Clinical efficacy of subsensory sacral neuromodulation in adults with faecal incontinence: The SUBSoNIC crossover randomised controlled trial and cohort follow-up study.

ABSTRACT:

Aim

Sacral neuromodulation (SNM) is considered the first-line surgical treatment in adults with refractory faecal incontinence (FI). However, its clinical efficacy has not been rigorously tested in a trial setting.

Method

Randomised, multicentre, double-blind crossover trial (two 16-week periods) of active stimulation versus sham, and open-label follow-up to 58 weeks.

Participants

adults aged 18-80 with refractory FI.

Interventions

Active: subsensory sacral nerve stimulation with an implanted pulse generator; Sham: identical implant but turned off.

Primary outcome

FI episodes per week (paper bowel diary) during final 4 weeks of crossover periods (allowing 12 weeks' washout). Randomised allocation (1:1) to arm 1 (SNM/sham) or arm 2 (sham/SNM).

Blinding

SUBMITTER: Vollebregt PF 

PROVIDER: S-EPMC12605715 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature