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Neuropathy may cause fecal incontinence and mixed fecal incontinence/constipation, but its prevalence is unclear, partly due to the lack of comprehensive testing of spino-anorectal innervation.This study aimed to develop and determine the clinical usefulness of a novel test, translumbosacral anorectal magnetic stimulation for fecal incontinence.This observational cohort study was conducted from 2012 to 2018.This study was performed at a tertiary referral center.Patients with fecal incontinence, patients with mixed fecal incontinence/constipation, and healthy controls were included.A translumbosacral anorectal magnetic stimulation test was performed by using an anorectal probe with 4 ring electrodes and magnetic coil, and by stimulating bilateral lumbar and sacral plexuses, uses and recording 8 motor-evoked potentials at anal and rectal sites.The prevalence of lumbar and/or sacral neuropathy was examined. Secondary outcomes were correlation of neuropathy with anorectal sensorimotor function(s) and morphological changes.We evaluated 220 patients: 144 with fecal incontinence, 76 with mixed fecal incontinence/constipation, and 31 healthy controls. All 8 lumbar and sacral motor-evoked potential latencies were significantly prolonged (p0.01) in fecal incontinence and mixed fecal incontinence/constipation groups compared with controls. Neuropathy was patchy and involved 4.0 (3.0) (median (interquartile range)) sites. Lumbar neuropathy was seen in 29% to 65% of the patients in the fecal incontinence group and 22% to 61% of the patients in the mixed fecal incontinence/constipation group, and sacral neuropathy was seen in 24% to 64% and 29% to 61% of these patients. Anal neuropathy was significantly more (p0.001) prevalent than rectal neuropathy in both groups. There was no correlation between motor-evoked potential latencies and anal sphincter pressures, rectal sensation, or anal sphincter defects.No comparative analysis with electromyography was performed.Lumbar or sacral plexus neuropathy was detected in 40% to 75% of patients with fecal incontinence with a 2-fold greater prevalence at the anal region than the rectum. Lumbosacral neuropathy appears to be an independent mechanism in the pathogenesis of fecal incontinence, unassociated with other sensorimotor dysfunctions. Translumbosacral anorectal magnetic stimulation has a high yield and is a safe and clinically useful neurophysiological test. See Video Abstract at http://links.lww.com/DCR/B728.ANTECEDENTES:La neuropatía puede causar incontinencia fecal y una combinación de incontinencia fe-cal/estreñimiento, pero su prevalencia no está clara, en parte debido a la falta de pruebas comple-tas de inervación espino-anorrectal.OBJETIVO:Desarrollar y determinar la utilidad clínica de una nueva prueba, estimulación magnética trans-lumbosacral anorrectal para la incontinencia fecal.DISEÑO:Estudio de cohorte observacional del 2012 al 2018.ENTORNO CLINICO:Centro de referencia terciario.PACIENTES:Pacientes con incontinencia fecal, combinación de incontinencia fecal/estreñimiento y controles sanos.INTERVENCIONES:Se realizó una prueba de estimulación magnética translumbosacral anorrectal utilizando una sonda anorrectal con 4 electrodos anulares y bobina magnética, y estimulando los plexos lumbares y sacros bilaterales y registrando ocho potenciales evocados motores las regiones anal y rectal.PRINCIPALES MEDIDAS DE RESULTADO:Se examinó la prevalencia de neuropatía lumbar y/o sacra. Los resultados secundarios fueron la correlación de la neuropatía con las funciones sensitivomotoras anorrectales y cambios morfológi-cos.RESULTADOS:Evaluamos 220 pacientes, 144 con incontinencia fecal, 76 con combinación de incontinencia fe-cal/estreñimiento y 31 sujetos sanos. Las ocho latencias de los potenciales evocadas motoras lum-bares y sacras se prolongaron significativamente (p0,01) en la incontinencia fecal y el grupo mixto en comparación con los controles. La neuropatía fue irregular y afectaba 4,0 (3,0) (mediana (rango intercuartílico) sitios. Se observó neuropatía lumbar en 29-65% en la incontinencia fecal y 22-61% en el grupo mixto, y neuropatía sacra en 24-64% y 29-61 % de pacientes respectivamen-te. La neuropatía anal fue significativamente más prevalente (p0,001) que la rectal en ambos grupos. No hubo correlación entre las latencias de los potenciales evocadas motoras y las presio-nes del esfínter anal, la sensación rectal o los defectos del esfínter anal.LIMITACIONES:Sin análisis comparativo con electromiografía.CONCLUSIÓNES:Se detectó neuropatía del plexo lumbar o sacro en el 40-75% de los pacientes con incontinencia fecal con una prevalencia dos veces mayor en la región anal que en el recto. La neuropatía lumbo-sacra parece ser un mecanismo independiente en la patogenia de la incontinencia fecal, no asocia-do con otras disfunciones sensitivomotoras. La estimulación magnética translumbosacral anorrec-tal tiene un alto rendimiento, es una prueba neurofisiológica segura y clínicamente útil. Consulte Video Resumen en http://links.lww.com/DCR/B728.

Summary Background Chronic constipation is a common, heterogeneous disorder with multiple symptoms and pathophysiological mechanisms. Patients are often referred to a gastroenterology provider after laxatives fail. However, there is limited knowledge of the spectrum and management of constipation disorders. Aim To discuss the latest understanding of the spectrum of constipation disorders, tools for identifying a pathophysiologic‐based diagnosis in the specialist setting, treatment options and the patient's perspective of constipation. Methods Literature searches were conducted using PubMed for constipation diagnostic criteria, diagnostic tools and approved treatments. The authors provided insight from their own practices. Results Clinical assessment, stool diaries and Rome IV diagnostic criteria can facilitate diagnosis, evaluate severity and distinguish between IBS with constipation, chronic idiopathic constipation and dyssynergic defecation. Novel smartphone applications can help track constipation symptoms. Rectal examinations, anorectal manometry and balloon expulsion, assessments of neuromuscular function with colonic transit time and colonic manometry can provide mechanistic understanding of underlying pathophysiology. Treatments include lifestyle and diet changes, biofeedback therapy and pharmacological agents. Several classes of laxatives, as well as prokinetic and prosecretory agents, are available; here we describe their mechanisms of action, efficacy and side effects. Conclusions Constipation includes multiple overlapping subtypes identifiable using detailed history, current diagnostic tools and smartphone applications. Recognition of individual subtype(s) could pave the way for optimal, evidence‐based treatments by a gastroenterology provider., Gastroenterology providers should be familiar with the constipation subtypes and their underlying pathophysiology, as well as key signalling pathways that may contribute to constipation. Familiarisation with the varied mechanisms of action, expected efficacy and side effects of available therapies helps to select the appropriate treatment and meet patient expectations.

To provide an up-to-date review on the clinical assessment of two important gastrointestinal problems with overlapping symptomatology but diverse cause and testing methods. Small intestinal bacterial overgrowth (SIBO) is characterized by the presence of excess bacteria in the small intestine associated with bloating, distention, gas, and diarrhea. Lactose intolerance is caused by lactase enzyme deficiency in the small bowel mucosa leading to lactose malabsorption and symptoms of bloating, gas, and diarrhea.SIBO is assessed by hydrogen/methane breath test using glucose as a substrate and/or small bowel aspirate and culture but these tests have shortcomings. Consequently, several new diagnostic techniques, including novel capsule technologies and other approaches are being evaluated. Lactose intolerance can be assessed by hydrogen/methane breath test using lactose as a substrate, or small bowel mucosal lactase assay, genetic testing and lactose tolerance test, although the efficacy and practicality of these diagnostic modalities are not equal.In clinical practice, gas, bloating, distention, pain, and diarrhea are common gastrointestinal symptoms that often remain unexplained when routine gastrointestinal endoscopy, imaging, and stool tests are negative. These patients should be evaluated for SIBO and/or food intolerances including lactose intolerance.

Introduction Constipation is commonly treated with over-the-counter (OTC) products whose efficacy and safety remain unclear. We performed a systematic review of OTC therapies for chronic constipation and provide evidence-based recommendations. Methods We searched PubMed and Embase for randomized controlled trials of ≥4-week duration that evaluated OTC preparations between 2004 and 2020. Studies were scored using the US Preventive Services Task Force criteria (0-5 scale) including randomization, blinding, and withdrawals. The strengths of evidence were adjudicated within each therapeutic category, and recommendations were graded (A, B, C, D, and I) based on the level of evidence (level I, good; II, fair; or III, poor). Results Of 1,297 studies identified, 41 met the inclusion criteria. There was good evidence (grade A recommendation) for the use of the osmotic laxative polyethylene glycol (PEG) and the stimulant senna; moderate evidence (grade B) for psyllium, SupraFiber, magnesium salts, stimulants (bisacodyl and sodium picosulfate), fruit-based laxatives (kiwi, mango, prunes, and ficus), and yogurt with galacto-oligosaccharide/prunes/linseed oil; and insufficient evidence (grade I) for polydextrose, inulin, and fructo-oligosaccharide. Diarrhea, nausea, bloating, and abdominal pain were common adverse events, but no serious adverse events were reported. Discussion The spectrum of OTC products has increased and quality of evidence has improved, but methodological issues including variability in study design, primary outcome measures, trial duration, and small sample sizes remain. We found good evidence to recommend polyethylene glycol or senna as first-line laxatives and moderate evidence supporting fiber supplements, fruits, stimulant laxatives, and magnesium-based products. For others, further validation with more rigorously designed studies is warranted.

Constipation, irritable bowel syndrome, fecal incontinence, abdominal pain, and anorectal pain are problems that affect 40% of the population. They commonly present with overlapping symptoms indicating that their pathophysiology affects multiple segments of the gut as well as brain and gut interactions. Clinically, although some conditions are readily recognized, dyssynergic defecation, fecal incontinence, and anorectal pain are often missed or misdiagnosed. Consequently, the assessment of lower gastrointestinal symptoms in patients with suspected colonic or anorectal motility disorder(s) remains challenging for most clinicians. A detailed history, use of the Bristol stool form scale, prospective stool diaries, ideally through a phone App, digital rectal examination, and judicious use of complementary diagnostic tests are essential. Additionally, it is important to evaluate the impact of these problems on quality of life and psychosocial issues, because they are intricately linked with these disorders. The Rome IV diagnostic questionnaire for functional gastrointestinal disorders can provide additional information often missed during history taking. Here, we discuss a systematic approach for the clinical evaluation of patients with suspected lower gastrointestinal problems, grouped under 4 common diagnostic categories. We describe how to take a detailed history, perform meticulous digital rectal examination, and use validated tools to supplement clinical evaluation, including assessments of quality of life and scoring systems for disease severity and digital Apps. These tools could facilitate a comprehensive plan for clinical management including diagnostic tests, and translate the patients’ complaints into definable, diagnostic categories. (J Neurogastroenterol Motil 2020;26:423-436)

Goals To assess short-term and long-term effects of lubiprostone, a type-2 chloride channel activator, on electrolyte homeostasis. Background Conventional laxatives are associated with electrolyte imbalances. Lubiprostone is a type-2 chloride channel activator approved for treating chronic idiopathic constipation (CIC), opioid-induced constipation (OIC), and constipation-predominant irritable bowel syndrome in women. It induces intestinal fluid secretion, possibly affecting water and electrolyte homeostasis. We investigated short-term and long-term effects of lubiprostone on electrolyte, blood urea nitrogen (BUN), and creatinine levels using pooled data from CIC and OIC patients. Study Data were pooled from 10 CIC and OIC studies-6 double-blind, randomized, placebo-controlled studies and 4 open-label, long-term studies. Total duration of lubiprostone exposure was from 3 weeks (short-term: CIC, 3 to 4 wk; OIC, placebo-controlled, 12 wk) to 48 weeks (long-term: CIC, 24 to 48 wk; OIC, 48 wk). Sodium, chloride, potassium, magnesium, BUN, and creatinine levels were examined at baseline and final assessment. Results Overall, 3209 patients were assessed. In the double-blind, placebo-controlled studies, there were no clinically meaningful differences in levels of electrolytes, BUN, and creatinine between lubiprostone and placebo groups, and in changes from baseline levels with long-term use of lubiprostone. Analyses of shifts in laboratory values (low/normal/high) at baseline and final assessment showed minimal effects on electrolytes, BUN, and creatinine. Conclusions Lubiprostone did not cause clinically meaningful electrolyte imbalances or affect markers of renal function in either the short-term or long-term treatment of CIC or OIC.

Summary Background Linaclotide, a guanylate cyclase C agonist relieves irritable bowel syndrome with predominant constipation (IBS‐C) symptoms, but how it improves pain in humans is unknown. Aims To investigate the effects of linaclotide and placebo on the afferent and efferent gut‐brain‐gut signalling in IBS‐C patients, in a randomised clinical trial. Methods Patients with IBS‐C (Rome III) and rectal hypersensitivity were randomised (2:1) to receive linaclotide (290 µg) or placebo for 10 weeks and undergo bi‐directional gut and brain axis assessment using anorectal electrical stimulations and transcranial/transspinal‐anorectal magnetic stimulations. Rectal sensations were examined by balloon distention. Assessments included abdominal pain, bowel symptoms and quality of life (QOL) scores. Primary outcomes were latencies of recto‐cortical and cortico‐rectal evoked potentials. Results Thirty‐nine patients participated; 26 received linaclotide and 13 received placebo. Rectal cortical evoked potentials latencies (milliseconds) were significantly prolonged with linaclotide compared to baseline (P1:Δ 19 ± 6, P

Constipated patients are frequently referred to gastroenterologists for symptoms refractory to lifestyle modifications and laxatives. Dyssynergic defecation, the dyscoordination of rectoanal, abdominal, and pelvic floor muscles to facilitate defecation, is a major cause of refractory primary constipation. Understanding of the diagnosis, evaluation, and management of dyssynergic defecation and other evacuation disorders will allow providers to effectively manage these patients. This review focuses on the definition, pathophysiology, evaluation, and treatment of dyssynergic defecation and other evacuation disorders. Emerging treatments for these disorders include home biofeedback therapy for dyssynergic defecation and translumbosacral neuromodulation therapy for levator ani syndrome.

The endoscopy suite is the central hub of activity where most gastroenterologists spend a majority of their time in clinical practice. With the evolution of more complex diagnostic and therapeutic procedures, an ergonomically designed and dedicated gastrointestinal endoscopic unit is not only desirable but a necessity. Such a unit will ensure optimal workflow efficiency and throughput, as well as both patient and physician safety. It is important to plan meticulously upfront by seeking input from all stakeholders including engineers, physicians, nurses, technicians and architects. This will ensure a highly desirable work environment including procedural areas and the scope cleaning/sterilization section while optimizing patient and instrument flow. The procedure room should be ergonomically designed to allow for adjustability and optimize utilization of space for endoscopists, technicians, nurses, anesthesiologists, and trainees as well as the equipment required to perform the endoscopic procedures. This article provides practical tips on how to plan and develop an endoscopy suite, taking into consideration ergonomic and regulatory aspects, and is based on real life experience with designing a modern gastroenterology procedural suite.

BACKGROUND Rectal hyposensitivity (RH) is a well-known pathophysiological dysfunction in chronic constipation. Whether biofeedback training improves RH and restores bowel function is unknown. AIM To investigate the efficacy of barostat-assisted sensory training (BAST) with syringe-assisted sensory training (SAST) in patients with RH in a randomized controlled trial. METHODS Patients with RH and chronic constipation (Rome III) were randomized to receive 6 biweekly sessions of BAST or SAST. Verbal/visual feedback was provided during repeated rectal distensions to improve defecation desire/urge and first sensations with either 10-cm balloon connected to barostat (BAST) or 4-cm balloon connected to syringe and manometry probe (SAST). Sensory thresholds, bowel symptoms, and therapist and patient's rating of treatments were compared. The primary outcome (responders) was the improvement in ≥2 sensory thresholds. RESULTS Sixty-six patients were enrolled: 32 received BAST, 34 received SAST, and 56 completed study. There were significantly more responders in BAST group than SAST (78% vs. 53%, p = 0.0320). Rectal sensation normalized in 81% with BAST compared to 56% with SAST (p = 0.0270). When compared to baseline, desire and urge to defecate thresholds and bowel satisfaction improved with BAST (p = 0.0013; p = 0.0002; p = 0.0001) and SAST (p = 0.0012; p = 0.0001; p

OBJECTIVES: Translumbosacral neuromodulation therapy (TNT) improves symptoms of fecal incontinence (FI), but its mechanism of action is unknown. We tested the hypothesis that TNT at one or more frequency will significantly improve underlying pathophysiology of FI through modulation of ascending and/or descending signaling pathways in the gut and brain axis and anorectal sensorimotor function. MATERIALS AND METHODS: We assessed afferent anorectal-cortical evoked potentials (CEP) following electrical stimulation of anorectum, efferent cortico-anorectal and lumbo-anorectal and sacro-anorectal motor evoked potentials (MEP) after transcranial and lumbosacral magnetic stimulations, and anorectal manometry before and after six weekly TNT sessions in FI subjects, randomized to 1 Hz, 5 Hz or 15 Hz repetitive magnetic stimulations. Neurophysiology, anorectal sensorimotor function and symptoms were compared to examine mechanistic effects. Co-primary measures were ano-cortical CEPs, cortico-anal MEPs and lumbosacral-anal MEPs. Baseline and post-treatment data were compared with Wilcoxon signed-rank test and changes between the three frequencies with one-way ANOVA. RESULTS: Thirty-three FI patients participated. After TNT, the afferent anal CEP latencies significantly decreased in the 1 Hz group compared to baseline (p=0.0029) and 5 Hz or 15 Hz groups (p=0.032). Cortico-anal MEPs were unchanged in all three groups. Bilateral lumbo-anal and sacro-anal MEP latencies significantly decreased with 1 Hz, lumbo-anal with 15 Hz and sacro-anal with 5 Hz compared to baseline, but without group differences. The 1 Hz group showed significant increase in anal squeeze sphincter pressure (p

BACKGROUND Biofeedback therapy is useful for treatment of fecal incontinence (FI), but is not widely available and labor intensive. We investigated if home biofeedback therapy (HBT) is non-inferior to office biofeedback therapy (OBT). METHODS Patients with FI (≥1 episode/week) were randomized to HBT or OBT for 6 weeks. HBT was performed daily using novel device that provided resistance training and electrical stimulation with voice-guided instructions. OBT consisted of six weekly sessions. Both methods involved anal strength, endurance, and coordination training. Primary outcome was change in weekly FI episodes. FI improvement was assessed with stool diaries, validated instruments (FISI, FISS, and ICIQ-B), and anorectal manometry using intention-to-treat analysis. KEY RESULTS Thirty (F/M = 26/4) FI patients (20 in HBT, 10 in OBT) participated. Weekly FI episodes decreased significantly after HBT (Δ ± 95% confidence interval: 4.7 ± 1.8, compared with baseline, p = 0.003) and OBT (3.7 ± 1.6, p = 0.0003) and HBT was non-inferior to OBT (p = 0.2). The FISI and FISS scores improved significantly in HBT group (p

The goal of this monograph will focus on emerging treatment updates, reviewing current treatment guidelines, and advances in the management of irritable bowel syndrome (IBS).

BACKGROUND. The equipment and methods for performing anorectal manometry and biofeedback therapy are different and not standardized. Normal values are influenced by age and sex. Our aims were to generate reference values, examine effects of gender and age, and compare anorectal pressures measured with diagnostic and biofeedback catheters and a portable manometry system. METHODS. In this multicenter study, anorectal pressures at rest, during squeeze, and evacuation were measured with diagnostic and biofeedback catheters using Mcompass™ portable device in healthy subjects. Balloon expulsion time and rectal sensation were evaluated. The effects of age and gender were assessed. RESULTS. The final dataset comprised 108 (74 women) of 124 participants with normal rectal balloon expulsion time (less than 60 seconds). During squeeze, anal resting pressure increased by approximately twofold in women and threefold in men. During evacuation, anal pressure exceeded rectal pressure in 87 participants (diagnostic catheter). The specific rectoanal pressures (eg, resting pressure) were significantly correlated and not different between diagnostic and biofeedback catheters. With the diagnostic catheter, the anal squeeze pressure and rectal pressure during evacuation were greater in men than women (P ≤ 0.02). Among women, women aged 50 years and older had lower anal resting pressure; rectal pressure and the rectoanal gradient during evacuation were greater in older than younger women (P ≤ 0.01). CONCLUSIONS. Anal and rectal pressures measured with diagnostic and biofeedback manometry catheters were correlated and not significantly different. Pressures were influenced by age and sex, providing reference values in men and women.

The American Neurogastroenterology and Motility Society Task Force recommends that gastrointestinal motility procedures should be performed in motility laboratories adhering to the strict recommendations and personal protective equipment (PPE) measures to protect patients, ancillary staff, and motility allied health professionals. When available and within constraints of institutional guidelines, it is preferable for patients scheduled for motility procedures to complete a coronavirus disease 2019 (COVID-19) test within 48 hours before their procedure, similar to the recommendations before endoscopy made by gastroenterology societies. COVID-19 test results must be documented before performing procedures. If procedures are to be performed without a COVID-19 test, full PPE use is recommended, along with all social distancing and infection control measures. Because patients with suspected motility disorders may require multiple procedures, sequential scheduling of procedures should be considered to minimize need for repeat COVID-19 testing. The strategies for and timing of procedure(s) should be adapted, taking into consideration local institutional standards, with the provision for screening without testing in low prevalence areas. If tested positive for COVID-19, subsequent negative testing may be required before scheduling a motility procedure (timing is variable). Specific recommendations for each motility procedure including triaging, indications, PPE use, and alternatives to motility procedures are detailed in the document. These recommendations may evolve as understanding of virus transmission and prevalence of COVID-19 infection in the community changes over the upcoming months.

OBJECTIVES Motility and functional disorders are common in children and often debilitating, yet these disorders remain challenging to treat effectively. At the 2018 Annual North American Society for Pediatric Gastroenterology, Hepatology and Nutrition meeting, the Neurogastroenterology and Motility Committee held a full day symposium entitled, 2018 Advances In Motility and In NeuroGastroenterology - AIMING for the future. The symposium aimed to explore clinical paradigms in pediatric gastrointestinal motility disorders and provided a foundation for advancing new scientific and therapeutic research strategies. METHODS The symposium brought together leading experts throughout North America to review the state of the art in the diagnosis and management of motility and functional disorders in children. Presentations were divided into esophageal, antral duodenal, and colorectal modules. Each module included oral presentations by experts in the respective fields, leading to thought-provoking discussions. There were 2 breakout sessions with small group discussions on select topics, focusing on defining scientific insights into the diagnosis and management of pediatric functional gastrointestinal and motility disorders in a systematic, segment-based approach. CONCLUSIONS The field of neurogastroenterology has made remarkable progress in the last decade. The current report summarizes the major learning points from the symposium highlighting the diagnosis and promising therapies on the horizon for pediatric neurogastrointestinal and motility disorders.

Constipation and fecal incontinence are commonly encountered complaints in the gastrointestinal clinic. Assessment of anorectal function includes comprehensive history, rectal examination, and prospective stool diary or electronic App diary that accurately captures bowel symptoms, evaluation of severity, and quality of life of measure. Evaluation of a suspected patient with dyssynergic constipation includes anorectal manometry, balloon expulsion test, and defecography. Investigation of a suspected patient with fecal incontinence includes high-resolution anorectal manometry; anal ultrasound or MRI; and neurophysiology tests, such as translumbosacral anorectal magnetic stimulation or pudendal nerve latency. This article provides an approach to the assessment of anorectal function.

INTRODUCTION Treatments for fecal incontinence (FI) remain unsatisfactory because they do not remedy the underlying multifactorial dysfunction(s) including anorectal neuropathy. The aim of this study was to investigate the optimal dose frequency, clinical effects, and safety of a novel treatment, translumbosacral neuromodulation therapy (TNT), aimed at improving neuropathy. METHODS Patients with FI were randomized to receive 6 sessions of weekly TNT treatments consisting of 600 repetitive magnetic stimulations over each of 2 lumbar and 2 sacral sites with either 1, 5, or 15 Hz frequency. Stool diaries, FI severity indices, anorectal neurophysiology and sensorimotor function, and quality of life were compared. Primary outcome measure was the change in FI episodes/week. Responders were patients with ≥50% decrease in weekly FI episodes. RESULTS Thirty-three patients with FI participated. FI episodes decreased significantly (∆ ±95% confidence interval, 4.2 ± 2.8 (1 Hz); 2 ± 1.7 (5 Hz); 3.4 ± 2.5 (15 Hz); P < 0.02) in all 3 groups when compared with baseline. The 1 Hz group showed a significantly higher (P = 0.04) responder rate (91 ± 9.1%) when compared with the 5 Hz group (36 ± 18.2%) or 15 Hz (55 ± 18.2%); no difference was found between the 5 and 15 Hz groups (P = 0.667). Anal neuropathy, squeeze pressure, and rectal capacity improved significantly only in the 1 Hz (P < 0.05) group compared with baseline, but not in other groups. Quality of life domains improved significantly (P < 0.05) with 1 and 5 Hz groups. No device-related serious adverse events were noted. DISCUSSION TNT significantly improves FI symptoms in the short term, and the 1 Hz frequency was overall better than 5 and 15 Hz. Both anorectal neuropathy and physiology significantly improved, demonstrating mechanistic improvement. TNT is a promising, novel, safe, efficacious, and noninvasive treatment for FI (see Visual Abstract, Supplementary Digital Content 3, http://links.lww.com/AJG/B598).

Anorectal disorders encompass structural, neuromuscular, and functional disorders. They are common, often distressing, and in some cases debilitating, and significantly add to the health care burden. They present with multiple, overlapping symptoms that can often obscure the underlying pathology and can pose significant diagnostic and management dilemmas. A meticulous history and comprehensive digital rectal examination can provide clarity on the diagnosis, appropriate testing, and management of these conditions. Today, with the development of sophisticated diagnostic tools such as high-resolution and high-definition (3-D) anorectal manometry, 3-D anal ultrasonography, magnetic resonance defecography and imaging, and neurophysiological tests such as translumbosacral anorectal magnetic stimulation, it is possible to more accurately define and characterize the underlying structural and functional abnormalities. In this review, we present a succinct update on the latest knowledge with regards to the pathophysiology, diagnosis and management of anal fissure, hemorrhoids, rectal prolapse, intussusception, rectocele, solitary rectal ulcer syndrome, levator ani syndrome, dyssynergic defecation and fecal incontinence.

Background & Aims Whether gastric emptying tests predict longitudinal outcomes in patients with symptoms of gastroparesis is unclear. We aimed to determine whether baseline gastric emptying tests and gut motility parameters could impact longitudinal symptom(s) and quality of life (QOL) in a prospective, observational cohort study of patients with symptoms of gastroparesis. Methods One hundred fifty patients with gastroparesis symptoms underwent simultaneous scintigraphy (GES) and wireless motility capsule (WMC) measurement of gastric emptying and other motility parameters. Patient Assessment of Upper Gastrointestinal Symptoms and Quality of Life were administered at baseline, and 3 and 6 months after testing. Multivariable generalized linear marginal models were fit to determine which baseline parameters predict longitudinal changes in symptoms and QOL. Results Overall upper GI symptoms and QOL scores were moderate in severity at baseline and significantly improved over 6 months. Clinical variables, including female gender, harder stools by Bristol stool form score, and presence of functional dyspepsia (FD) by Rome III criteria, were predictive of more severe upper GI symptoms. Even after controlling for these clinical factors, delayed gastric emptying by GES or WMC was associated with worse symptom severity and QOL scores. Low gastric and elevated small bowel contractile parameters by WMC were also independently associated with more severe upper GI symptoms and worse QOL scores. Conclusions Baseline features, including demographic and clinical variables, delayed gastric emptying and abnormal gastrointestinal contractility, were independent predictors of more severe longitudinal symptoms and worse quality of life outcomes. These factors may help to risk stratify patients and guide treatment decisions. ClinicalTrials.gov no: NCT02022826.

Background Constipated patients remain dissatisfied with current treatments suggesting a need for alternative therapies. Aim Evaluate the mechanistic effects of oral vibrating capsule in chronic idiopathic constipation (CIC) by examining the temporal relationships between the onset of vibrations, complete spontaneous bowel movements (CSBM), and circadian rhythm. Methods In post hoc analyses of two double-blind studies, CIC patients (Rome III) were randomized to receive 5 active or sham capsules/week for 8 weeks. The capsules were programmed for single vibration (study 1) or two vibration sessions with two modes, 8 hours apart (study 2). Daily electronic diaries assessed stool habit and percentage of CSBMs associated with vibrations. Responders were patients with ≥ 1 CSBM per week over baseline. Results 250 patients were enrolled (active = 133, sham = 117). During and within 3 hours of vibration, there were significantly more % CSBMs in the active vs. sham group (50% vs. 42%; P = .0018). In study 2, there were two CSBM peaks associated with vibration sessions. Significantly more % CSBMs occurred in active mode 1 (21.5%) vs. sham (11.5%); (P = .0357). Responder rates did not differ in study 1 (active vs. sham: 26.9% vs. 35.9%, P = .19) or study 2 (mode 1 vs. sham: 50% vs. 31.8%, P = .24; mode 2 vs. sham: 38.1% vs. 31.8%, P = .75). Device was well-tolerated barring mild vibration sensation. Conclusions Vibrating capsule may increase CSBMs possibly by enhancing the physiologic effects of waking and meals, and augmenting circadian rhythm, although responder rate was not different from sham. Two vibration sessions were associated with more CSBMs.

Constipation is a multifactorial disorder that can cause significant psychological distress to patients and economic burden on the health care system. Many patients are not satisfied with their current established treatment, highlighting the need for new and improved therapeutic options. Guanylate cyclase-C (GC-C)/cyclic guanosine monophosphate agonists have emerged as a safe and efficacious class of drugs for the treatment of chronic idiopathic constipation (CIC). Plecanatide, a second-in-class, US FDA-approved, synthetic GC-C agonist, has recently been approved in the US for the treatment of irritable bowel syndrome with constipation at doses of 3 and 6 mg and CIC at the 3 mg dosage. In this study, we summarize the design of this novel 16-amino acid uroguanylin analog, drug development through Phase I, II, and III clinical studies, and its role in the treatment of CIC.

Background: Office-based biofeedback therapy is effective for constipation with dyssynergic defecation, but must be performed by skilled staff, is only available in selected centres, and requires multiple visits. The efficacy of home-based biofeedback therapy is unknown. We compared clinical and subjective outcomes with home-based and office-based approaches. Methods: In this randomised controlled trial, eligible patients were adult outpatients (age 18–80 years) who met the Rome III criteria for functional constipation and who had been referred to a tertiary-care centre after non-response to routine management, and who had dyssynergic defecation. Patients were randomly assigned according to a schedule generated in advance by the study biostatistician, in permuted blocks of four, to receive office-based or home-based biofeedback therapy. Office-based biofeedback comprised therapist-guided pelvic floor training for six sessions over 3 months (visits every 2 weeks). Home-based biofeedback comprised 20 min self-training sessions twice per day, in which a self-inserted probe was used to provide visual feedback via a handheld monitoring device of anal sphincter pressure and push effort. Patients recorded in diaries the time of each defecation attempt, stool consistency, straining effort, feeling of incomplete evacuation, need for digital assistance with stooling, and satisfaction with bowel function, from 1 week before enrolment to the end of follow-up. Treatment responders were defined post hoc as those with normalisation of dyssynergic defecation and an increase in the number of complete spontaneous bowel movements per week by 3 months. Cost outcomes calculated from health-care costs and loss of salary were assessed from hospital billing and medical records and questionnaires. Primary outcome measures were the presence of a dyssynergic pattern during attempted defecation, balloon expulsion time, the number of complete spontaneous bowel movements per week, and satisfaction with bowel function, assessed by intention to treat (non-inferiority) and per protocol. This trial is registered with ClinicalTrials.gov, number NCT03202771. Findings: Of 300 patients screened we enrolled 100, from Jan 7, 2005, to Jan 31, 2010. 83 patients completed training (38 [76%] of 50 in the home-based biofeedback group and 45 [90%] of 50 in the office-based biofeedback group). 34 (68%) patients in the home-based group and 35 (70%) in the office-based group were classified as responders. All primary outcomes improved significantly from baseline in the two treatment groups (all p

Background/Aims Whether high-resolution anorectal pressure topography (HRPT), having better fidelity and spatio-temporal resolution is comparable to waveform manometry (WM) in the diagnosis and characterization of defecatory disorders (DD) is not known. Methods Patients with chronic constipation (Rome III) were evaluated for DD with HRPT and WM during bearing-down “on-bed” without inflated rectal balloon and “on-commode (toilet)” with 60-mL inflated rectal balloon. Eleven healthy volunteers were also evaluated. Results Ninety-three of 117 screened participants (F/M = 77/16) were included. Balloon expulsion time was abnormal (> 60 seconds) in 56% (mean 214.4 seconds). A modest correlation between HRPT and WM was observed for sphincter length (R = 0.4) and likewise agreement between dyssynergic subtypes (κ = 0.4). During bearing down, 2 or more anal pressure-segments (distal and proximal) could be appreciated and their expansion measured with HRPT but not WM. In constipated vs healthy participants, the proximal segment was more expanded (2.0 cm vs 1.0 cm, P = 0.003) and of greater pressure (94.8 mmHg vs 54.0 mmHg, P = 0.010) during bearing down on-commode but not on-bed. Conclusions Because of its better resolution, HRPT may identify more structural and functional abnormalities including puborectal dysfunction (proximal expansion) than WM. Bearing down on-commode with an inflated rectal balloon may provide additional dimension in characterizing DD.

Symptoms related to abnormal gastrointestinal motility and function are common. Oropharyngeal and oesophageal dysphagia, heartburn, bloating, abdominal pain and alterations in bowel habits are among the most frequent reasons for seeking medical attention from internists or general practitioners and are also common reasons for referral to gastroenterologists and colorectal surgeons. However, the nonspecific nature of gastrointestinal symptoms, the absence of a definitive diagnosis on routine investigations (such as endoscopy, radiology or blood tests) and the lack of specific treatments make disease management challenging. Advances in technology have driven progress in the understanding of many of these conditions. This Review serves as an introduction to a series of Consensus Statements on the clinical measurements of gastrointestinal motility, function and sensitivity. A structured, evidence-based approach to the initial assessment and empirical treatment of patients presenting with gastrointestinal symptoms is discussed, followed by an outline of the contribution of modern physiological measurement on the management of patients in whom the cause of symptoms has not been identified with other tests. Discussions include the indications for and utility of high-resolution manometry, ambulatory pH-impedance monitoring, gastric emptying studies, breath tests and investigations of anorectal structure and function in day-to-day practice and clinical management.

Introduction: Although neurogastroenterology and motility (NGM) disorders affect 50% of patients seen in clinics, many gastroenterologists receive limited NGM training. One-month apprenticeship-based NGM training has been provided at ten centers in the USA for a decade, however, outcomes of this training are unclear. Our goal was to describe the effectiveness of this program from a trainees perspective.Areas Covered: We describe the training model, learning experiences, and outcomes of one-month apprenticeship-based training in NGM at a center of excellence, using a detailed individual observer account and data from 12 consecutive trainees that completed the program. During a one-month training period, 302 procedures including; breath tests (BT) n=132, anorectal manometry (ARM) n=29 and esophageal manometry (EM) n=28, were performed. Post-training, all trainees (n=12) knew indications for motility tests, and the majority achieved independence in basic interpretation of BT, EM and ARM. Additionally, in a multiple-choice NGM written-test paper, trainees achieved significant improvements in test scores post-training (P=0.003).Expert Commentary: One-month training at a high-volume center can facilitate rapid learning of NGM and the indications, basic interpretation and utility of motility tests. Trainees demonstrate significant independence, and this training model provides an ideal platform for those interested in sub-specialty NGM.

Anorectal disorders are common and present with overlapping symptoms. They include several disorders with both structural and functional dysfunction(s). Because symptoms alone are poor predictors of the underlying pathophysiology, a diagnosis should only be made after evaluating symptoms and physiologic and structural abnormalities. A detailed history, a thorough physical and digital rectal examination and a systematic evaluation with high resolution and/or high definition three-dimensional (3D) anorectal manometry, 3D anal ultrasonography, magnetic resonance defecography and neurophysiology tests are essential to correctly identify these conditions. These physiological and imaging tests play a key role in facilitating a precise diagnosis and in providing a better understanding of the pathophysiology and functional anatomy. In turn, this leads to better and more comprehensive management using medical, behavioral and surgical approaches. For example, patients presenting with difficult defecation may demonstrate dyssynergic defecation and will benefit from biofeedback therapy before considering surgical treatment of coexisting anomalies such as rectoceles or intussusception. Similarly, patients with significant rectal prolapse and pelvic floor dysfunction or patients with complex enteroceles and pelvic organ prolapse may benefit from combined behavioral and surgical approaches, including an open, laparoscopic, transabdominal or transanal, and/or robotic-assisted surgery. Here, we provide an update on the pathophysiology, diagnosis, and management of selected common anorectal disorders.

Background: Diarrhea-predominant irritable bowel syndrome (IBS-D) impairs patient quality of life (QOL). Rifaximin is an oral, nonsystemic antibiotic indicated for IBS-D. The objective of this secondary analysis was to evaluate rifaximin retreatment on IBS-related QOL in patients with IBS-D. Methods: Patients received open-label rifaximin 550 mg three times daily for 2 weeks. Clinical responders [simultaneously meeting weekly response criteria for abdominal pain (⩾30% improvement from baseline in mean weekly pain score) and stool consistency (⩾50% decrease from baseline in number of days/week with Bristol Stool Scale (BSS) type 6 or 7 stools) during ⩾2 of first 4 weeks posttreatment] who relapsed during an up to 18-week treatment-free observation phase were randomly assigned to receive two 2-week courses of double-blind rifaximin or placebo, separated by 10 weeks. A validated 34-item IBS-QOL questionnaire examined patient responses in 8 domains. Results: The 2579 patients receiving open-label rifaximin experienced a mean improvement from baseline in IBS-QOL overall score of 54.9%. Responders to open-label rifaximin ( n = 1074 of 2438 evaluable; 44.1%) had significantly greater improvement from baseline in IBS-QOL overall and all eight subdomain scores, including dysphoria, food avoidance, interference with activity, body image, and sexual function versus nonresponders at 4 weeks posttreatment ( n = 1364; p < 0.001 for all comparisons). A significantly greater percentage of responders to open-label rifaximin achieved the minimally clinically important difference (MCID; ⩾14-point improvement from baseline) in the overall IBS-QOL score versus nonresponders [ n = 561 (52.2%) versus n = 287 (21.0%); p < 0.0001]. Among 636 patients with IBS-D relapse, the MCID in the overall IBS-QOL score was achieved by a significantly greater percentage of patients receiving double-blind rifaximin versus placebo (38.6% versus 29.6%, respectively; p = 0.009). Conclusions: Open-label and blinded retreatment with a short course (2 weeks) of rifaximin improved IBS-QOL in patients with IBS-D [ClinicalTrials.gov identifier: NCT01543178].

Objectives: Breath tests (BTs) are important for the diagnosis of carbohydrate maldigestion syndromes and small intestinal bacterial overgrowth (SIBO). However, standardization is lacking regarding indications for testing, test methodology and interpretation of results. A consensus meeting of experts was convened to develop guidelines for clinicians and research. Methods: Pre-meeting survey questions encompassing five domains; indications, preparation, performance, interpretation of results, and knowledge gaps, were sent to 17 clinician-scientists, and 10 attended a live meeting. Using an evidence-based approach, 28 statements were finalized and voted on anonymously by a working group of specialists. Results: Consensus was reached on 26 statements encompassing all five domains. Consensus doses for lactulose, glucose, fructose and lactose BT were 10, 75, 25 and 25 g, respectively. Glucose and lactulose BTs remain the least invasive alternatives to diagnose SIBO. BT is useful in the diagnosis of carbohydrate maldigestion, methane-associated constipation, and evaluation of bloating/gas but not in the assessment of oro-cecal transit. A rise in hydrogen of ≥20 p.p.m. by 90 min during glucose or lactulose BT for SIBO was considered positive. Methane levels ≥10 p.p.m. was considered methane-positive. SIBO should be excluded prior to BT for carbohydrate malabsorption to avoid false positives. A rise in hydrogen of ≥20 p.p.m. from baseline during BT was considered positive for maldigestion. Conclusions: BT is a useful, inexpensive, simple and safe diagnostic test in the evaluation of common gastroenterology problems. These consensus statements should help to standardize the indications, preparation, performance and interpretation of BT in clinical practice and research.

Introduction Abdominal pain is the principal symptom of irritable bowel syndrome (IBS). This analysis examined abdominal pain response in adults with IBS with diarrhea (IBS-D) receiving the nonsystemic antibiotic rifaximin. Methods In the Targeted Nonsystemic Antibiotic Rifaximin Gut-Selective Evaluation of Treatment for IBS-D 3 trial, adults with IBS-D received open-label rifaximin 550 mg 3 times daily for 2 weeks, followed by the 4-week post-treatment phase assessing abdominal pain and stool consistency response. Responders were followed for up to 18 additional weeks; patients with recurrence were randomly assigned to receive two 2-week courses of double-blind rifaximin 550 mg 3 times daily or placebo, separated by 10 weeks. Analyses evaluated mean weekly improvements from baseline (e.g., ≥30%, ≥40%, and ≥50%) in abdominal pain during the 4-week post-repeat-treatment phases. Results Of the 2,438 evaluable patients, 1,384 (56.8%) had abdominal pain response to open-label rifaximin (≥30% improvement from baseline in the mean weekly abdominal pain score during ≥2 of the first 4 weeks post-treatment). Weekly decrease (improvement) in responders' mean abdominal pain score (scale range, 0-10) from baseline ranged from -2.6 to -3.3 points during the 18-week follow-up. After the first double-blind repeat treatment, a significantly higher percentage of rifaximin-treated patients were abdominal pain responders (53.9% [172/319]) vs placebo (44.4% [134/302], P = 0.02), with similar results after the second repeat treatment (52.9% [155/293] vs 44.7% [123/275], respectively, P = 0.047). A significantly higher percentage of rifaximin-treated patients were weekly abdominal pain responders for ≥50% of the 18-week double-blind repeat treatment phase (47.9% [138/288] vs 35.9% [97/270], P = 0.004). Discussion Rifaximin is efficacious in improving abdominal pain in adults with IBS-D.