Insertion of a magnetic bead band for faecal incontinence

4 Efficacy

This section describes efficacy outcomes from the published literature that the Committee considered as part of the evidence about this procedure. There was considerable patient overlap between the studies. For more detailed information on the evidence, see the interventional procedure overview.

4.1 A non-randomised comparative study of 28 patients treated by insertion of a magnetic bead band or sacral nerve stimulation reported improved median continence scores in both groups from 16.5 and 15 at baseline to 6 and 11.5 (p=0.001 and 0.0001) respectively at follow-up (median follow-up 18 and 22 months respectively). A non-randomised comparative study of 20 patients treated by insertion of a magnetic bead band or artificial bowel sphincter reported improved median continence scores in both groups from 17 and 16.5 at baseline to 6 and 5 (p=0.0002 and 0.0001) respectively at follow-up (median follow-up 8 and 22.5 months respectively).

4.2 The non-randomised comparative study of 28 patients reported statistically significant improvements from baseline in mean quality-of-life scores at follow-up for all 4 domains (lifestyle, coping/behaviour, depression and embarrassment) in both groups (median follow-up 18 and 22 months respectively). The non-randomised comparative study of 20 patients reported statistically significant improvements in median quality-of-life scores in both groups from 1.9 and 1.8 at baseline to 3.4 and 3.6 (p=0.005 and 0.009) respectively at follow-up (median follow-up 8 and 22.5 months respectively).

4.3 A case series of 24 patients reported that 70% (16/23) of patients were satisfied with the procedure and 61% (14/23) would recommend it to another person. A case series of 14 patients reported that 1 patient chose to have the magnetic bead band removed after 69 days because it did not meet her expectations: she opted for a stoma for personal reasons.

4.4 The specialist advisers stated that the key efficacy outcome is improved continence with accompanying improvement in disease-specific and generic quality of life.