Skip to main content
OpenTrials
Completed

NCT Number: NCT01786304

Effect of Sacral Nerve Stimulation on Enteric Nervous System

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rouen University Hospital, Rouen, Normandy, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sacral nerve stimulation

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

Primary outcomes

  1. Number of neurons producing vasoactive intestinal peptide (VIP)

    Time frame: 6 months

    Number of neurons producing vasoactive intestinal peptide (VIP) by immunochemistry

Secondary outcomes

  1. Number of cholinergic neurons

    Time frame: 6 months

    Number of cholinergic neurons by immunochemistry

Other outcomes

  1. Fecal incontinence score

    Time frame: 6 months

    Measured using the Cleveland Clinic score

  2. Quality of life

    Time frame: 6 months

    measured using the FIQL score that has been validated in french

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Collaborators

  • Nantes University Hospital

Registry information

Acronym: ENS-3

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 7, 2013
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.