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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54511

Enrollment

Registered

2019-11-06

Start date

2020-11-11

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fecal incontinence

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Main study parameter: BOLD -signal intensity The BOLD-signal intensity between fecal incontinent patients and healthy volunteers during rectal filling and induction of fecal urgency will be compared.	—

Countries

Netherlands

Outcome results