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

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

Continence technologies whitepaper: Informing new engineering science research

Advances in healthcare technology for continence have historically been limited compared to other areas of medicine, reflecting the complexities of the condition and social stigma which act as a barrier to participation. This whitepaper has been developed to inspire and direct the engineering science community towards research opportunities that exist for continence technologies that address unmet needs in diagnosis, treatment and long-term management. Our aim is to pinpoint key challenges and highlight related research opportunities for novel technological advances. To do so, we draw on experience and expertise from academics, clinicians, patients and patient groups linked to continence healthcare. This is presented in four areas of consideration: the clinical pathway, patient perspective, research challenges and effective innovation. In each we introduce seminal research, background information and demonstrative case-studies, before discussing their relevance to engineering science researchers who are interested in approaching this overlooked but vital area of healthcare

Prospective cohort study of high-volume transanal irrigation in patients with constipation and/or faecal incontinence

Aim: The aim of this work was to determine the clinical efficacy of high-volume transanal irrigation (TAI) in patients with constipation and/or faecal incontinence using validated symptom and quality of life questionnaires. Method: This was a prospective cohort study of 114 consecutive patients with constipation and/or faecal incontinence (Rome IV defined) who started TAI. A comprehensive questionnaire was completed at baseline and 4, 12, 26 and 52 weeks’ follow-up. The primary objective was significant symptom reduction [≥30%; Cleveland Clinic Constipation Score (CCCS) and St Marks Incontinence Score (SMIS)] in those who continued TAI at 52 weeks. Secondary objectives were (1) continuation rates of TAI, (2) effect on quality of life (QoL) and (3) identification of predictors for continuation. Results: A total of 59 (51.8%) patients with constipation, 26 (22.8%) with faecal incontinence and 29 (25.4%) with coexistent symptoms were included. At 52 weeks, 41 (36.0%) patients continued TAI, 63 (55.2%) stopped and 10 (8.8%) patients were lost to follow-up. In those who continued TAI at 52 weeks (n = 41), no reduction of constipation symptoms was observed. Median Patient Assessment of Constipation Quality of Life scores decreased on most domains, indicating QoL improvement. Reduction of faecal incontinence occurred in 5/9 (55.6%) patients with faecal incontinence and in 3/10 (30.0%) patients with coexistent symptoms. The median SMIS per-individual decreased in patients with coexistent symptoms (2; interquartile range 0–4; p = 0.023). Median Fecal Incontinence Quality of Life scores increased in most domains, indicating improved QoL. No clinical characteristics predicted continuation. Conclusion: One-third (n = 41) of patients continued TAI at 52 weeks. In those who continued TAI at 52 weeks, symptoms of faecal incontinence (SMIS) were reduced but not constipation (CCCS). QoL related to both constipation and faecal incontinence improved. No clinical characteristics predicted continuation

Surgery for constipation: systematic review and practice recommendations: Graded practice and future research recommendations.

AIM This manuscript forms the final of seven that address the surgical management of chronic constipation (CC) in adults. The content coalesces results from the five systematic reviews that precede it and of the European Consensus process to derive graded practice recommendations (GPR). METHODS Summary of review data, development of GPR and future research recommendations as outlined in detail in the 'introduction and methods' paper. RESULTS The overall quality of data in the five reviews was poor with 113/156(72.4%) of included studies providing only level IV evidence and only four included level I RCTs. Coalescence of data from the five procedural classes revealed that few firm conclusions could be drawn regarding procedural choice or patient selection: no single procedure dominated in addressing dynamic structural abnormalities of the anorectum and pelvic floor with each having similar overall efficacy. Of one hundred 'prototype' GPRs developed by the clinical guideline group, 85/100 were deemed 'appropriate' based on the independent scoring of a panel of 18 European experts and use of RAND-UCLA consensus methodology. The remaining 15 were all deemed uncertain. Future research recommendations included some potential RCTs but also a strong emphasis on delivery of large multinational high-quality prospective cohort studies. CONCLUSION While the evidence base for surgery in CC is poor, the widespread European consensus for GPRs is encouraging. Professional bodies have the opportunity to build on this work by supporting the efforts of their membership to help convert the documented recommendations into clinical guidelines