Faecal incontinence Signs and Symptoms Faecal incontinence
Conditions
Interventions
Current interventions as of 19/04/2012:
Participants from up to 20 UK centres providing specialist nurse-led treatment for pelvic floor disorders will be randomised by a computer-based tool to receiv
Sponsors
Queen Mary, University of London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 19/04/2012: Participants aged more than 18 years with faecal incontinence who have failed conservative treatments and whose symptoms are sufficiently severe to merit further intervention, as determined by the Principal Investigator at each centre. Previous inclusion criteria: 1. All patients over the age of 18 years, who have faecal incontinence symptoms sufficiently severe to warrant intervention 2. Who have failed appropriate conservative therapies It is expected that many patients will have had National Institute for Health and Clinical Excellence (NICE)-recommended appropriate specialist investigations including structural and functional anorectal assessment although these are not mandatory. Anal sphincter injury is not a contra-indication.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 19/04/2012: 1. Inability to provide informed consent for the research study 2. Inability to fill in the detailed bowel diaries required for outcome assessments 3. Neurological diseases, such as diabetic neuropathy, multiple sclerosis, and Parkinson's disease (any participant with painful peripheral neuropathy) 4. Anatomical limitations that would prevent successful placement of needle electrode 5. Other medical conditions precluding stimulation - e.g., bleeding disorders, certain cardiac pacemakers, peripheral vascular disease or ulcer, lower leg cellulitis 6. Congenital anorectal anomalies or absence of native rectum due to surgery 7. A cloacal defect 8. Present evidence of external full thickness rectal prolapse 9. Previous rectal surgery (rectopexy / resection) done <12 months ago (24 months for cancer) 10. Stoma in situ 11. Chronic bowel diseases such as inflammatory bowel disease leading to chronic uncontrolled diarrhoea 12. Pregnancy or intention to become pregnant 13. Previous experience of sacral nerve stimulation or PTNS Previous exclusion criteria: 1. Inability to provide informed consent for the research study 2. Inability to fill in the detailed bowel diaries required for outcome assessments (this will exclude patients who do not speak / read English) 3. Neurological diseases, such as diabetic neuropathy, multiple sclerosis and Parkinson's disease (any patient with painful peripheral neuropathy) 4. Anatomical limitations that would prevent successful placement of needle electrode 5. Other medical conditions precluding stimulation: e.g. bleeding disorders, certain cardiac pacemakers, peripheral vascular disease 6. Congenital anorectal anomalies or absence of native rectum due to surgery 7. Present evidence of external full thickness rectal prolapse 8. Previous rectal surgery (rectopexy/resection) done < 12 months ago (24 months for cancer) 9. Stoma in situ 10. Chronic bowel diseases such as inflammatory bowel disease leading to chronic uncontrolled diarrhoea 11. Pregnancy or intention to become pregnant 12. Previous experience of SNS or PTNS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure(s) as of 19/04/2012: The primary outcome is the proportion of patients achieving = 50% reduction in faecal incontinence episodes per week. Previous primary outcome measure(s): Change in weekly FI episodes expressed as proportion of patients achieving more than or equal to 50% reduction in FI episodes per week. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure(s) as of 19/04/2012: 1. Percentage change in episodes of faecal incontinence per week 2. Numeric continuous change in episodes of faecal incontinence per week 3. Cleveland Clinic Faecal Incontinence Score 4. Patient Centred Outcomes Form 5. Likert scale of patients' global impression of success 6. Disease-specific and generic quality of life measures (EQ-5D Health Questionnaire, SF-36, GI Quality of Life Index, Quality of Life Scale for Faecal Incontinence) 7. Short urinary symptom assessment by interview before and after the intervention. Previous secondary outcome measure(s): 1. Percentage change FI episodes per week 2. Numeric continuous change in FI episodes per week 3. Validated incontinence scores 4. Patient-centred FI-related symptoms 5. Likert scale of patients global impression of success 6. Disease specific and generic quality of life measures 7. Short urinary symptom assessment All measurements will be taken prior to commencement of the PTNS treatment and on the visit following the final treatment. | — |
Countries
United Kingdom
Outcome results
None listed