Effect of Sacral Nerve Stimulation on Enteric Nervous System
ENS-3
1 other identifier
observational
37
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2013
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 5, 2013
CompletedFirst Posted
Study publicly available on registry
February 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedDecember 7, 2016
December 1, 2016
3.8 years
February 5, 2013
December 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of neurons producing vasoactive intestinal peptide (VIP)
Number of neurons producing vasoactive intestinal peptide (VIP) by immunochemistry
6 months
Secondary Outcomes (1)
Number of cholinergic neurons
6 months
Other Outcomes (2)
Fecal incontinence score
6 months
Quality of life
6 months
Study Arms (1)
Fecal incontinence
Patient with fecal incontinence and referred for a treatment with sacral nerve stimulation
Interventions
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
Eligibility Criteria
Patient with fecal incontience refractory to standard medical treatment
You may qualify if:
- Fecal incotinence
- refractory to medial treatment
- Eligible to a treatment with sacral nerve stimulation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Rouenlead
- Nantes University Hospitalcollaborator
Study Sites (2)
Rouen University Hospital
Rouen, Normandy, 76000, France
Nantes University Hospital
Nantes, Pays de Loire, 44000, France
Biospecimen
colonic biopsies
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guillaume Gourcerol, MD, PhD
Rouen University Hospital, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2013
First Posted
February 7, 2013
Study Start
January 1, 2013
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
December 7, 2016
Record last verified: 2016-12