Emma J Horrocks

Systematic review of the clinical effectiveness of neuromodulation in the treatment of faecal incontinence

Over the past 18 years neuromodulation therapies have gained support as treatments for faecal incontinence (FI); sacral nerve stimulation (SNS) is the most established of these. A systematic review was performed of current evidence regarding the clinical effectiveness of neuromodulation treatments for FI.

Traditional measures of normal anal sphincter function using high-resolution anorectal manometry (HRAM) in 115 healthy volunteers

High‐resolution anorectal manometry (HRAM) is a relatively new method for collection and interpretation of data relevant to sphincteric function, and for the first time allows a global appreciation of the anorectum as a functional unit. Historically, traditional anal manometry has been plagued by lack of standardization and healthy volunteer data of variable quality. The aims of this study were: (i) to obtain normative data sets for traditional measures of anorectal function using HRAM in healthy subjects and; (ii) to qualitatively describe novel physiological phenomena, which may be of future relevance when this method is applied to patients.

Systematic review of tibial nerve stimulation to treat faecal incontinence

Two forms of tibial nerve stimulation are used to treat faecal incontinence (FI): percutaneous (PTNS) and transcutaneous (TTNS) tibial nerve stimulation. This article critically appraises the literature on both procedures.

Diagnostic accuracy study of anorectal manometry for diagnosis of dyssynergic defecation

Objective The diagnostic accuracy of anorectal manometry (AM), which is necessary to diagnose functional defecatory disorders (FDD), is unknown. Using blinded analysis and standardised reporting of diagnostic accuracy, we evaluated whether AM could discriminate between asymptomatic controls and patients with functional constipation (FC). Design Derived line plots of anorectal pressure profiles during simulated defecation were independently analysed in random order by three expert observers blinded to health status in 85 women with FC and 85 age-matched asymptomatic healthy volunteers (HV). Using accepted criteria, these pressure profiles were characterised as normal (ie, increased rectal pressure coordinated with anal relaxation) or types I–IV dyssynergia. Interobserver agreement and diagnostic accuracy were determined. Results Blinded consensus-based assessment disclosed a normal pattern in 16/170 (9%) of all participants and only 11/85 (13%) HV. The combined frequency of dyssynergic patterns (I–IV) was very similar in FC (80/85 (94%)) and HV (74/85 (87%)). Type I dyssynergia (‘paradoxical’ contraction) was less prevalent in FC (17/85 (20%) than in HV (31/85 (36.5%), p=0.03). After statistical correction, only type IV dyssynergia was moderately useful for discriminating between FC (39/85 (46%)) and HV (17/85 (20%)) (p=0.001, positive predictive value=70.0%, positive likelihood ratio=2.3). Interobserver agreement was substantial or moderate for identifying a normal pattern, dyssynergia types I and IV, and FDD, and fair for types II and III. Conclusions While the interpretation of AM patterns is reproducible, nearly 90% of HV have a pattern that is currently regarded as ‘abnormal’ by AM. Hence, AM is of limited utility for distinguishing between FC and HV.

Double-blind randomised controlled trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in the treatment of faecal incontinence: CONtrol of Faecal Incontinence using Distal NeuromodulaTion (the CONFIDeNT trial)

BACKGROUND Faecal incontinence (FI) is a common condition which is often under-reported. It is distressing for those suffering from it, impacting heavily on their quality of life. When conservative strategies fail, treatment options are limited. Percutaneous tibial nerve stimulation (PTNS) is a minimally invasive outpatient treatment, shown in preliminary case series to have significant effectiveness; however, no randomised controlled trial has been conducted. OBJECTIVES To assess the effectiveness of PTNS compared with sham electrical stimulation in the treatment of patients with FI in whom initial conservative strategies have failed. DESIGN Multicentre, parallel-arm, double-blind randomised (1 : 1) controlled trial. SETTING Eighteen UK centres providing specialist nurse-led (or equivalent) treatment for pelvic floor disorders. PARTICIPANTS Participants aged > 18 years with FI who have failed conservative treatments and whose symptoms are sufficiently severe to merit further intervention. INTERVENTIONS PTNS was delivered via the Urgent(®) PC device (Uroplasty Limited, Manchester, UK), a hand-held pulse generator unit, with single-use leads and fine-needle electrodes. The needle was inserted near the tibial nerve on the right leg adhering to the manufacturers protocol (and specialist training). Treatment was for 30 minutes weekly for a duration of 12 treatments. Validated sham stimulation involved insertion of the Urgent PC needle subcutaneously at the same site with electrical stimulation delivered to the distal foot using transcutaneous electrical nerve stimulation. MAIN OUTCOME MEASURES Outcome measures were assessed at baseline and 2 weeks following treatment. Clinical outcomes were derived from bowel diaries and validated, investigator-administered questionnaires. The primary outcome classified patients as responders or non-responders, with a responder defined as someone having achieved ≥ 50% reduction in weekly faecal incontinence episodes (FIEs). RESULTS In total, 227 patients were randomised from 373 screened: 115 received PTNS and 112 received sham stimulation. There were 12 trial withdrawals: seven from the PTNS arm and five from the sham arm. Missing data were multiply imputed. For the primary outcome, the proportion of patients achieving a ≥ 50% reduction in weekly FIEs was similar in both arms: 39 in the PTNS arm (38%) compared with 32 in the sham arm (31%) [odds ratio 1.28, 95% confidence interval (CI) 0.72 to 2.28; p = 0.396]. For the secondary outcomes, significantly greater decreases in weekly FIEs were observed in the PTNS arm than in the sham arm (beta -2.3, 95% CI -4.2 to -0.3; p = 0.02), comprising a reduction in urge FIEs (p = 0.02) rather than passive FIEs (p = 0.23). No significant differences were found in the St Marks Continence Score or any quality-of-life measures. No serious adverse events related to treatment were reported. CONCLUSIONS PTNS did not show significant clinical benefit over sham electrical stimulation in the treatment of FI based on number of patients who received at least a 50% reduction in weekly FIE. It would be difficult to recommend this therapy for the patient population studied. Further research will concentrate on particular subgroups of patients, for example those with pure urge FI. TRIAL REGISTRATION Current Controlled Trials ISRCTN88559475. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 77. See the NIHR Journals Library website for further project information.

Outcome of sacral nerve stimulation for fecal incontinence in patients refractory to percutaneous tibial nerve stimulation.

BACKGROUND: Percutaneous tibial nerve stimulation and sacral nerve stimulation are both second-line treatments for fecal incontinence, but the comparative efficacy of the 2 therapies is unknown. In our institution, patients with refractory fecal incontinence are generally treated with percutaneous tibial nerve stimulation before being considered for sacral nerve stimulation. OBJECTIVE: The aim of this study was to assess the outcome associated with this treatment algorithm in order to guide future management strategies. DESIGN: All patients with fecal incontinence treated over a 3-year period with tibial nerve stimulation before receiving sacral nerve stimulation were identified from a prospectively recorded database. Demographics and pretreatment anorectal physiological data were available for all patients. SETTINGS: This study was conducted at an academic colorectal unit in a tertiary center. PATIENTS: Twenty patients (17 female:3 male, median age 55 (33–79) years) were identified to be refractory to percutaneous tibial nerve stimulation. MAIN OUTCOME MEASURES: Clinical outcome data were collected prospectively before and after treatment, including 1) Cleveland Clinic Florida-Fecal Incontinence scores and 2) number of incontinence episodes per week. RESULTS: The mean (±SD) pretreatment incontinence score (11.7 ± 3.5) did not differ from the mean incontinence score after 12 sessions of tibial nerve stimulation (10.9 ± 3.6, p = 0.42). All patients were subsequently counseled for sacral nerve stimulation, and 68.4% of them reported a significant therapeutic benefit with an improved incontinence score (7.7 ± 4.1, p = 0.014). LIMITATIONS: This was a nonrandomized study with a relatively small number of patients CONCLUSION: Sacral nerve stimulation appears to be an effective treatment for patients who do not gain an adequate therapeutic benefit from percutaneous tibial nerve stimulation and, thus, should be routinely considered for this patient cohort.

Factors Associated With Efficacy of Percutaneous Tibial Nerve Stimulation for Fecal Incontinence, Based on Post-Hoc Analysis of Data From a Randomized Trial

BACKGROUND & AIMS: A recent randomized, multi‐center, phase 3 trial, performed in the United Kingdom (Control of Fecal Incontinence using Distal Neuromodulation Trial), demonstrated no significant clinical benefit of percutaneous tibial nerve stimulation (PTNS) compared to sham stimulation in patients with fecal incontinence (FI). However, this study did not analyze predictors of response. We used data from this trial to identify factors that predict the efficacy of PTNS in adults with FI. METHODS: The study population comprised 205 patients from the CONtrol of Fecal Incontinence using Distal NeuromodulaTion Trial. The primary outcome was a binary indicator of success (≥50% reduction in weekly FI episodes after 12 weeks of treatment) or failure, as per the original trial characteristics including baseline FI symptom type, defecatory urgency, and co‐existent symptoms of baseline liquid stool consistency and obstructive defecation (OD) were defined a priori. Univariable and multivariable analyses were performed to explore these factors as predictors of response to PTNS and sham. RESULTS: In both univariable and multivariable analysis, the presence of OD symptoms negatively predicted outcome in patients who received PTNS (OR, 0.38; 95% CI, 0.16–0.91; P = .029), and positively predicted sham response (OR, 3.45; 95% CI, 1.31–9.21; P = .012). No other tested variable affected outcome. Re‐analysis of the primary outcome excluding patients with OD symptoms (n = 112) resulted in a significant clinical effect of PTNS compared to sham (48.9% vs 18.2% response, P = .002; multivariable OR, 4.71; 95% CI, 1.71–12.93; P = .003). CONCLUSIONS: Concomitant OD symptoms negatively affected the clinical outcome of PTNS vs sham in a major randomized controlled trial. Future appropriately designed studies could further explore this observation with potential for future stratified patient selection.

Surgery for constipation: systematic review and practice recommendations: Results IV: Recto-vaginal reinforcement procedures.

To assess the outcomes of recto‐vaginal reinforcement procedures in adults with chronic constipation.

Surgery for constipation: systematic review and clinical guidance: Paper 1: Introduction & Methods.

This manuscript provides the introduction and detailed methodology used in subsequent reviews to assess the outcomes of surgical interventions with the primary intent of treating chronic constipation in adults and to develop recommendations for practice.

A National Biofeedback Practitioners Service Evaluation: Focus on Chronic Idiopathic Constipation

Introduction Within the UK, there is anecdotal evidence of disparity in the training, practice, supervision and perception of efficacy among practitioners of biofeedback therapy for chronic constipation. Aims To establish the current knowledge, practice and opinions of UK practitioners. Methods Between October 2012 and October 2013, a prospective service evaluation was distributed to biofeedback practitioners in the UK through academic conferences or by invitation to complete an on-line assessment form. Results 76 practitioners responded, consisting of nurses (47%), physiotherapists (35%), physiologists (12%) and others (7%). Only 45% described ‘biofeedback’ consistent with an accepted definition. 86% use equipment to provide sensory feedback. Methods of biofeedback varied: balloon catheter (54%), brace pump technique (78%), urge resistance (83%), irrigation (16%) and relaxation (12%). Only 65% of practitioners had attended formal training courses, and 52% considered themselves to be self-taught. 36% receive formal supervision and only 38% of those by a senior. Regular audit of outcomes is undertaken by 67%. UK-wide perception of treatment response for chronic constipation is markedly variable (mean response=57% (IQR 50–75%, SD 23%)); there were no differences in perception of treatment response between nurses or physiotherapists. Practitioners’ free responses demonstrated strong positive themes of a holistic approach and an overall perception of effectiveness. Negative themes included service restrictions. Conclusions There is marked variation in practice, training and supervision of biofeedback therapists throughout the UK. Perceptions of efficacy vary greatly. Development of training and supervision standards is a priority as well as a consensus to standardise therapy.