Brain activation in fecal storage, defecation and fecal incontinence: an fMRI study in healthy volunteers, fecal incontinent patients and sacral neuromodulatio

Recruiting

Conditions: fecal incontinence
10002112

Registration Number: NL-OMON54511

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Volunteers
- male or female
- age: 18-70 years
- fecal continent
- able to understand and sign informed consent

Patients
- male or female
- age: 18-70 years
- fecal incontinent
- able to understand and sign informed consent
- eligible for sacral neuromodulation

Exclusion Criteria

General exclusion criteria
- Neurological illnesses, affecting the central nervous system and/or brain
- Psychiatric illnesses: i.e. claustrophobia, schizofrenia
- Inflammatory bowel disease: Crohn*s disease, colitis ulcerosa
- History of constipation, or colorectal cancer
- Anal fissures/fistula
- The use of anti-depressives, anti-epileptics, sleep medication, morphine -
like medication
- Narcotic/alcohol abuse
- Kidney failure
- Pregnancy

MRI exclusion criteria
- Any medical implant (except those that are MR safe or MR conditional)
- Retained wires to the body (e.g. temporary pacing);
- Susceptible to cardiac collapse
- Increased risk of heart attack or other cardiac problems
- Cardiac arrhythmias;
- Impaired thermoregulation;
- Morbidly obese;
- Nauseated (aspiration risk)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter: BOLD -signal intensity<br /><br><br /><br>The BOLD-signal intensity between fecal incontinent patients and healthy<br /><br>volunteers during rectal filling and induction of fecal urgency will be<br /><br>compared.</p><br>

Secondary Outcome Measures