
  Purpose

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.


Condition Intervention
Fecal Incontinence Device: Sacral Nerve Stimulation

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Months
Official Title: French Post-Inscription Study on Sacral Neuromodulation in the Treatment of Fecal Incontinence

Resource links provided by NLM:


Further study details as provided by Medtronic International Trading Sarl:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Reduction of incontinence episodes per week [ Time Frame: 12 months (9-15 months) ]
  • Reduction of evacuations per week [ Time Frame: 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) ]
  • Retention delay [ Time Frame: 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) ]
  • Fecal Incontinence severity [ Time Frame: 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) ]
  • Patient Satisfaction [ Time Frame: 6 months (5-8 months) and 12 months (9-15 months) ]

Estimated Enrollment: 286
Study Start Date: September 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Principal Population
Patients who undergo a definitive neuro-stimulator implantation.
Device: Sacral Nerve Stimulation
Other Name: INTERSTIM
Annex Population
Patients who do not respond to the temporary test for the neurostimulator implantation
Device: Sacral Nerve Stimulation
Other Name: INTERSTIM

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
French subjects affected by fecal incontinence, indicated to sacral neuromodulation therapy.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01957969


Locations
France
CHU Estaing
Clermont Ferrand, France
CHU Grenoble - Hôpital Michallon
Grenoble, France
CHRU Lille - Hôpital Claude Huriez
Lille, France
CHU Dupuytren
Limoges, France
Hopital Edouard Herriot
Lyon, France
APM Hopital Nord
Marseille, France
CHU Nantes - Hotel Dieu
Nantes, France
GH Diaconesses Croix St Simon
Paris, France
Hôpital Saint Joseph
Paris, France
CHU La Milétrie
Poitiers, France, 86021
CHU Rennes - Hôpital Pontchaillou
Rennes, France
CHU Charles Nicolle
Rouen, France
Polyclinique Pays Basque Sud
St Jean de Luz, France
CHU Hautepierre
Strasbourg, France
CHU Toulouse - Hotel Dieu PURPAN
Toulouse, France
Clinique St Jean du Languedoc
Toulouse, France
Sponsors and Collaborators
Medtronic International Trading Sarl
Medtronic France SAS
Medtronic MCRI
  More Information

Publications:

Responsible Party: Medtronic International Trading Sarl
ClinicalTrials.gov Identifier: NCT01957969     History of Changes
Other Study ID Numbers: 1.05.8004
First Submitted: October 4, 2013
First Posted: October 8, 2013
Last Update Posted: October 18, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases