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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 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: NA
Last verified: October 2013
History: No changes posted
  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
Fecal Incontinence

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 Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
  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

Locations
France
Polyclinique du Maine Recruiting
Laval, France, 53010
Contact: Michel Peyrot, MD       michel.f.peyrot@wanadoo.fr   
Principal Investigator: Michel Peyrot, Dr         
APHP Saint Antoine Recruiting
Paris, France, 75012
Contact: Yann Parc, Pr.       Yann.parc@sat.aphp.fr   
Principal Investigator: Yann Parc, Pr.         
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: October 4, 2013
Health Authority: France: Haute Autorité de la Santé
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
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 23, 2014