Effect of Sacral Nerve Stimulation on Enteric Nervous System

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01786304

Acronym

ENS-3

Enrollment

Registered

2013-02-07

Start date

2013-01-01

Completion date

2016-11-01

Last updated

2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fecal Incontinence

Keywords

Fecal incontinence, sacral nerve stimulation

Brief summary

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

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.

Interventions

PROCEDURESacral 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Number of cholinergic neurons	6 months	Number of cholinergic neurons by immunochemistry

Countries

France

Contacts

PRINCIPAL_INVESTIGATORGuillaume Gourcerol, MD, PhD

Rouen University Hospital, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 4, 2026