Subsensory sacral neuromodulation for incontinence

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 39

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.