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Effect of Sacral Nerve Stimulation on Enteric Nervous System

NCT ID: NCT01786304

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fecal Incontinence

Keywords

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Fecal incontinence, sacral nerve stimulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fecal incontinence

Patient with fecal incontinence and referred for a treatment with sacral nerve stimulation

Sacral nerve stimulation

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role collaborator

University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume Gourcerol, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rouen University Hospital, France

Locations

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Rouen University Hospital

Rouen, Normandy, France

Site Status

Nantes University Hospital

Nantes, Pays de Loire, France

Site Status

Countries

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France

Other Identifiers

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2012/091/HP

Identifier Type: -

Identifier Source: org_study_id