Effect of Sacral Nerve Stimulation on Enteric Nervous System

Fecal Incontinence Clinical Trial

— ENS-3  

Official title:

Effect of Sacral Nerve Stimulation on Enteric Nervous System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01786304
• Other study ID #: 2012/091/HP
• Status: Completed
• Phase: N/A
• First received: February 5, 2013
• Last updated: December 6, 2016
• Start date: January 2013
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes	Pays de Loire
France	Rouen University Hospital	Rouen	Normandy

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Rouen	Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fecal incontinence score	Measured using the Cleveland Clinic score	6 months	No
Other	Quality of life	measured using the FIQL score that has been validated in french	6 months	No
Primary	Number of neurons producing vasoactive intestinal peptide (VIP)	Number of neurons producing vasoactive intestinal peptide (VIP) by immunochemistry	6 months	No
Secondary	Number of cholinergic neurons	Number of cholinergic neurons by immunochemistry	6 months	No