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Clinical Trials/NCT01786304
NCT01786304
Completed
Not Applicable

Effect of Sacral Nerve Stimulation on Enteric Nervous System

University Hospital, Rouen2 sites in 1 country37 target enrollmentJanuary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fecal Incontinence
Sponsor
University Hospital, Rouen
Enrollment
37
Locations
2
Primary Endpoint
Number of neurons producing vasoactive intestinal peptide (VIP)
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
November 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Rouen
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of neurons producing vasoactive intestinal peptide (VIP)

Time Frame: 6 months

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

Secondary Outcomes

  • Number of cholinergic neurons(6 months)

Study Sites (2)

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