Effect of Sacral Nerve Stimulation on Enteric Nervous System

Completed

• Conditions: Fecal Incontinence

• Registration Number: NCT01786304
• Lead Sponsor: University Hospital, Rouen

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-05
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-07
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-06
• Last Update Posted: 2016-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of neurons producing vasoactive intestinal peptide (VIP)	6 months	Number of neurons producing vasoactive intestinal peptide (VIP) by immunochemistry

Secondary Outcome Measures

Name	Time	Method
Number of cholinergic neurons	6 months	Number of cholinergic neurons by immunochemistry

Trial Locations

Locations (2)

Rouen University Hospital; 🇫🇷 Rouen, Normandy, France

Nantes University Hospital; 🇫🇷 Nantes, Pays de Loire, France