Oblizajek, Nicholas R.

ABSTRACT Background Treatment options for medically‐refractory faecal incontinence ( FI )—including anorectal biofeedback, dextranomer injection, and sacral nerve stimulation—are limited and outcomes are often suboptimal. Anal or vaginal insert devices are infrequently used. Aims We evaluated the safety and effectiveness of a new anal insert device (StaySure) in patients with FI. Methods Patients with FI for ≥ 6 months and ≥ 4 moderate or large FI episodes during a 4‐week baseline entered a 2–4 week fitting/run‐in period to individualise device size (10 or 13 mm) followed by a 4‐week treatment period. Outcomes included effectiveness, safety, and quality of life (QoL). The primary outcome was the proportion achieving a ≥ 50% reduction in FI frequency. Results Of 124 enrolled patients, 98, 71, and 61 progressed through the baseline, fitting/run‐in, and treatment phases respectively, with few exclusions due to device intolerance. In the intent‐to‐treat cohort of 59 participants (93% women), mean ( SD ) number of days with FI declined from 13.2 (7.0) to 6.3 (6.9), and FI weekly episodes declined from 5.4 (6.9) to 2.1 (5.1) (69% reduction; p < 0.001) with similar results for both device sizes. The primary endpoint was achieved in 76.3% of participants; 54.2% achieved ≥ 75% reduction. The FIQoL overall score increased from a mean ( SD ) of 1.9 (0.6) to 2.3 (0.6) ( p < 0.001), indicating improved QoL . Improvements in FI frequency, FIQoL exceeded minimal clinically important difference thresholds, confirming clear clinical benefit. No treatment‐related serious adverse events were reported. Conclusions The StaySure anal insert device is safe, well tolerated, and effective in reducing FI in patients with moderate to severe symptoms refractory to conservative therapies. Trial Registration ClinicalTrials.gov identifier: NCT03898778

ABSTRACT Introduction Chronic gastroduodenal disorders remain challenging to manage, and new diagnostic approaches are needed to better delineate underlying causes and guide therapeutic decisions. Body Surface Gastric Mapping (BSGM) technologies combine high‐resolution gastric myoelectrical activity measurements with symptom and psychological profiling to provide mechanistic insights into gastric motor and sensory dysfunction. An International Working Group convened to derive the first consensus classification of BSGM phenotypes (the “Auckland Classification”). Methods A Technical Group conducted a systematic literature and clinical database review to identify objective test biomarkers and candidate disease mechanisms. Evidence was synthesized across 50 studies (primarily in gastroparesis, chronic nausea and vomiting, and functional dyspepsia), and BSGM phenotypes were mapped to existing treatment guidelines. Subsequently, iterative review and development of consensus was performed by a Consensus Group composed of international clinical experts familiar with BSGM. Eleven statements underlying the classification were then derived and circulated as a final survey to establish agreement. Results Six BSGM phenotypes were endorsed: three defined by myoelectrical abnormalities (Dysrhythmic, High Frequency, and Low Meal Response) and three by characteristic symptom associations (Sensorimotor, Continuous, and Delayed Onset Symptoms). Published studies plausibly linked these phenotypes to mechanisms including interstitial cell of Cajal depletion, vagal impairment, hypomotility, visceral hypersensitivity, gut‐brain dysregulation, and small bowel dysfunction. Phenotypes were also mapped to existing mechanism‐based treatment guidelines. Ten out of the eleven statements had > 80% agreement. Conclusions The Auckland Classification, derived by international consensus, presents a structured framework for BSGM‐defined patient phenotypes. Evidence and mechanism‐based treatment options are suggested for each phenotype to provide a foundation for research, further validation, and a pathway for integrating BSGM into clinical care.

INTRODUCTION: To perform a proof-of-concept study to evaluate the performance of individual and combined anorectal manometry and balloon expulsion testing (BET) parameters for diagnosing dyssynergic defecation (DD) using machine learning (ML). METHODS: A single gastrointestinal motility specialist assessed (2008–2018) 307 patients. A ML model was constructed on anorectal manometry/BET data. BET was weight-based in 235 patients and time-based in 72 patients. Missing data were imputed. Data were split 75% train/25% test with preprocessing performed. Five common ML models were trained, and performance was compared using receiver operating characteristic (ROC) area under the curve and accuracy based on 100 bootstrapped samples. The most accurate models were fine-tuned and evaluated on the test set. RESULTS: The median age was 40 years, body mass index 22.2 kg/m 2 , and 81% were women. Two-hundred and 22 (72.3%) patients had a clinical diagnosis of DD. Compared with patients without clinical diagnosis of DD, patients with DD had significantly lower rectoanal pressure gradient (RAG) (median −34.7 [IQR −57.1, −13.0] vs −24.6 [IQR −44.5, −2.4] mm Hg, P = 0.009) and more abnormal BET (59.5% vs 11.8%, P < 0.001). Four features were retained in the optimized model as predictors of DD: abnormal BET, greater resting anal pressure (RAP), and more negative RAG. The optimal parameter was abnormal BET ( P = 0.003), but combinations of 2 manometry results (RAP and RAG) yielded positive predictive values (PPVs) >80%. The optimized logistic regression model had an area under the curve of 0.878, with a sensitivity of 75.0% and specificity of 81.8% at a probability threshold of 0.704. DISCUSSION: Abnormal BET, or a combination of 2 manometric parameters (RAP and RAG), provides >80% positive predictive value for diagnosing DD in patients with chronic constipation.

AbstractBackground and AimsUp to 50% of patients with Parkinson disease have constipation (PD‐C), but the prevalence of defecatory disorders caused by rectoanal dyscoordination in PD‐C is unknown. We aimed to compare anorectal function of patients with PD‐C versus idiopathic chronic constipation (CC).MethodsAnorectal pressures, rectal sensation, and rectal balloon expulsion time (BET) were measured with high‐resolution anorectal manometry (HR‐ARM) in patients with PD‐C and control patients with CC, matched for age and sex.ResultsWe identified 97 patients with PD‐C and 173 control patients. Eighty‐six patients with PD‐C (89%) had early PD, and 39 (40%) had a defecatory disorder, manifest by a prolonged rectal balloon expulsion time (37 patients) or a lower rectoanal pressure difference during evacuation (2 patients). PD‐C patients with a prolonged BET had a greater anal resting pressure (p = 0.02), a lower rectal pressure increment (p = 0.005), greater anal pressure (p = 0.047), and a lower rectoanal pressure difference during evacuation (p < 0.001). Rectal sensory thresholds were greater in patients with abnormal BET.In the multivariate model comparing CC and PD‐C (AUROC = 0.76), PD‐C was associated with a lower anal squeeze increment (odds ratio [OR] for PD‐C, 0.93 [95% CI, 0.91–0.95]), longer squeeze duration (OR, 1.05 [95% CI, 1.03–1.08]), lower rectal pressure increment (OR per 10 mm Hg, 0.72 [95% CI, 0.66–0.79]), and negative rectoanal gradient during evacuation (OR per 10 mm Hg, 1.16 [95% CI, 1.08–1.26]).ConclusionsCompared with CC, PD‐C was characterized by impaired squeeze pressure, longer squeeze duration, lower increase in rectal pressure, and a more negative rectoanal gradient during evacuation.

AbstractBackgroundDiarrhea and rectal urgency are risk factors for fecal incontinence (FI). The effectiveness of bowel modifiers for improving FI is unclear.MethodsIn this double‐blind, parallel‐group, randomized trial, women with urge FI were randomly assigned in a 1:1 ratio to a combination of oral clonidine (0.1 mg twice daily) with colesevelam (1875 mg twice daily) or two inert tablets for 4 weeks. The primary outcome was a ≥50% decrease in number of weekly FI episodes.Key ResultsFifty‐six participants were randomly assigned to clonidine–colesevelam (n = 24) or placebo (n = 32); 51 (91%) completed 4 weeks of treatment. At baseline, participants had a mean (SD) of 7.5 (8.2) FI episodes weekly. The primary outcome was met for 13 of 24 participants (54%) treated with clonidine–colesevelam versus 17 of 32 (53%) treated with placebo (p = 0.85). The Bristol stool form score decreased significantly, reflecting more formed stools with clonidine–colesevelam treatment (mean [SD], 4.5 [1.5] to 3.2 [1.5]; p = 0.02) but not with placebo (4.2 [1.9] to 4.1 [1.9]; p = 0.47). The proportion of FI episodes for semiformed stools decreased significantly from a mean (SD) of 76% (8%) to 61% (10%) in the clonidine–colesevelam group (p = 0.007) but not the placebo group (61% [8%] to 67% [8%]; p = 0.76). However, these treatment effects did not differ significantly between groups. Overall, clonidine–colesevelam was well tolerated.Conclusions and InferencesCompared with placebo, clonidine–colesevelam did not significantly improve FI despite being associated with more formed stools and fewer FI episodes for semiformed stools.

AbstractBackground and AimsAlthough high‐resolution manometry (HR_ARM) is commonly used to diagnose defecatory disorders, its intraindividual day‐to‐day reproducibility is unknown. Since these measurements entail voluntary effort, this study aimed to evaluate the intraindividual day‐to‐day reproducibility of HR_ARM.MethodsIn 22 healthy women (35 years [14] mean [SD]) and 53 constipated patients (42 years [13], 46 women), the rectal balloon expulsion time (BET), and anorectal pressures were measured with HR_ARM on 2 days separated by a median (interquartile range) of 15 days (11–53) in healthy and 40 days (8–75) in constipated patients. Anorectal pressures were evaluated at rest (20 s), during squeeze, and during evacuation. Rectal sensation was also evaluated in constipated patients. The agreement between both measurements was evaluated with Lin's concordance correlation coefficient (CCC) and other tests.ResultsAmong constipated patients, the anal resting (mean CCC [95%CI] 0.62 [0.43–0.76]) and squeeze pressures (CCC 0.65 [0.47–0.79]), rectoanal gradient during evacuation (CCC 0.42 [0.17–0.62]), and rectal sensory thresholds (CCC for urgency 0.72 [0.52–0.84]) were concordant. Between days 1 and 2, one or more outcomes, characterized as normal or abnormal, differed in 79% of constipated patients, i.e., anal resting and squeeze pressures, the gradient, and the rectal BET differed in, respectively, 25%, 19%, 36%, and 10% of constipated patients. The rectal BET was prolonged in three healthy persons (both days) and either on 1 day (six patients) or 2 days (33 patients) in constipated patients.ConclusionsWhile HR_ARM variables and the BET are reproducible within healthy and constipated persons, the outcome on repeat testing differed in 79% of constipated patients.

AbstractBackgroundDuring high‐resolution anorectal manometry (HR_ARM), the raw data are converted into software‐derived summary variables (e.g., rectoanal gradient during evacuation) that capture only a snapshot of the data collected during HR_ARM and are less useful than newer indices, which are also derived from the raw data, for diagnosing defecatory disorders (DD). However, it is cumbersome and time‐consuming to extract raw data from the program and calculate such indices. This study aimed to devise a user‐friendly approach to extract anorectal pressures measured with HR_ARM.MethodsAnorectal pressures at rest, during anal squeeze, and evacuation were measured with HR_ARM in 180 women, among whom 60 each were healthy, had DD, or fecal incontinence. A reverse engineering approach extracted pressure values from color images in HR_ARM reports. The summary variables generated by the software and a reverse engineering approach were compared with Lin's concordance correlation coefficient (CCC), pairedt‐tests, and Bland–Altman's tests.ResultsAnorectal pressures summarized by the software and a reverse engineering method were highly concordant for anal resting (CCC [95% CI], 0.98 [0.97, 0.99]) and squeeze pressures (0.99 [0.99, 0.99) and the rectoanal gradient during evacuation with an empty (0.98 [0.97, 0.98]) and a filled balloon (0.99 [0.99, 0.99]). For most variables, the paired t and Bland–Altman comparisons were not significant.ConclusionsAnorectal pressures can be accurately determined from pressure topography images in HR_ARM reports. In future, this reverse engineering approach can be harnessed to compile large HR_ARM datasets across centers and to uncover newer, potentially more useful summary rectoanal pressure variables.

AbstractBackgroundThe optimal methods for measuring and analyzing anal resting and squeeze pressure with high‐resolution manometry (HRM) are unclear.MethodsAnal resting and squeeze pressures were measured with HRM in 90 healthy women, 35 women with defecatory disorders (DD), and 85 with fecal incontinence (FI). Pressures were analyzed with Manoview™ software and a customized approach. Resting pressures measured for 20, 60, and 300 s were compared. During the squeeze period, (3 maneuvers, 20 s each), the squeeze increment, which was averaged over 5, 10, 15, and 20 s, and squeeze duration were evaluated.ResultsCompared to healthy women, the anal resting pressure, squeeze pressure increment, and squeeze duration were lower in FI (p ≤ 0.04) but not in DD. The 20, 60, and 300 s resting pressures were strongly correlated (concordance correlation coefficients = 0.96–0.99) in healthy and DD women. The 5 s squeeze increment was the greatest; 10, 15, and 20 s values were progressively lower (p < 0.001). The squeeze pressure increment and duration differed (p < 0.01) among the three maneuvers in healthy and DD women but not in FI women. The upper 95th percentile limit for squeeze duration was 19.5 s in controls, 19.9 s in DD, and 19.3 s in FI. Adjusted for age, resting pressure, and squeeze duration, a greater squeeze increment was associated with a lower risk of FI versus health (OR, 0.96; 95% CI, 0.94–0.97).ConclusionsThese findings suggest that anal resting and squeeze pressures can be accurately measured over 20 s. In most patients, one squeeze maneuver is probably sufficient.