None listed
Conditions
Brief summary
The aim of the study is to determine if transcutaneous electrical stimulation can reduce the severity of persistent faecal incontinence in a group of children with spina bifida previously unsuccessfully treated with retrograde continence enema. Faecal incontinence in children with spina bifida is currently treated by retrograde continence enema. Transcutaneous electrical therapy will be proposed as an alternative therapy to children with spina bifida aged 8-18 who have failed retrograde continence enema treatment. We have not tested transcutaneous electrical stimulation on children with spina bifida. There has been one study using transcutaneous electrical stimulation to treat faecal incontinence in children with spina bifida but there were no quantitative outcome measures that could be used to predict the number of patients needed in a randomized control trial. A baseline period will be followed with a therapy (stimulation) period. Outcomes measurements will be compared before and after stimulation. Outcomes are severity of faecal incontinence, quality of life and colonic transit time.
Interventions
The transcutaneous electrical stimulation (TES) machine is a small device (approximately 20 cm x 30 cm), connected to 240V power source. It has two independent channels of current. We use electrodes that are small sticky pads of 4 cm x 4 cm (pure silicon). The device delivers an interferential current with a carrier frequency of 4 Hz, a beat frequency sweep covering 80 to 160 Hz, with an adjustable intensity less than 33 milliA. Individual pulses have duration of 250 micros (constant alternating
The transcutaneous electrical stimulation (TES) machine is a small device (approximately 20 cm x 30 cm), connected to 240V power source. It has two independent channels of current. We use electrodes that are small sticky pads of 4 cm x 4 cm (pure silicon). The device delivers an interferential current with a carrier frequency of 4 Hz, a beat frequency sweep covering 80 to 160 Hz, with an adjustable intensity less than 33 milliA. Individual pulses have duration of 250 micros (constant alternating current). Two pairs of electrodes are placed on the front and on the back of the inferior abdomen. Stimulation will be delivered daily for 1 hour, either mornings or evenings, for 2 months, at home, by the participant themselves or their carer. Patients will be in contact by phone each week and asked if they have used the TES each day and for how long. TES use will be recorded on the daily bowel diary.
Sponsors
Murdoch Childrens Research Institute
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
8 Years to 18 Years
Healthy volunteers
No
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.
Outcome results
None listed