NCT01786304

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 3, 2026

Status Verified

June 1, 2026

Enrollment Period

3.8 years

First QC Date

February 5, 2013

Last Update Submit

June 1, 2026

Conditions

Fecal Incontinence

Keywords

Fecal incontinence, sacral nerve stimulation

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

EXPERIMENTAL

Patient with fecal incontinence and referred for a treatment with sacral nerve stimulation

Procedure: Sacral nerve stimulation

Interventions

Sacral nerve stimulationPROCEDURE

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

Fecal incontinence

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (2)

Rouen University Hospital

Rouen, Normandy, 76000, France

Location

Nantes University Hospital

Nantes, Pays de Loire, 44000, France

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Guillaume Gourcerol, MD, PhD

    Rouen University Hospital, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
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

June 3, 2026

Record last verified: 2026-06

Locations

FR(2)