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BACKGROUND: Irritable bowel syndrome (IBS), defined according to the Rome IV diagnostic criteria, is a chronic functional gastrointestinal disorder characterized by recurrent abdominal pain related to altered bowel habits. First-line recommended treatments are limited to combining drugs targeting predominant symptoms, particularly pain (antispasmodics), constipation (laxatives), and diarrhea (loperamide), yielding only a limited therapeutic gain. GASTRAP® DIRECT is a class IIa medical formulation composed of a combination of chitin-glucan and simethicone indicated for the symptomatic treatment of gas-related gastrointestinal disorders by combining different mechanisms of action. AIM: To evaluate the efficacy, tolerability, and safety of 4-week GASTRAP® DIRECT treatment in patients with IBS. METHODS: In this prospective, multicenter, open-label trial, 120 patients with IBS received three sticks of GASTRAP® DIRECT (1.5 g/d of chitin-glucan and 0.75 mg/d of simethicone) per day for 4 weeks. The primary endpoint was the responder rate, defined as the number of patients whose abdominal pain score decreased by ≥ 30% from baseline to week (W) 4. The analysis was performed using the per-protocol set. Cardinal symptoms, impact of global symptoms on daily life, change in stool consistency, and improvement in defecatory disorders were evaluated. RESULTS: Overall, 100 patients were evaluated. At W4, 67% (95%CI: 57-75) showed improvement in abdominal pain (score: 5.8 ± 2.4 vs 2.9 ± 2.0, P < 0.0001). Similar improvements were observed for bloating [8.0 ± 1.7 vs 4.7 ± 2.9, P < 0.0001; 60% (95%CI: 50-70) responders], abdominal distension [7.2 ± 2.1 vs 4.4 ± 3.1, P < 0.0001; 53% (95%CI: 43-63) responders], and impact of global symptoms on daily life [7.1 ± 2.0 vs 4.6 ± 2.9, P < 0.0001; 54% (95%CI: 44-64) responders]. Stool consistency improved in most patients (90% and 57% for patients with liquid and hard stools, respectively). Overall, 42% of patients with defecatory disorders reported very much/considerable improvements by W2. No severe adverse event occurred, and tolerability was rated "good" or "very good" by 93% of patients. CONCLUSION: GASTRAP® DIRECT is safe and well tolerated, alleviating IBS symptoms rapidly in 2 weeks. This open-label study suggests that the combination of chitin-glucan and simethicone could be beneficial in patients with IBS.

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BACKGROUND: Whether patients with defecatory disorders (DDs) with favorable response to a footstool have distinctive anorectal pressure characteristics is unknown. We aimed to identify the clinical phenotype and anorectal pressure profile of patients with DDs who benefit from a footstool. METHODS: This is a retrospective review of patients with high resolution anorectal manometry (HR-ARM) and balloon expulsion test (BET) from a tertiary referral center. BET was repeated with a 7-inch-high footstool in those who failed it after 120 s. Data were compared among groups with respect to BET results. KEY RESULTS: Of the 667 patients with DDs, a total of 251 (38%) had failed BET. A footstool corrected BET in 41 (16%) of those with failed BET. Gender-specific differences were noted in anorectal pressures, among patients with and without normal BET, revealing gender-based nuances in pathophysiology of DDs. Comparing patients who passed BET with footstool with those who did not, the presence of optimal stool consistency, with reduced instances of loose stools and decreased reliance on laxatives were significant. Additionally, in women who benefited from a footstool, lower anal pressures at rest and simulated defecation were observed. Independent factors associated with a successful BET with a footstool in women included age <50, Bristol 3 or 4 stool consistency, lower anal resting pressure and higher rectoanal pressure gradient. CONCLUSION & INFERENCES: Identification of distinctive clinical and anorectal phenotype of patients who benefited from a footstool could provide insight into the factors influencing the efficacy of footstool utilization and allow for an individualized treatment approach in patients with DDs.

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Vascular approach during elective laparoscopic left colectomy impacts post-operative outcomes. The aim of our study was to evaluate how different approaches impact positively defecatory, urinary and sexual functions and quality of life during elective laparoscopic left colectomy. A prospective non-randomized controlled trial at two tertiary center was conducted. All patients who underwent elective laparoscopic left colonic resection from January 2019 to July 2022 were analyzed. They were divided into two groups based on Inferior Mesenteric Artery (IMA) preservation with distal ligation of sigmoid branches close to a colonic wall for complicated diverticular disease and IMA high tie ligation for oncological disease. Patients were asked to fulfil standardized, validated questionnaires to evaluate pre and post-operative defecatory, urinary and sexual functions and quality of life. Defecatory disorders were assessed by high-resolution anorectal manometry preoperatively and six months after surgery. A total of 122 patients were included in the study. The 62 patients with IMA preservation showed a lower incidence of defecatory disorders also confirmed by manometer data, minor incontinence and less lifestyle alteration than the 60 patients with IMA high tie ligation. No urinary disorders such as incomplete emptying, frequency, intermittence or urgency were highlighted after surgery in the IMA preservation group. Evidence of any sexual disorders remained controversial. The IMA-preserving vascular approach seems to be an effective strategy to prevent postoperative functional disorders. It is a safe and feasible technique especially for diverticular disease. New prospective randomized and highly probative studies are needed to confirm the effectiveness in specific clinical situations.

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Introduction: Gastrointestinal dysfunction, particularly constipation, is among the most common non-motor manifestations in Parkinson's Disease (PD). We aimed to identify high-resolution anorectal manometry (HR-ARM) abnormalities in patients with PD using the London Classification. Methods: We conducted a retrospective review of all PD patients at our institution who underwent HR-ARM and balloon expulsion test (BET) for evaluation of constipation between 2015 and 2021. Using age and sex-specific normal values, HR-ARM recordings were re-analyzed and abnormalities were reported using the London Classification. A combination of Wilcoxon rank sum and Fisher's exact test were used. Results: 36 patients (19 women) with median age 71 (interquartile range [IQR]: 69-74) years, were included. Using the London Classification, 7 (19%) patients had anal hypotension, 17 (47%) had anal hypocontractility, and 3 women had combined hypotension and hypocontractility. Anal hypocontractility was significantly more common in women compared to men. Abnormal BET and dyssynergia were noted in 22 (61%) patients, while abnormal BET and poor propulsion were only seen in 2 (5%). Men had significantly more paradoxical anal contraction and higher residual anal pressures during simulated defecation, resulting in more negative recto-anal pressure gradients. Rectal hyposensitivity was seen in nearly one third of PD patients and comparable among men and women. Conclusion: Our data affirms the high prevalence of anorectal disorders in PD. Using the London Classification, abnormal expulsion and dyssynergia and anal hypocontractility were the most common findings in PD. Whether the high prevalence of anal hypocontractility in females is directly related to PD or other confounding factors will require further research.

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BACKGROUND: Functional defecatory disorders (FDDs) are highly prevalent around the world. Biofeedback is an effective treatment for FDDs. Traditionally, this treatment is performed by clinicians in a limited number of hospitals because of procedure-related expenses and a need for a dedicated procedure room. To make the biofeedback therapy more widely available, we have designed a novel wireless, smartphone-based biofeedback device, with the ultimate goal of performing the therapy at home. The aim of this pilot study was to investigate whether the developed device can be employed to treat patients with FDDs in a clinical setting, prior to employing it in a home setting. METHODS: From March 2018 to July 2018, we performed the biofeedback therapy using the newly developed wireless, smartphone-based device in patients with FDDs 30 min daily during weekdays for 2 weeks. A Visual Analogue Scale (VAS) for bowel satisfaction, Patient Assessment of Constipation-Symptoms (PAC-SYM), Patient Assessment of Constipation Quality of Life (PAC-QOL), and a balloon expulsion test were assessed at baseline and after the therapy. RESULTS: Thirteen patients were recruited and ten of them (mean age 70.3 ± 8.9 years, female:male ratio: 3:7) completed the study. Spontaneous bowel movements, complete spontaneous bowel movements, and VAS were all significantly increased after the therapy compared with baseline, respectively (6.5 ± 4.3 vs. 1.5 ± 2.2, p = 0.006; 3.1 ± 2.2 vs. 0.2 ± 0.6, p = 0.002; 49.5 ± 31.0 vs. 12.0 ± 9.2, p = 0.003). There was a significant decrease in the PAC-SYM and PAC-QoL after the biofeedback therapy (0.7 ± 0.6 vs. 1.4 ± 0.3, p = 0.001; 0.7 ± 0. 6 vs. 1.5 ± 0.4, p = 0.001). The therapy reduced the balloon expulsion time significantly (83.9 ± 68.8 s vs. 160.0 ± 36.7 s, p = 0.002). No obvious adverse events related to the procedure itself occurred. CONCLUSIONS: Biofeedback training using the newly developed wireless, smartphone-based device is feasible in the clinic setting, and it seems to be a promising method for improving constipation and related symptoms in patients with FDDs. These findings could be used to develop a much-needed, home-based, suitably powered, randomized, controlled clinical trial.

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BACKGROUND: There are little data evaluating the performance of the 3-dimensional high-definition anorectal manometry (3D-HDAM) system in the diagnosis of dyssynergic defecation. Physical properties of the thicker, rigid, 3D-HDAM probe may have implications on the measurements of anorectal pressures. AIM: Our aim was to compare 3D-HDAM to balloon expulsion test and magnetic resonance (MR) defecography. METHODS: Consecutive constipated patients referred for anorectal function testing at the Calgary Gut Motility Centre (Calgary, Canada) between 2014 and 2019 were assessed. All patients underwent anorectal manometry with the 3D-HDAM probe, and a subset underwent BET or MR defecography. Anorectal manometric variables were compared between patients who had normal and abnormal BET. RESULTS: Over the study period, 81 patients underwent both 3D-HDAM and BET for symptoms of constipation. 52 patients expelled the balloon within 3 minutes. Patients with abnormal BET had significantly lower rectoanal pressure differential (RAPD) (-61 vs. -31 mmHg for normal BET, p = 0.03) and defecation index (0.29 vs. 0.56, p = 0.03). On logistic regression analysis, RAPD (OR: 0.99, 95% CI: 0.97-0.99, p = 0.03) remained a negative predictor of abnormal BET. On ROC analysis, RAPD had an AUC of 0.65. There was good agreement between dyssynergic patterns on 3D-HDAM and defecographic evidence of dyssynergia (sensitivity 80%, specificity 90%, PLR 9, NLR 0.22, accuracy 85%). CONCLUSIONS: Manometric parameters, when measured with the 3D-HDAM probe, poorly predict prolonged balloon expulsion time. RAPD remains the best predictor of prolonged balloon expulsion time. The 3D-HDAM probe may not be the ideal tool to diagnose functional defecatory disorders.

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Fecal incontinence is a highly prevalent and debilitating condition that negatively impacts quality of life. The etiology is often multifactorial and treatment can be hindered by lack of understanding of its mechanisms and available treatment options. This article reviews the evidence-based update for the management of fecal incontinence.

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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 s). 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 (e.g., 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.

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Refractory constipation usually refers to constipation with no response to 4 weeks of drug treatment or 3 months of pelvic floor biofeedback training. Chronic constipation is a common disease mainly affecting middle-aged and elderly individuals. However, less than 20% of the patients have received clinical evaluation and systematic intervention. According to the symptoms and results of anorectal function test, patients with chronic constipation can be generally classified as functional constipation, irritable bowel syndrome with constipation and defecatory disorders. This article made a brief summary on the clinical evaluation and drug therapy of refractory constipation.

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BACKGROUND: High-resolution manometry (HRM) is used to measure rectoanal pressures in defecatory disorders and fecal incontinence. This study sought to define normal values for rectoanal HRM, ascertain the effects of age and BMI on rectoanal pressures, and compare pressures in asymptomatic women with normal and prolonged balloon expulsion time (BET). METHODS: High-resolution manometry pressures and BET were measured in 163 asymptomatic healthy participants. Women (96) and men (47) with normal BET were used to estimate normal values and the effects of age/BMI on pressures using a Medtronic 4.2-mm-diameter rectoanal catheter. KEY RESULTS: Age is associated with lower resting pressure, higher rectal pressure during evacuation, and a higher rectoanal gradient during evacuation in women and men. In women, the BET is also inversely correlated with age while the BMI is correlated with a higher threshold volume for discomfort and a longer BET. The anal squeeze pressure increment, squeeze duration, and HPZ length are higher in men than women. The rectoanal gradient during evacuation is also lower (ie, more negative) in asymptomatic women with an abnormal than a normal BET. CONCLUSIONS & INFERENCES: These findings provide an expanded database of normal values for anorectal HRM in men and women. Age and sex affect anal resting and squeeze pressures, respectively; rectal pressure during evacuation is also higher in older people. Less than 15% of asymptomatic people have BET >60 seconds, which is associated with manometry features of impaired evacuation.

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BACKGROUND: During proctography, rectal emptying is visually estimated by the reduction in rectal area. The correlation between changes in rectal area, which is a surrogate measure of volume, is unclear. Our aims were to compare the change in rectal area and volume during magnetic resonance (MR) proctography and to compare these parameters with rectal balloon expulsion time (BET). METHODS: In 49 healthy and 46 constipated participants, we measured BET and rectal area and volume with a software program before and after participants expelled rectal gel during proctography. KEY RESULTS: All participants completed both tests; six healthy and 17 constipated patients had a prolonged (>60 seconds) BET. During evacuation, the reduction in rectal area and volume was lower in participants with an abnormal than a normal BET (P < 0.01). The reduction in rectal area and volume were strongly correlated (r = 0.93, P < 0.001) and equivalent for identifying participants with abnormal BET. Among participants with less evacuation, the reduction in rectal area underestimated the reduction in rectal volume. A rectocele larger than 2 cm was observed in eight of 18 (44%) participants in whom the difference between change in volume and area was ˃10% but only 14 of 77 (18%) participants in whom the difference was ≤10% (P = 0.03). CONCLUSIONS: Measured with MR proctography, the rectal area is reasonably accurate for quantifying rectal emptying and equivalent to rectal volume for distinguishing between normal and abnormal BET. When evacuation is reduced, the change in rectal area may underestimate the change in rectal volume.

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The purpose of this clinical practice update expert review is to describe the key principles in the use of surgical interventions and device-aided therapy for managing fecal incontinence (FI) and defecatory disorders. The best practices outlined in this review are based on relevant publications, including systematic reviews and expert opinion (when applicable). Best Practice Advice 1: A stepwise approach should be followed for management of FI. Conservative therapies (diet, fluids, techniques to improve evacuation, a bowel training program, management of diarrhea and constipation with diet and medications if necessary) will benefit approximately 25% of patients and should be tried first. Best Practice Advice 2: Pelvic floor retraining with biofeedback therapy is recommended for patients with FI who do not respond to the conservative measures indicated above. Best Practice Advice 3: Perianal bulking agents such as intra-anal injection of dextranomer may be considered when conservative measures and biofeedback therapy fail. Best Practice Advice 4: Sacral nerve stimulation should be considered for patients with moderate or severe FI in whom symptoms have not responded after a 3-month or longer trial of conservative measures and biofeedback therapy and who do not have contraindications to these procedures. Best Practice Advice 5: Until further evidence is available, percutaneous tibial nerve stimulation should not be used for managing FI in clinical practice. Best Practice Advice 6: Barrier devices should be offered to patients who have failed conservative or surgical therapy, or in those who have failed conservative therapy who do not want or are not eligible for more invasive interventions. Best Practice Advice 7: Anal sphincter repair (sphincteroplasty) should be considered in postpartum women with FI and in patients with recent sphincter injuries. In patients who present later with symptoms of FI unresponsive to conservative and biofeedback therapy and evidence of sphincter damage, sphincteroplasty may be considered when perianal bulking injection and sacral nerve stimulation are not available or have proven unsuccessful. Best Practice Advice 8: The artificial anal sphincter, dynamic graciloplasty, may be considered for patients with medically refractory severe FI who have failed treatment or are not candidates for barrier devices, sacral nerve stimulation, perianal bulking injection, sphincteroplasty and a colostomy. Best Practice Advice 9: Major anatomic defects (eg, rectovaginal fistula, full-thickness rectal prolapse, fistula in ano, or cloaca-like deformity) should be rectified with surgery. Best Practice Advice 10: A colostomy should be considered in patients with severe FI who have failed conservative treatment and have failed or are not candidates for barrier devices, minimally invasive surgical interventions, and sphincteroplasty. Best Practice Advice 11: A magnetic anal sphincter device may be considered for patients with medically refractory severe FI who have failed or are not candidates for barrier devices, perianal bulking injection, sacral nerve stimulation, sphincteroplasty, or a colostomy. Data regarding efficacy are limited and 40% of patients had moderate or severe complications. Best Practice Advice 12: For defecatory disorders, biofeedback therapy is the treatment of choice. Best Practice Advice 13: Based on limited evidence, sacral nerve stimulation should not be used for managing defecatory disorders in clinical practice. Best Practice Advice 14: Anterograde colonic enemas are not effective in the long term for management of defecatory disorders. Best Practice Advice 15: The stapled transanal rectal resection and related procedures should not be routinely performed for correction of structural abnormalities in patients with defecatory disorders.

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AIMS: To determine if fecal incontinence (FI) is associated with constipation and defecatory symptoms in women with urinary incontinence, fecal incontinence, and pelvic organ prolapse. METHODS: Cross-sectional study of women seeking care for urinary incontinence, fecal incontinence, and pelvic organ prolapse. FI was defined as a positive response to the question, "During the last 4 weeks how often have you leaked or soiled yourself with stool?" Constipation and defecatory symptoms, including straining, sensation of incomplete emptying, and splinting, were measured using the Birmingham Bowel Symptom Questionnaire and the Colorectal Anal Distress Inventory. Prevalence and severity of constipation and defecatory symptoms were compared between women with and without FI. We performed separate multivariable regression analyses for the association of FI and constipation and defecatory symptoms while adjusting for potential confounders. RESULTS: We included 1,015 women: 422 (44%) with and 593 (56%) without FI. Women with FI compared to those without FI were more likely to report constipation (76% vs. 66%) as well as straining (53% vs. 38%), sensation of incomplete emptying (58% vs. 40%) and splinting (30% vs. 20%), all P < 0.001. Women with FI reported greater severity of constipation (4.3 ± 4.3 vs. 3.1 ± 3.6, P < 0.001), straining (2.7 ± 1 vs. 2.5 ± 0.9, P = 0.02) and sense of incomplete emptying (2.6 ± 1 vs. 2.4 ± 0.9, P = 0.02) than women without FI. Even after controlling for potential confounders, the diagnosis of FI was significantly associated with constipation and defecatory symptoms. CONCLUSIONS: In women with urinary incontinence, fecal incontinence, and pelvic organ prolapse, diagnosis of FI is associated with constipation and other defecatory symptoms; which impacts evaluation and management strategies. Neurourol. Urodynam. 36:495-498, 2017. © 2016 Wiley Periodicals, Inc.

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Fecal incontinence is a highly prevalent and distressing condition that has a negative impact on quality of life. The etiology is often multifactorial, and the evaluation and treatment of this condition can be hindered by a lack of understanding of the mechanisms and currently available treatment options. This article reviews the evidence-based update for the management of fecal incontinence.

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Fecal incontinence (FI) is a physically and psychosocially debilitating disorder which negatively impacts quality of life (QOL). It bears a significant burden not only on patients but also on their families, caretakers as well as society as a whole. Even though it is considered a somewhat common condition, especially as women age, the prevalence is often underestimated due to patients' reluctance to report symptoms or seek care. The evaluation and treatment of FI can be also hindered by lack of understanding of the current management options among healthcare providers and how they impact on QOL. This article provides a comprehensive review on the impact of FI and its treatment on QOL in women.

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Obstructive defecation syndrome (ODS) is a common disorder with a considerable impact on the quality of life of affected patients. Surgery for ODS remains a challenging topic. There exists a great variety of operative techniques to treat patients with ODS. According to the surgeon's preference the approach can be transanal, transvaginal, transperineal or transabdominal. All techniques have its advantages and disadvantages. Notably, high evidence based studies are significantly lacking in literature, thus making accurate assessments difficult. Careful patient's selection is crucial to achieve optimal functional results. It is mandatory to assess not only defecation disorders but also evaluate overall pelvic floor symptoms, such as fecal incontinence and urinary disorders for choosing an appropriate and tailored strategy. Radiological investigation is essential but may not explain complaints of every patient.

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Fecal incontinence (FI) is a debilitating disorder which negatively impacts quality of life. The etiology is often multifactorial and although most women with FI are able to be treated, many remain untreated because a significant proportion of women do not report their symptoms and seek care. The evaluation and treatment of FI can be also hindered by a lack of understanding of the mechanisms and current options. This article provides a review on the evidence-based evaluation and management for FI.

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BACKGROUND: Sacral nerve stimulation (SNS) is now well established as a treatment for fecal incontinence (FI) resistant to conservative measures and may also have utility in the management of chronic constipation; however, mechanism of action is not fully understood. End organ effects of SNS have been studied in both clinical and experimental settings, but interpretation is difficult due to the multitude of techniques used and heterogeneity of reported findings. The aim of this study was to systematically review available evidence on the mechanisms of SNS in the treatment of FI and constipation. METHODS: Two systematic reviews of the literature (performed in accordance with the Preferred Reporting Items for Systematic reviews and Meta-Analyses framework) were performed to identify manuscripts pertaining to (a) clinical and (b) physiological effects of SNS during the management of hindgut dysfunction. KEY RESULTS: The clinical literature search revealed 161 articles, of which 53 were deemed suitable for analysis. The experimental literature search revealed 43 articles, of which nine were deemed suitable for analysis. These studies reported results of investigative techniques examining changes in cortical, gastrointestinal, colonic, rectal, and anal function. CONCLUSIONS & INFERENCES: The initial hypothesis that the mechanism of SNS was primarily peripheral motor neurostimulation is not supported by the majority of recent studies. Due to the large body of evidence demonstrating effects outside of the anorectum, it appears likely that the influence of SNS on anorectal function occurs at a pelvic afferent or central level.

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Solitary rectal ulcer syndrome (SRUS) is an uncommon disorder which can present in patients being evaluated for defecatory disorders or which can present as a primary process often involving hematochezia, rectal pain and tenesmus. Unfortunately the diagnosis of this disorder is often delayed due to misdiagnosis and/or physician unfamiliarity with the condition. We present a 24-year-old female who presented with 6 months of bloody diarrhea and weight loss. She had been receiving treatment for a presumed diagnosis of inflammatory bowel disease (IBD) due to an endoscopic picture of rectal thickening, edema and ulceration and had been on prednisone for 2 months prior to presentation without relief of her symptoms. After further testing including repeat endoscopy with biopsies, defecography and anorectal manometry, the diagnosis of SRUS was made and treatment was changed. Medical management was unsuccessful and she ultimately required surgical intervention. This case highlights the difficulty in diagnosing SRUS due to its resemblance to other gastrointestinal diseases and should serve as a reminder that if a patient is not responding to IBD therapy, another etiology should be considered.