Efficacy and mechanism of sub-sensory sacral (optimised) neuromodulation in adults with faecal incontinence: study protocol for a randomised controlled trial.

Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE

Original Publication: [London] : BioMed Central, 2006-

Defecation* ; Lumbosacral Plexus*; Fecal Incontinence/*therapy ; Transcutaneous Electric Nerve Stimulation/*methods; Adolescent ; Adult ; Aged ; Cross-Over Studies ; Double-Blind Method ; Fecal Incontinence/diagnosis ; Fecal Incontinence/physiopathology ; Female ; Germany ; Humans ; Ireland ; Male ; Middle Aged ; Multicenter Studies as Topic ; Randomized Controlled Trials as Topic ; Recovery of Function ; Time Factors ; Treatment Outcome ; United Kingdom ; Young Adult

Background: Faecal incontinence (FI) is a substantial health problem with a prevalence of approximately 8% in community-dwelling populations. Sacral neuromodulation (SNM) is considered the first-line surgical treatment option in adults with FI in whom conservative therapies have failed. The clinical efficacy of SNM has never been rigorously determined in a trial setting and the underlying mechanism of action remains unclear.
Methods/design: The design encompasses a multicentre, randomised, double-blind crossover trial and cohort follow-up study. Ninety participants will be randomised to one of two groups (SNM/SHAM or SHAM/SNM) in an allocation ratio of 1:1. The main inclusion criteria will be adults aged 18-75 years meeting Rome III and ICI definitions of FI, who have failed non-surgical treatments to the UK standard, who have a minimum of eight FI episodes in a 4-week screening period, and who are clinically suitable for SNM. The primary objective is to estimate the clinical efficacy of sub-sensory SNM vs. SHAM at 32 weeks based on the primary outcome of frequency of FI episodes using a 4-week paper diary, using mixed Poisson regression analysis on the intention-to-treat principle. The study is powered (0.9) to detect a 30% reduction in frequency of FI episodes between sub-sensory SNM and SHAM stimulation over a 32-week crossover period. Secondary objectives include: measurement of established and new clinical outcomes after 1 year of therapy using new (2017 published) optimised therapy (with standardised SNM-lead placement); validation of new electronic outcome measures (events) and a device to record them, and identification of potential biological effects of SNM on underlying anorectal afferent neuronal pathophysiology (hypothesis: SNM leads to increased frequency of perceived transient anal sphincter relaxations; improved conscious sensation of defaecatory urge and cortical/subcortical changes in afferent responses to anorectal electrical stimulation (main techniques: high-resolution anorectal manometry and magnetoencephalography).
Discussion: This trial will determine clinical effect size for sub-sensory chronic electrical stimulation of the sacral innervation. It will provide experimental evidence of modifiable afferent neurophysiology that may aid future patient selection as well as a basic understanding of the pathophysiology of FI.
Trial Registration: International Standard Randomised Controlled Trial Number: ISRCTN98760715 . Registered on 15 September 2017.

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14/144/08 United Kingdom DH_ Department of Health; 14/144/08 Efficacy and Mechanism Evaluation Programme

Keywords: Anorectal manometry; Evoked potential; Faecal incontinence; Magneticoencepholograpy; Randomised controlled trial; Sacral nerve stimulation; Sacral neuromodulation

Date Created: 20180627 Date Completed: 20190314 Latest Revision: 20210120

20250114

PMC6019783

10.1186/s13063-018-2689-1

29941019