NCT00213317

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2005

Typical duration for all trials

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

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

February 16, 2012

Status Verified

February 1, 2012

Enrollment Period

3.2 years

First QC Date

September 13, 2005

Last Update Submit

February 14, 2012

Conditions

Functional Colonic DiseaseFecal Incontinence

Keywords

sacral magnetic stimulationfecal incontinenceconstipation

Interventions

lombo-sacral magnetic stimulationPROCEDURE

repetitive lombo-sacral nerve magnetic stimulation active and placebo performed during colonic recordings after bisacodyl instillation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers without anorectal or neurological disease

You may qualify if:

  • healthy volunteers

You may not qualify if:

  • pregnant women metallic material implanted organic digestive disease neuro-surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colonic Diseases, FunctionalFecal IncontinenceConstipation

Condition Hierarchy (Ancestors)

Colonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesRectal DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anne-Marie LEROI, PHD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

April 1, 2005

Primary Completion

June 1, 2008

Study Completion

August 1, 2008

Last Updated

February 16, 2012

Record last verified: 2012-02