Overview

This trial has been completed.

Condition fecal incontinence
Treatment sacral nerve stimulation
Sponsor University Hospital, Rouen
Collaborator Nantes University Hospital
Start date January 2013
End date November 2016
Trial size 37 participants
Trial identifier NCT01786304, 2012/091/HP

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patient with fecal incontinence and referred for a treatment with sacral nerve stimulation
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

Primary Outcomes

Measure
Number of neurons producing vasoactive intestinal peptide (VIP)
time frame: 6 months

Secondary Outcomes

Measure
Number of cholinergic neurons
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Effect of Sacral Nerve Stimulation on Enteric Nervous System
Principal investigator Guillaume Gourcerol, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by University Hospital, Rouen.