Electrical therapy for faecal incontinence in children with spina bifida

Phase 2

• Conditions: Faecal incontinence; Spina bifida; Human Genetics and Inherited Disorders - Other human genetics and inherited disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Neurological - Other neurological disorders

• Registration Number: ACTRN12614001011673
• Lead Sponsor: Murdoch Childrens Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

*Presenting with spina bifida aperta or open neural tube defect (i.e. myelomeningocele, meningocele or myeloschisis);
*Aged between 8 and 18 years old at the time of screening;
*Faecal incontinence reported for the last 6 months,
*Failed management of faecal incontinence with retrograde continence enema,
*Ability to answer questionnaires and complete the diary, with parental assistance if necessary.

Exclusion Criteria

*Has a heart pacemaker or a cochlear implant;
*Has abnormal abdominal sensation
*Presents symptoms or signs of bowel obstruction;
*Has cancer;
*Is pregnant (pregnancy test planned before TES);
*Has had a previous diagnosis of a metabolic or hormonal disorder; and,
*Non English speaking.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of faecal incontinence (based on the bowel diaries). The bowel diaries will record frequency of bowel movements, time spent for defecation, need for help for evacuation (digital stimulation, laxatives, enemas), feeling of completeness of evacuation, associated pain, frequency of faecal incontinence, incontinence for solid or liquid stool, incontinence for gas, need to wear a pad or a plug. It is a composite primary outcome: this will allow us to obtain a score of faecal incontinence (St-Marks faecal incontinence score). [Daily diaries will be completed by the participant during a two times two-week period, during the 2 months of baseline measurements and then during the 2 months of the intervention (stimulation), .]

Secondary Outcome Measures

Name	Time	Method
Quality of life (assessed by the FICQOL questionnaire)<br><br>[Before intervention (baseline) and on completion of the 2-month intervention period];Colonic transit time (evaluation by radiopaque markers)[Before intervention and on completion of the 2-month intervention period]