Pelvipower for Faecal Incontinence
Faecal Incontinence
About this trial
This is an interventional treatment trial for Faecal Incontinence
Eligibility Criteria
Inclusion Criteria: >18 years of age Female Have suffered from faecal incontinence, for >6 months, sufficiently severe enough to warrant intervention . Previous exposure to treatment is not a contraindication to this. Body Mass Index between 18.9 and 40.0kg/m2 (bounds included) >6 months post-natal ≥4 FI episodes during 2 week screening period Exclusion Criteria: Neurological disease which may affect continence (i.e. diabetic neuropathy, multiple sclerosis, Parkinson's disease etc) Thromboses Suffering from or recovering from a serious illness or operation Faecal incontinence secondary to impaction Currently using rectal irrigation Currently undergoing biofeedback therapy Pregnancy Pacemaker in situ Indwelling metal implants Recent skeletomuscular injury or surgery in the last month Congenital anorectal disorders such as cloacal defect Participant has a > grade 2 rectal prolapse Absence of native rectum due to surgery (anterior resection) Previous anal/rectal surgery in the past 12 months Stoma in situ Chronic bowel diseases with chronic uncontrolled diarrhoea Unable to discontinue Loperamide during washout period Severe cardiac arrhythmia Epilepsy
Sites / Locations
- The Functional Gut ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Pelvipower chair
Sham stimulation