Faecal incontinence Digestive System
Conditions
Interventions
In contrast to a traditional clinical trial, the design of this trial allows all participants to receive the treatment. This is possible by using a crossover design i.e. one where after implantation o
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18-80 (updated 25/07/2019, previously: 75) 2. Meet Rome III and ICI definitions of FI (recurrent involuntary loss of faecal material that is a social or hygienic problem and not a consequence of an acute diarrhoeal illness) 3. Failure of non-surgical treatments to the NICE standards. Minimum NICE standard includes; diet, bowel habit and toilet access addressed. Medication e.g. loperamide, advice on incontinence products, pelvic floor muscle training, biofeedback and rectal irrigation should be offered if appropriate. 4. Minimum severity criteria of 8 FI episodes in a 4 week screening period (this is important to exclude patients who might thence have zero FI episodes during baseline evaluations) 5. Ability to understand written and spoken English or relevant language in European centres (due to questionnaire validity) 6. Ability and willingness to give informed consent All participants will have been determined as clinically suitable for SNM based on clinical evaluation and subsequent multidisciplinary team discussion (as mandated by NHS England specialist commissioning guidance) or equivalent guidance in other participating EU countries.
Exclusion criteria
Exclusion criteria: A standard list of exclusions (disease variants; surgical fitness, specific contraindications to implantation) will be used. Note that these are routine clinical exclusions to the use of SNM rather than participation in the research. For completion: 1. Known communication between the anal and vaginal tracts 2. Prior diagnosis of congenital anorectal malformations 3. Previous rectal surgery (rectopexy/resection) performed = 8 9. Presence of active perianal sepsis (including pilonidal sinus) 10. Defunctioning loop or end stoma in situ 11. Diagnosed with neurological diseases, such as diabetic neuropathy, multiple sclerosis and Parkinson's disease 12. Current or future need for MR imaging based on clinical history 13. Complete or partial spinal cord injury 14. Bleeding disorders e.g. haemophilia, warfarin therapy 15. Pregnancy or intention to become pregnant during the study period 16. Not fit for preferred method of anaesthesia 17. Anatomical limitations that would prevent successful placement of an electrode including congenital abnormalities 18. Psychiatric or physical inability to comply with the study protocol (inc. e-diary assessments) at investigator discretion 19. Required to drive for long periods of time for example lorry drivers, taxi drivers and delivery drivers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The reduction in FI events in SNM vs. SHAM using a 4 week bowel diary in paper format between 12 and 16 and between 28 and 32 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| A variety of quality of life questionnaire and bowel diary measures recorded at 16, 32 and 58 weeks: 1. E-event recorder including episodes of faecal material, leakage of flatus, urgency without incontinence, social and physical activity (see figure 4 below); 2. Other bowel diary measures: Urgency, Urge and passive faecal incontinence episodes, use of loperamide and social functioning; 3. Summative questionnaire assessments: St Mark’s continence score52; OAB-Q SF score, FI QoL score53; International Consultation on Incontinence Bowel (SF-ICIQ-B) questionnaire54. 4. Viscerosensory bowel diary recording quality, site and intensity of defaecatory urge 5. Generic QOL: EQ-5D-5L 6. Likert scale of patient’s global impression of treatment success (scale 0-10) and patient perception of group allocation (blinding success). 7. Electrode settings (inc. motor, first and habituated sensory thresholds), programming, & if applicable re-programming data 8. Adverse events and morbidity. Mechanistic outcomes 1. Advanced anorectal physiology 2. Anocortical neurophysiology | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactEleanor;Kerry McAlees;Tubby
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Outcome results
None listed