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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.

BackgroundFaecal 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.ObjectivesTo assess the effectiveness of PTNS compared with sham electrical stimulation in the treatment of patients with FI in whom initial conservative strategies have failed.DesignMulticentre, parallel-arm, double-blind randomised (1 : 1) controlled trial.SettingEighteen UK centres providing specialist nurse-led (or equivalent) treatment for pelvic floor disorders.ParticipantsParticipants aged > 18 years with FI who have failed conservative treatments and whose symptoms are sufficiently severe to merit further intervention.InterventionsPTNS 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 manufacturer’s 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 measuresOutcome 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).ResultsIn 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 Mark’s Continence Score or any quality-of-life measures. No serious adverse events related to treatment were reported.ConclusionsPTNS 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 registrationCurrent Controlled Trials ISRCTN88559475.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 77. See the NIHR Journals Library website for further project information.

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.

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.

BACKGROUND: 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.METHODS: 115 healthy subjects (96 female) underwent HRAM using a 10 channel, 12F solid-state catheter. Measurements were performed during rest, squeeze, cough, and simulated defecation (push). Data were displayed as color contour plots and analysed using a commercially available manometric system (Solar GI HRM v9.1, Medical Measurement Systems). Associations between age, gender and parity were subsequently explored.KEY RESULTS: HRAM color contour plots provided clear delineation of the high-pressure zone within the anal canal and showed recruitment during maneuvers that altered intra-anal pressures. Automated analysis produced quantitative data, which have been presented on the basis of gender and parity due to the effect of these covariates on some sphincter functions. In line with traditional manometry, some age and gender differences were seen. Males had a greater functional anal canal length and anal pressures during the cough maneuver. Parity in females was associated with reduced squeeze increments.CONCLUSIONS & INFERENCES: The study provides a large healthy volunteer dataset and parameters of traditional measures of anorectal function. A number of novel phenomena are appreciated, the significance of which will require further analysis and comparisons with patient populations.

Introduction Conventional anal manometry (CAM) is widely used to measure sphincter function in patients with fecal incontinence (FI). However, results correlate poorly with symptom severity and may have limited impact on patient management. This study evaluated the discriminant utility of novel measures of anal resting and squeeze function using highresolution anorectal manometry (HRAM) compared to conventional measures. Methods Ninety-five healthy female volunteers (HV) (age 42 ± 13 years) and 95 females with FI (age 55 ± 16 years) underwent HRAM (solid state, 10 channels, 8 mm spacing). CAM data were subsampled from HRAM data. In each participant the CAM squeeze increment (CAM-SI) and CAM resting pressure (CAM-R) were compared with new derived HRAM ‘profile' measures (squeeze [HRAM-SP] and rest [HRAM-RP]). Results were compared between groups and metrics of diagnostic accuracy derived. Results Median St Marks Incontinence score was 11 (IQR=7) for FI vs. 1 (IQR=1) for HV, p

Introduction Within the UK, there is anecdotal evidence of disparity in the training, practice, supervision, and perception of efficacy amongst practitioners of biofeedback therapy for chronic constipation. 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 online 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-tau, UKght. 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. Conclusion 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 consensus to standardise therapy. Disclosure of Interest None Declared.

Introduction Faecal incontinence and urgency are well-recognised sequelae of obstetric injury, however there is a paucity of literature describing the co-existence of symptoms of rectal evacuatory dysfunction (RED) and faecal incontinence (FI). This study aims to analyse and quantify these symptoms in patients referred for anorectal investigations following obstetric injury. Methods Consecutive patients undergoing specialist investigation at a tertiary referral unit following obstetric injury between 1st July 2010 and 31st July 2012 were identified. Symptoms at presentation were ascertained from the history. Patients routinely complete a Cleveland Clinic Constipation Score (CCCS) and Vaizey Incontinence score (VIS) prior to investigation. Symptoms volunteered by the patient were correlated with formal scoring systems to verify accuracy of symptom reporting and to study the co-existence of FI and RED. Results One hundred and sixty five women [median age 34 (range 19–55)] were included. Median parity was 2 [range 1–8]. Fourteen women (9.7%) had a 4th degree tear and 68 women (41%) a 3rd degree tear [106 (64%) occurring from the first vaginal delivery]. Three women requiring de-functioning stoma were excluded from further analysis. FI was volunteered in 87 women (54%), [59 urge FI (36%), 57 passive FI (35%) and 28 mixed FI (17%)]. Ninety women (56%) volunteered symptoms of RED. Co-existent symptoms of RED and FI were present in 58 women (36%). VIS and CCCS were available for 79 patients. Median VIS was 8 (IQR 4–13), and was significantly higher in those reporting FI symptoms [median score 11 (IQR 8–15)] than those not [median score 4 (IQR 0–8)] (p 5) and 39 patients (49%) had significant RED based on CCCS (score > 8). Thirty patients (38%) had scores compatible with significant co-existent FI and RED. Conclusion These results demonstrate symptoms of FI and RED often co-exist following obstetric injury regardless of method used to ascertain symptoms. A multi-modality treatment approach addressing overlapping pathophysiologies should be considered in these patients. Disclosure of Interest None Declared

Introduction Faecal incontinence can be associated with impaired anal sensitivity. Anal evoked potentials (EPs) have previously been used to quantify anal sensory function; however the traditional technique of stimulating at a percentage of pain threshold may result in poorly reproducible results with significant inter-individual variability. The aim of this study was to develop a reliable and reproducible method of recording anal EPs, and to define waveform characteristics in healthy volunteers. Methods Twenty eight healthy volunteers (21 F, median age 34 [range 21–74]) without bowel dysfunction were recruited for the study. Anal EPs were recorded in response to stimulation (using a bipolar electrode) 1cm from the anal verge. In contrast to previous studies, stimulation intensity was delivered at motor threshold (determined by visualisation of an anal ‘twitch’). Four sets of 50 stimuli (0.2 Hz frequency, 0.2 ms pulse duration) were given with 5-minute intervals between sets to reduce habituation. A repeat study was performed in 7 volunteers after a minimum interval of 2 weeks. Recordings were taken between channels Cz-A1 and Cz’-Fz (International 10–20 system) in accordance with previously published literature. Runs were averaged and latencies for EP responses were defined, analysed and compared. Results Motor threshold stimulation (median 20, range 10–36 mA) was well tolerated in all volunteers and resulted in reproducible polyphasic waveforms. The first negative peak (N1) was clearly identifiable on all traces. In the Cz’-Fz channel, the latency to N1 was 130 ± 20 ms (coefficient of variation [COV] = 15%). This was less variable than N1 in Cz-A1 (153 ± 34 ms; COV = 22%) and much less than published previously (COV of N1 = 39%; Remes-Troche et al. Neurogastroenterol Motil 2011). Analysis of repeat studies demonstrated that latencies in channel Cz’-Fz were the most reproducible (ICC of N1 latency = 0.95 [very strong agreement]). Conclusion Electrical stimulation at motor threshold and recording of evoked potentials from channel Cz’-Fz is a reliable and reproducible method for examination of anal sensory function. Latency to N1 is the most consistent waveform component and is highly reproducible. The technique of stimulation at ‘twitch’ threshold appears to reduce inter-subject variability and may allow application to further explore both the pathophysiology of anal dysfunction and the effect of treatments aimed at modulating anal neuronal function. Disclosure of Interest None Declared Reference Remes-Troche JM, Tantiphlachiva K, Attaluri A, et al . A bi-directional assessment of the human brain-anorectal axis. Neurogastroenterol Motil 2011; 23 : 240–248, e117–248

Background 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. Methods The review adhered to the PRISMA framework. A comprehensive search of the literature included PubMed, MEDLINE, Embase and Evidence-Based Medicine Reviews. Methodological quality assessment and data extraction were completed in a systematic fashion. Results For SNS, 321 citations were identified initially, of which 61 studies were eligible for inclusion. Of studies on other neuromodulation techniques, 11 were eligible for review: seven on percutaneous tibial nerve stimulation (PTNS) and four on transcutaneous tibial nerve stimulation (TTNS). On intention-to-treat, the median (range) success rates for SNS were 63 (33–66), 58 (52–81) and 54 (50–58) per cent in the short, medium and long terms respectively. The success rate for PTNS was 59 per cent at the longest reported follow-up of 12 months. SNS, PTNS and TTNS techniques also resulted in improvements in Cleveland Clinic Incontinence Score and quality-of-life measures. Despite significant use of neuromodulation in treatment of FI, there is still no consensus on outcome reporting in terms of measures used, aetiologies assessed, length of follow-up or assessment standards. Conclusion Emerging data for SNS suggest maintenance of its initial therapeutic effect into the long term. The clinical effectiveness of PTNS is comparable to that of SNS at 12 months, although there is no evidence to support its continued effectiveness after this period. PTNS may be a useful treatment before SNS. The clinical effectiveness of TTNS is still uncertain owing to the paucity of available evidence. A consensus to standardize the use of outcome measures is recommended in order that further reports can be compared meaningfully.

Background 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. Methods A systematic review was performed adhering to the PRISMA framework. A comprehensive literature search was conducted, with systematic methodological quality assessment and data extraction. Summary measures for individual outcome variables are reported. Results Twelve articles met eligibility criteria; six related to PTNS, five to TTNS, and one to both procedures. These included ten case series and two randomized clinical trials (RCTs). Case series were evaluated using the National Institute for Health and Care Excellence quality assessment for case series, scoring 3–6 of 8. RCTs were evaluated using the Jadad score, scoring 4 of a possible 5 marks, and the Cochrane Collaboration bias assessment tool. From one RCT and case series reports, the success rate of PTNS, based on the proportion of patients who achieved a reduction in weekly FI episodes of at least 50 per cent, was 63–82 per cent, and that of TTNS was 0–45 per cent. In an RCT of TTNSversus sham, no patient had a reduction in weekly FI episodes of 50 per cent or more, whereas in an RCT of PTNSversus TTNSversus sham, 82 per cent of patients undergoing PTNS, 45 per cent of those having TTNS, and 13 per cent of patients in the sham group had treatment success. Conclusion PTNS and TTNS result in significant improvements in some outcome measures; however, TTNS was not superior to sham stimulation in a large, adequately powered, RCT. As no adequate RCT of PTNSversus sham has been conducted, conclusions cannot be drawn regarding this treatment.