Central brain responses of sacral nerve stimulation in patients with faecal incontinence

Not Applicable

Active, not recruiting

• Conditions: Faecal incontinence; Functional bowel disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Neurological - Studies of the normal brain and nervous system

• Registration Number: ACTRN12615001334594
• Lead Sponsor: Professor Marc Gladman

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Age >18 years
2. Predominant symptom: Faecal Incontinence
3. Have no contraindications to MRI
4. Participants already scheduled to be treated by sacral nerve stimulation

Exclusion Criteria

1. Non-English speaking
2. Cognitive impairment
3. CI to MRI e.g. claustrophobia
4. Major Psychological Disorders (eg. Major Depression, Major Anxiety, Schizophrenia, Bipolar)
4. Pregnancy
5. Neurological disorders e.g. Spina Bifida, Multiple Sclerosis, Parkinson disease.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in brain activity with the device switched on, as assessed using functional MRI [At baseline and 6 weeks post implantation of sacral nerve stimulator]

Secondary Outcome Measures

Name	Time	Method
Changes in resting state brain activity, assessed by fMRI [At baseline and 6 weeks post implantation of device]