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

ABSTRACT:

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 Inco

SUBMITTER: Dawoud C 

PROVIDER: S-EPMC12541383 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature