Faecal incontinence in adults Digestive System Faecal incontinence
Conditions
Interventions
Two interventional arms:
1. Sacral nerve stimulation
2. Anal bulking therapy
Sponsors
Sahlgrenska University Hospital (Sweden)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with fecal incontinence with > or = 2 episodes of fecal incontinence/week. 2. > 18 years 3. Insufficient effect of conservative treatment (physiotherphy, diet, drugs). 4. At least one year duration of symptoms 5. At least one year after vaginal delivery 6. Ability to confirm informed consent
Exclusion criteria
Exclusion criteria: 1. Complete external sphincter defect (at least 90 degrees, whole length of the anal canal evaluated by physical examination of ultrasound). 2. Ongoing anorectal infection 3. Active inflammatory bowel disease 4. Anorectal implant. 5. Anorectal surgery within the last 12 months. 6. Mucosal prolaps (gr 3-4) 7. Rectal prolaps 8. Ongoing malignant disease 9. Ongoing immunosuppressive treatment 10. Treatment with warfarin 11. Rectal anastomosis 12. Neurologic disease (MS, ALS, Myelomeningocele etc.) 13. Previous pelvic radiotherphy 14. Ongoing anorectal pain 15. Included in other RCT 16. Pregnancy 17. Previously treated with any of the two alternatives in the study 18. Concurrent condition or disease that makes the person unsutable for the study according clinical jugement of the investigator (eg not likely to follow the study protocol).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responding (> 50% reduction of the number of fecal incontinence episodes compared to baseline) proportion after one year after randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in number of faecal incontinence episodes 2. Change in deferring time 3. Change in incontinence score 4. Change in Quality of Life 5. Adverse events | — |
Countries
Sweden
Outcome results
None listed