ISRCTN98760715Completed未知
SUBsensory Sacral Neuromodulation for InContinence: Randomised double-blind efficacy and mechanism study of sub-sensory sacral (optimised) neuromodulation in adults with faecal incontinence
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Enrollment
- 39
Study Overview
Brief Summary
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29941019 protocol
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
- •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 < 12 months ago (24 months for cancer)
- •4. Present evidence or past history of full thickness rectal prolapse
- •5. Prior diagnosis of chronic inflammatory bowel diseases
- •6. Displays symptoms of chronic constipation with over-flow incontinence
- •7. Structural abnormality of the pelvic floor leading to clear evidence of obstructed defaecation based on examination and/or imaging
- •8. Symptoms of significant evacuatory dysfunction based on Obstructive Defecation Syndrome Score > = 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.
Investigators
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