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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Medtronic International Trading Sarl
Sponsor:
Collaborators:
Medtronic France SAS
Medtronic MCRI
Information provided by (Responsible Party):
Medtronic International Trading Sarl
ClinicalTrials.gov Identifier:
NCT01957969
First received: October 4, 2013
Last updated: June 3, 2015
Last verified: June 2015
  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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
  • Reduction of evacuations per week [ Time Frame: 6 months (4-8 months) and 12 months (9-15 months) ] [ Designated as safety issue: No ]
  • Reduction of urgency episodes per week [ Time Frame: 6 months (4-8 months) and 12 months (9-15 months) ] [ Designated as safety issue: No ]
  • Retention delay [ Time Frame: 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months) ] [ Designated as safety issue: No ]
  • Complications and Adverse Events [ Time Frame: 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months) ] [ Designated as safety issue: Yes ]
  • Fecal Incontinence severity [ Time Frame: 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months) ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 3 months (1-4 months), 6 months (5-8 months), 12 months (9-15 months) ] [ Designated as safety issue: No ]
  • Patient Satisfaction [ Time Frame: 6 months (5-8 months) and 12 months (9-15 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 286
Study Start Date: September 2013
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: July 2018 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01957969

Contacts
Contact: Claudia Campo claudia.campo@medtronic.com

Locations
France
Hôpital Saint André Not yet recruiting
Bordeaux, France
Contact: Frank Zerbib       frank.zerbib@chu-bordeaux.fr   
Principal Investigator: Frank Zerbib         
CHU Estaing Recruiting
Clermont Ferrand, France
Contact: Anne Dubois       anne.dubois9@orange.fr   
Principal Investigator: Anne Dubois         
CHU Grenoble - Hôpital Michallon Recruiting
Grenoble, France
Contact: Jean-Luc Faucheron       JLFaucheron@chu-grenoble.fr   
Principal Investigator: Jean-Luc Faucheron         
Polyclinique du Maine Not yet recruiting
Laval, France, 53010
Contact: Michel Peyrot, MD       michel.f.peyrot@wanadoo.fr   
Principal Investigator: Michel Peyrot, Dr         
CHRU Lille - Hôpital Claude Huriez Recruiting
Lille, France
Contact: Philippe Zerbib       philippe.zerbib@chru-lille.fr   
Principal Investigator: Philippe Zerbib         
CHU Dupuytren Recruiting
Limoges, France
Contact: Muriel Mathonnet       mathonnet@unilim.fr   
Principal Investigator: Muriel Mathonnet         
Hopital Edouard Herriot Recruiting
Lyon, France
Contact: Henri Damon       henri.damon@chu-lyon.fr   
Principal Investigator: Henri Damon         
Sub-Investigator: Xavier Barth         
Sub-Investigator: François Mion         
Sub-Investigator: Aurélien Garros         
Sub-Investigator: Sabine Roman         
Sub-Investigator: Filbert Djeudji         
APM Hopital Nord Recruiting
Marseille, France
Contact: Pierre Orsoni       pierre.orsoni@ap-hm.fr   
Principal Investigator: Pierre Orsoni         
Sub-Investigator: Carine Visée         
CHU Nantes - Hotel Dieu Recruiting
Nantes, France
Contact: Paul Antoine Lehur       paulantoine.lehur@chu-nantes.fr   
Principal Investigator: Paul Antoine Lehur         
Sub-Investigator: Guillaume Meurette         
APHP Saint Antoine Recruiting
Paris, France, 75012
Contact: Yann Parc, Pr.       Yann.parc@sat.aphp.fr   
Principal Investigator: Yann Parc, Pr.         
GH Diaconesses Croix St Simon Recruiting
Paris, France
Contact: Isabelle Etienney       etienney.i@orange.fr   
Principal Investigator: Isabelle Etienney         
Sub-Investigator: Christian Thomas         
Hôpital Saint Joseph Recruiting
Paris, France
Contact: Jérôme Loriau       jloriau@gmail.com   
Principal Investigator: Jérôme Loriau         
Sub-Investigator: Hélène Pillant-Le Moult         
CHU La Milétrie Recruiting
Poitiers, France, 86021
Contact: Marie-Line Barussaud       Marie-Line.BARUSSAUD@chu-poitiers.fr   
Principal Investigator: Marie-Line Barussaud         
CHU Rennes - Hôpital Pontchaillou Recruiting
Rennes, France
Contact: Laurent Siproudhis       laurent.siproudhis@chu-rennes.fr   
Principal Investigator: Laurent Siproudhis         
Sub-Investigator: Véronique Desfourneaux         
Sub-Investigator: Sylvain Garnier         
Sub-Investigator: Yann Mouchel         
CHU Charles Nicolle Recruiting
Rouen, France
Contact: Anne-Marie Leroi       anne-marie.leroi@chu-rouen.fr   
Principal Investigator: Anne-Marie Leroi Leroi         
Sub-Investigator: Valérie Bridoux         
Polyclinique Pays Basque Sud Recruiting
St Jean de Luz, France
Contact: Michel Escartin       gastro.escartin@pcbs.fr   
Principal Investigator: Michel Escartin         
CHU Hautepierre Recruiting
Strasbourg, France
Contact: Serge Rohr       Serge.Rohr@chru-strasbourg.fr   
Principal Investigator: Serge Rohr         
CHU Toulouse - Hotel Dieu PURPAN Recruiting
Toulouse, France
Contact: Guillaume Portier       portier.g@chu-toulouse.fr   
Principal Investigator: Guillaume Portier         
Clinique St Jean du Languedoc Not yet recruiting
Toulouse, France
Contact: Jean-François Gravié       gravie.jf@wanadoo.fr   
Principal Investigator: Jean-François Gravié         
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
Study First Received: October 4, 2013
Last Updated: June 3, 2015
Health Authority: France: Haute Autorité de Santé Transparency Commission
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: The Commission nationale de l’informatique et des libertés

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

ClinicalTrials.gov processed this record on July 05, 2015