Functional Colonic DiseaseNCT00213317
Effect of Lumbo-sacral Magnetic Stimulation on Colonic Motility
An observational study of Functional Colonic Disease and Fecal Incontinence, run by University Hospital, Rouen at 1 site in France.
Trial summary
The purpose of this study is to evaluate the effect of sacral nerve magnetic stimulation on the colonic motility in healthy subjects, in incontinent and constipated patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Functional Colonic Disease, Fecal Incontinence
- What is being tested?
- lombo-sacral magnetic stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2005to Aug 2008
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers without anorectal or neurological disease
Who may be able to join
- healthy volunteers
Who cannot join
- pregnant women metallic material implanted organic digestive disease neuro-surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Could Lumbo-sacral Magnetic Stimulation Modify Recto-colonic Motility?
The purpose of this study is to evaluate the effect of sacral nerve magnetic stimulation on the colonic motility in healthy subjects, in incontinent and constipated patients.
- Conditions
- Functional Colonic Disease, Fecal Incontinence
- Being tested
- lombo-sacral magnetic stimulation
- Keywords
- sacral magnetic stimulation, fecal incontinence, constipation
- Medical subject headings
- Colonic Diseases, Functional, Fecal Incontinence, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lombo-sacral magnetic stimulationProcedure or surgery
repetitive lombo-sacral nerve magnetic stimulation active and placebo performed during colonic recordings after bisacodyl instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionJun 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Colonic DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Marie LEROI, PHD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213317
- Sponsor's protocol ID
- 2003/041/HP
- Status last verified
- Feb 2012
- First submitted
- 13 Sep 2005
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could Lumbo-sacral Magnetic Stimulation Modify Recto-colonic Motility?
- ClinicalTrials.gov ID
- NCT00213317
- Acronym / sponsor ID
- 2003/041/HP
- Conditions
- Functional Colonic Disease, Fecal Incontinence
- Keywords
- sacral magnetic stimulation, fecal incontinence, constipation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 21 Sep 2005 (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.
The purpose of this study is to evaluate the effect of sacral nerve magnetic stimulation on the colonic motility in healthy subjects, in incontinent and constipated patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers without anorectal or neurological disease
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (1 listed)
- pregnant women metallic material implanted organic digestive disease neuro-surgery
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 |
|---|---|---|
| lombo-sacral magnetic stimulationrepetitive lombo-sacral nerve magnetic stimulation active and placebo performed during colonic recordings after bisacodyl instillation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 4 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.
Anne-Marie LEROI, PHD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Colonic Disease and Fecal Incontinence, run by University Hospital, Rouen at 1 site 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 1 inclusion and 1 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 4 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 1 site 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.
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 4 Jun 2026.