Effect of Sacral Nerve Stimulation on Enteric Nervous System (ENS-3)

December 6, 2016 updated by: University Hospital, Rouen
Sacral nerve stimulation (SNS) is a new therapeutic option to treat fecal incontinence, although its mecanims of action remains poorly understood. The investigators hypothtized that SNS could act on enteric nervous system (ENS). To verify this hypothesis, the investigators will collect biopsy samples from patients implanted for SNS, and assess whether SNS induces changes in ENS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sacral nerve stimulation (SNS) is a new therapeutic option to treat fecal incontinence. Its efficacy yields 80% approximately, but its mecanims of action remains poorly understood. In particular, SNS does not restore anal squeezing contraction nor it increase anal tone. Recently, using a porcine model, it was shown that SNS changed colonic permeability, suggesting that SNS may activate the enteric nervous system (ENS).

The investigators hypothtized therefore that SNS could act on enteric nervous system (ENS).

To verify this hypothesis, the investigators will collect biopsy samples from patients before and after implantation for SNS. The investigators will assess whether SNS induces changes in ENS, and if this is correlated to SNS efficacy.

Study Type

Observational

Enrollment (Actual)

37

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
    • Normandy
      • Rouen, Normandy, France, 76000
        • Rouen University Hospital
    • Pays de Loire
      • Nantes, Pays de Loire, France, 44000
        • Nantes University Hospital

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with fecal incontience refractory to standard medical treatment

Description

Inclusion Criteria:

  • Fecal incotinence
  • refractory to medial treatment
  • Eligible to a treatment with sacral nerve stimulation

Exclusion Criteria:

  • age < 18 yo
  • age < 75 yo
  • anal defect > 120°
  • bilateral interruption of the bulbo-cavernous reflex
  • patient not able to speack and understand the French Language
  • patient not affilated to the French healthcare system
  • pregnancy

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
Fecal incontinence
Patient with fecal incontinence and referred for a treatment with sacral nerve stimulation
Procedure: Sacral nerve stimulation
implantation of a stimulation electrode in one of the S2-S3-S4 sacral hole then connected to a subcutaneous stimulator for permanent stimulation of the sacral nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of neurons producing vasoactive intestinal peptide (VIP)
Time Frame: 6 months
Number of neurons producing vasoactive intestinal peptide (VIP) by immunochemistry
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of cholinergic neurons
Time Frame: 6 months
Number of cholinergic neurons by immunochemistry
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal incontinence score
Time Frame: 6 months
Measured using the Cleveland Clinic score
6 months
Quality of life
Time Frame: 6 months
measured using the FIQL score that has been validated in french
6 months

Collaborators and Investigators

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

Sponsor

University Hospital, Rouen

Collaborators

Nantes University Hospital

Investigators

  • Principal Investigator: Guillaume Gourcerol, MD, PhD, Rouen University Hospital, France

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

January 1, 2013

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

February 5, 2013

First Submitted That Met QC Criteria

February 6, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Estimate)

December 7, 2016

Last Update Submitted That Met QC Criteria

December 6, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/091/HP

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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