Artificial sphincter with a new silicone band for treating faecal incontinence: IDEAL 2b prospective multicentre trial.

INTRODUCTION

The management of faecal incontinence (FI) remains challenging and further treatment modalities are urgently needed. The aim of this study was to assess the efficacy of a novel artificial bowel sphincter (SimplyFI anal band), which is implanted around the anal sphincter complex to enhance continence.

METHODS

An exploratory prospective multicentre study based on the IDEAL 2b framework was conducted in patients with FI unresponsive to conservative treatment. Participants underwent SimplyFI implantation, followed by assessments at 1 week and 1, 3, 6, and 12 months after implantation. Intraoperative and postoperative complications were recorded. Functional improvement and quality of life were measured using the St Mark's incontinence score (SMIS) and the Faecal Incontinence Quality of Life Scale (FIQLS).

RESULTS

Eighteen patients were included in the study (17 women, 1 man). The median operating time was 27 (range 13-60) min, with a median hospital stay of 2 (range 1-5) days. One intraoperative complication occurred without affecting the outcome. One patient (5.6%) underwent band removal due to anal discomfort without signs of infection. Relative to baseline, significant improvements were seen at 12 months in median scores for both the SMIS (from 16.5 to 12.5; P = 0.013) and the FIQLS (from 2.0 to 2.6; P = 0.006). Anorectal manometry showed a significant increase in the anal resting pressure from preoperative values to 3 months after implantation (median 15.5 versus 19.0 mmHg, respectively; P = 0.037); however, the increase in anal resting pressure was no longer seen at the 12-month follow-up.

CONCLUSION

In this exploratory study of 18 patients, the SimplyFI anal band appears to be safe with short-term improvement in function. Future studies with longer follow-up periods are needed to better define the role of this new treatment modality. Registration number: NCT05708612 (http://www.clinicaltrials.gov).