Fecal IncontinenceENS-3NCT01786304
Effect of Sacral Nerve Stimulation on Enteric Nervous System
A study testing Sacral nerve stimulation in people with Fecal Incontinence, run by University Hospital, Rouen at 2 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Sacral nerve stimulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2013to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fecal incotinence
- refractory to medial treatment
- Eligible to a treatment with sacral nerve stimulation
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Nantes University Hospital
Nantes, Pays de Loire, 44000
Rouen University Hospital
Rouen, Normandy, 76000
About this study
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.
Read the 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.
- Conditions
- Fecal Incontinence
- Being tested
- Sacral nerve stimulation
- Keywords
- Fecal incontinence, sacral nerve stimulation
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral nerve stimulationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Fecal incontinence | Experimental | Patient with fecal incontinence and referred for a treatment with sacral nerve stimulation Receives: Procedure: Sacral nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of neurons producing vasoactive intestinal peptide (VIP)
Number of neurons producing vasoactive intestinal peptide (VIP) by immunochemistry
Measured: 6 months
Secondary outcomes (1)
Number of cholinergic neurons
Number of cholinergic neurons by immunochemistry
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- Nantes University Hospital
- Responsible party
- Sponsor
- Investigators
- Guillaume Gourcerol, MD, PhD, Principal investigator, Rouen University Hospital, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786304
- Sponsor's protocol ID
- 2012/091/HP
- Other IDs
- 2012-A00602-41
- Acronym
- ENS-3
- Status last verified
- Jun 2026
- First submitted
- 5 Feb 2013
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sacral Nerve Stimulation on Enteric Nervous System
- ClinicalTrials.gov ID
- NCT01786304
- Acronym / sponsor ID
- ENS-3 / 2012/091/HP
- Conditions
- Fecal Incontinence
- Keywords
- Fecal incontinence, sacral nerve stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- Nantes University Hospital
- Study start
- Jan 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecal incontinence | Experimental | Procedure: Sacral nerve stimulationPatient with fecal incontinence and referred for a treatment with sacral nerve stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fecal incotinence
- refractory to medial treatment
- Eligible to a treatment with sacral nerve stimulation
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacral nerve stimulationimplantation 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 | Procedure or surgery | Fecal incontinence |
Primary outcome
Number of neurons producing vasoactive intestinal peptide (VIP)
Time frame: 6 months
Number of neurons producing vasoactive intestinal peptide (VIP) by immunochemistry
1 secondary outcome
Number of cholinergic neurons
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Gourcerol, MD, PhD principal investigator
Rouen University Hospital, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacral nerve stimulation in people with Fecal Incontinence, run by University Hospital, Rouen at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of neurons producing vasoactive intestinal peptide (VIP) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.