Faecal incontinence (FI) in adults Signs and Symptoms Faecal incontinence
Conditions
Interventions
SNS ? this is a two-stage procedure whereby a temporary percutaneous electrode is used to stimulate the sacral nerves for a period of two weeks, after which the effect on continence is assessed and th
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged = 18 years 2. Able to provide written informed consent 3. FI for more than 6 months 4. Incontinent episodes of = 2 per week 5. Suitable candidate for surgery, as judged by the operating surgeon (suitability assessment includes general fitness and conservative treatments for FI having proved ineffective.) 6. Suitable for either FENIX TM MSA or SNS 7. Anal sphincter defect < 180° as documented on endoanal ultrasound scan 8. Able and willing to comply with the terms of the protocol including Quality of Life (QoL) questionnaires
Exclusion criteria
Exclusion criteria: 1. Previous interventions for FI i.e. SNS, FENIX TM MSA or ABS 2. Chronic gastrointestinal motility disorders causing incontinence due to diarrhoea 3. Obstructed defaecation, as defined by an inability to satisfactorily evacuate the rectum (Obstructed Defecation score(OD-score) >8) 4. Anal sphincter defect = 180°, as documented on endoanal ultrasound scan 5. An electric or metallic implant within 10cm of anal canal 6. Co-existent systemic disease (e.g. scleroderma, etc.) impacting on continence 7. Active anorectal sepsis 8. Diagnosis of colorectal or anal cancer within 2 years 9. External rectal prolapse 10. Significant scarring of the anorectum that, as judged by the treating surgeon, would prohibit FENIX TM MSA implantation or put the patient at high risk of implant erosion 11. Pregnancy (It is the local surgeon?s responsibility to ensure this is assessed in women of child-bearing potential according to local standard of care.) 12. Immunocompromise, including haematological abnormalities and treatment with steroids or other immunomodulatory medicines. 13. Congenital spinal abnormalities, preventing SNS implantation 14. Known requirement for future Magnetic Resonance Imaging (MRI) surveillance, which would be contraindicated in the presence of metallic implant 15. Suspected or known allergies to titanium
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in the percentage of successes, as defined by the device in situ and = 50% improvement in the CCIS (Cleveland Clinic Incontinence Score) between the two treatments at 18 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety of FENIX TM MSA or SNS, as judged by explant rates and operative (including those occurring during theatre-time and post-surgery stay) and post-operative complications (up to and including 12 months from the date of the last study surgery) 2. Change in generic and disease-specific QoL from baseline, as measured by CCIS (Cleveland Clinic Incontinence Score), OD-score (Obstructed Defecation Score), FiQOL (Faecal Incontinence Quality of Life), EQ-5DTM and SF12® at 6, 12 and 18 months post-randomisation 3. Cost-effectiveness, using QALY outcome measures, assessed by EQ-5D, SF12, Health Resource Use Questionnaires and HES (Hospital Episode Statistics) data | — |
Countries
England, United Kingdom
Outcome results
None listed