Passive faecal incontinence Signs and Symptoms Faecal incontinence
Conditions
Interventions
Injectable bulking agents to augment the bulk of the internal anal sphincter: injectable silicone biomaterial (PTQTM) vs carbon-coated beads (Durasphere®).
Sponsors
Epworth Hospital, University of Melbourne (Australia)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, no age limits 2. Faecal seepage or soiling for more than twice a week caused by internal sphincter (IAS) dysfunction 3. Not responding to treatment with dedicated pelvic floor exercises and stool bulking agents
Exclusion criteria
Exclusion criteria: 1. Perianal sepsis 2. Anorectal cancer 3. Immunosuppression 4. Rectal prolapse 5. Inflammatory bowel disease 6. Congenital anorectal malformation 7. Neurological disorders such as Parkinson?s disease 8. Multiple sclerosis 9. Spinal-cord injury 10. Stoma in situ 11. Pregnancy 12. External anal sphincter defect of more than 120º of the circumference 13. Bleeding diathesis, 14. Mental or physical disability precluding adherence to study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wexner?s continence score, assessed at 2 and 6 weeks, then 6 and 12 months after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| The following were assessed at 2 and 6 weeks, then 6 and 12 months after treatment: 1. Faecal incontinence quality of life (FIQL) scale 2. Short Form 12 (SF-12) health survey questionnaire 3. Adverse events | — |
Countries
Australia
Outcome results
None listed