Are micro enemas administered with a squeeze tube and a 5 cm-long nozzle as good or better than micro enemas administered with a 10 cm-long catheter attached to a syringe in people with a recent spinal cord injury? A non-inferiority, crossover randomised controlled trial

Abstract

Abstract Study design Double blind, non-inferiority crossover randomised controlled trial. Objectives To determine if micro enemas administered with a squeeze-tube and a 5 cm-long nozzle (squeeze-tube method) are as good or better than micro enemas administered with a 10 cm-long catheter attached to a syringe (catheter method) in people with a recent spinal cord injury. Setting Two inpatient spinal cord injury units located in Sydney, Australia. Methods Twenty people admitted to hospital with recent spinal cord injury were randomly assigned to two treatment sequences; 4 weeks of micro enemas delivered by the squeeze-tube method followed by 4 weeks of micro enemas delivered by the catheter method, or vice versa. Each treatment sequence was 8 weeks with a crossover at the end of week 4. The primary outcome was time to complete bowel care. Secondary outcomes reflected faecal incontinence, quality of life, perception of treatment effectiveness and participant reported time to complete bowel care. The primary and secondary outcomes were measured by blinded assessors in week 4 and week 8. A non-inferiority margin of 10 min for time to complete bowel care was set a priori. Results The mean between group difference (95% confidence interval) for the time to complete bowel care was −0.5 min (−2.8 to 1.8), where a negative value favours the catheter method. Results were similar for all secondary outcomes. Conclusions Micro enemas delivered by the squeeze-tube method are as good or better than micro enemas delivered by the catheter method in people with a recent spinal cord injury.