Defecatory Function Studies Using the Fecobionics Device Are Repeatable.

BACKGROUND: Only limited data exist on repeatability of anorectal studies with the established physiological and clinical technologies for assessment of anorectal function. Fecobionics is a new multi-sensor simulated feces that provide data by integrating elements from current tests. AIMS: To study repeatability of anorectal data obtained with the Fecobionics device. METHODS: We assessed the database of Fecobionics studies to determine how many repeated studies were done. From a total of 260 Fecobionics studies, 19 subjects with repeated studies using approximately the same protocol and prototype were identified. Key pressure and bending parameters were assessed and the repeatability analyzed using Bland Altman plots. Furthermore, the inter- and intra-individual coefficient of variation (CV) were computed. RESULTS: Fifteen subjects (5F/10 M) with repeated studies were normal subjects, three were patients with fecal incontinence and one subject suffered from chronic constipation. The main analysis was conducted on the cohort of normal subjects. The bias for 11 parameters were within the confidence interval, whereas two were slightly outside. The interindividual CV was lowest for the bend angle (10.1-10.7) and between 16.3 and 51.6 for the pressure parameters. The intra-individual CVs were approximately half of the inter-individual CVs, spanning from 9.7 to 27.6. CONCLUSION: All data from normal subjects were within previously defined normality. The Fecobionics data showed acceptable repeatability with bias within the confidence limits for almost all parameters. The intra-individual CV was much lower than the inter-individual CV. Dedicated large-scale studies are warranted to evaluate the influence of age, sex, and disease on repeatability as well as comparing between technologies.

The rectum, anal sphincter and puborectalis muscle show different contraction wave forms during prolonged measurement with a simulated feces.

Contractile patterns in rectum, puborectalis muscle and anal sphincter must be studied to understand defecation. Six subjects had contractile waveforms studied with Fecobionics. Symptom questionnaires, balloon expulsion test and anorectal manometry were done for reference. The Fecobionics bag was filled in rectum to urge-to-defecate volume and measurements were done for 4 h before the subjects attempted to evacuate the device. Pressures and bend angle (BA) variations were analyzed with Fast Fourier Transformation. Four normal subjects exhibited low frequency waves (< 0.06 Hz) for pressures and BA. The waves were uncoordinated between recordings, except for rear and bag pressures. Peak wave amplitudes occurred at 0.02-0.04 Hz. Pressures and the BA differed for peak 1 (p < 0.001) and peak 2 amplitudes (p < 0.005). The front pressure amplitude was bigger than the others (rear and BA, p < 0.05; bag, p < 0.005) for peak 1, and bigger than bag pressure (p < 0.005) and BA (p < 0.05) for peak 2. One subject was considered constipated with lower front pressure amplitudes compared to normal subjects and increased amplitudes for other parameters. The sixth subject was hyperreactive and differed from the other subjects. In conclusion, the rectum, anal sphincter and puborectalis muscle showed different contraction waves during prolonged measurements. The data call for larger studies to better understand normal defecation, feces-withholding patterns, and the implications on anorectal disorders.

Consistency of Feces Affects Defecatory Function.

Background/Aims: It is a common belief that constipated patients have hard feces that contributes to the difficulties defecating. To the best of our knowledge, no studies had been published on controlled evacuation of simulated feces with different consistencies. Methods: Twelve normal subjects were recruited for studies with the simulated feces device "Fecobionics" of different consistency (silicone shore 0A-40A corresponding to Bristol stool form scale types 2-4). The subjects filled out questionnaires and had the balloon expulsion test and anorectal manometry done for reference. The Fecobionics probes were inserted in rectum in random order with +20 minutes between insertions. The bag was filled to urge-to-defecate and evacuations took place in privacy. Non-parametric statistics with median and quartiles are provided. Results: One subject was excluded due to technical issues, and another had abnormal anorectal manometry-balloon expulsion test. The 4 females/6 males subjects were aged 23 (range 20-48) years. Most differences were observed between the 0A and 10A probe (duration, maximum bag pressure, duration x maximum bag pressure, and relaxation of the front pressure and the bend angle during evacuation), eg, the duration was 9 (8-12) seconds at 0A and 18 (12-21) seconds at 10A (P < 0.05), and maximum bag pressure was 107 (96-116) cmH2O at 0A and 140 (117-162) cmH2O at 10A (P < 0.05). The bend angle before evacuation differed between the probes whereas only the 10A differed from 40A during defecation. The 10A was harder to evacuate than the 0A probe. Except for the bend angles, no further significant change was observed from 10A to 40A. Conclusion: Fecal consistency affects defecatory parameters.

Feasibility study of defecation studied with a wireless Fecobionics probe in normal subjects.

Several technologies have been developed for assessing anorectal function including the act of defecation. We used a new prototype of the Fecobionics technology, a multi-sensor simulated feces, to visualize defecatory patterns and introduced new metrics for anorectal physiology assessment in normal subjects. Fourteen subjects with normal fecal incontinence and constipation questionnaire scores were studied. The 10-cm-long Fecobionics device provided measurements of axial pressures, orientation, bending, and shape. The Fecobionics bag was distended to the urge-to-defecate level inside rectum where after the subjects were asked to evacuate. Physiological evacuation parameters were assessed. Special attention was paid to the Fecobionics rectoanal pressure gradient (F-RAPG) during evacuation. Anorectal manometry (ARM) and balloon expulsion test (BET) were done as references. The user interface displayed the fine coordination between pressures, orientation, bending angle, and shape. The pressures showed that Fecobionics was expelled in 11.5 s (quartiles 7.5 and 18.8s), which was shorter than the subjectively reported expulsion time of the BET balloon. Six subjects did not expel the BET balloon within 2 min. The F-RAPG was 101 (79-131) cmH2 O, whereas the ARM-RAPG was -28 (-5 to -47) cmH2 0 (p < 0.001). There was no association between the two RAPGs (r2  = 0.19). Fecobionics showed paradoxical contractions in one subject (7%) compared to 12 subjects with ARM (86%). Fecobionics obtained novel physiological data. Defecatory patterns and data are reported and can be used to guide larger-scale studies in normal subjects and patients with defecatory disorders. In accordance with other studies, this Fecobionics study questions the value of the ARM-RAPG.

Anorectal volume-pressure relations, contraction work, and flow during defecation.

Fecobionics is an integrated device that has shown promise for assessment of anorectal function. We used a wireless Fecobionics prototype to visualize defecatory patterns and to compute volume-pressure, contraction work, and flow. Twelve normal subjects were studied. The probe was 10 cm-long and contained pressure sensors and electrodes for impedance planimetry. Pressures, diameters, and volume data during defecation were analyzed. The bag was distended inside rectum to the urge-to-defecate level where after the subjects were asked to evacuate. The contraction work and defecatory flow were computed from the volume changes during expulsion. The minimum anal diameter during the evacuation was 17.6 ± 1.5 mm. The middle diameter recording was 10-20% lower than the front diameter channels and 10-20% bigger than the rear channels. The bag volume at urge correlated with the minimum diameter (r = 0.63). The diameter-pressure and volume-pressure loops were counterclockwise with phases of bag filling, isometric contraction, ejection and anal passage. The defecatory contraction work was 3520 ± 480 mL × cmH2O. The maximum flow during defecation was 302 ± 33 mL/s. The flow was associated with the anal diameter (r = 0.84) but not with the rectoanal pressure gradient (r = 0.14). Volume-pressure loops have a tremendous impact on the understanding of cardiopulmonary pathophysiology. Future studies will shed light on potential clinical impact in defecatory pathophysiology.

New developments in defecatory studies based on biomechatronics.

Introduction: Defecation is a complex process that is difficult to study and analyze directly. In anorectal disease conditions, the defecation process may be disturbed, resulting in symptoms including fecal incontinence and constipation. Current state-of-the-art technology measures various aspects of anorectal function but detailed analysis is impossible because they are stand-alone tests rather than an integrated multi-dimensional test. Objectives: The need for physiologically-relevant and easy-to-use diagnostic tests for identifying underlying mechanisms is substantial. We aimed to advance the field with integrated technology for anorectal function assessment. Methods: We developed a simulated stool named Fecobionics that integrates several tests to assess defecation pressures, dimensions, shape, orientation and bending during evacuation. A novelty is that pressures are measured in axial direction, i.e. in the direction of the trajectory. Using this novel tool, we present new analytical methods to calculate physiologically relevant parameters during expulsion in normal human subjects. Results: Data are reported from 28 human subjects with progressively more advanced versions of Fecobionics. A new concept utilizes the rear-front pressure (preload-afterload) diagram for computation of novel defecation indices. Fecobionics obtained physiological data that cannot be obtained with current state-of-the-art technologies. Conclusion: Fecobionics measures well known parameters such as expulsion time and pressures as well as new metrics including defecation indices. The study suggests that Fecobionics is effective in evaluation of key defecatory parameters and well positioned as an integrated technology for assessment of anorectal function and dysfunction.

Pathophysiology and treatment of achalasia in a muscle mechanical perspective.

This review provides a biomechanical perspective on the pathophysiology and treatment of achalasia. The esophagus is efficient in transporting ingested material to the stomach in healthy subjects. A fine balance exists between the peristaltic forces generated in the esophageal body (which herein is defined as the preload) and the resistance in the outlet, the esophago-gastric junction (which is defined as the afterload). Achalasia is a rare esophageal disease that progressively over many years challenges esophageal efficacy. Clinical features and current literature are interpreted using well-known muscle mechanics models and terms from cardiac mechanophysiology. The preload, afterload, length-tension, and strain softening concepts in particular are useful for understanding the remodeling induced by achalasia. The concepts are also useful in understanding the treatment that aim to reduce the lower esophageal sphincter pressure that does not relax sufficiently in achalasia. These treatments cover endoscopic or laparoscopic myotomy, pneumatic balloon dilation, and Botox injections. In addition to the intended reduction of the afterload for aboral transport of ingested materials, the treatments tend to induce gastroesophageal reflux in some patients because they obliterate an important component in the reflux barrier.

What Is the Future of Impedance Planimetry in Gastroenterology?

The gastrointestinal (GI) tract is efficient in transporting ingested material to the site of delivery in healthy subjects. A fine balance exists between peristaltic forces, the mixing and delivery of the contents, and sensory signaling. This fine balance is easily disturbed by diseases. It is mandatory to understand the pathophysiology to enhance our understanding of GI disorders. The inaccessibility and complex nervous innervation, geometry and mechanical function of the GI tract make mechanosensory evaluation difficult. Impedance planimetry is a distension technology that assesses luminal geometry, mechanical properties including muscle dynamics, and processing of nociceptive signals from the GI tract. Since standardized models do not exist for GI muscle function in vivo, models, concepts, and terminology must be borrowed from other medical fields such as cardiac mechanophysiology. The review highlights the impedance planimetric technology, muscle dynamics assessment, and 3 applied technologies of impedance planimetry. These technologies are the multimodal probes that assesses sensory function, the functional luminal imaging probe that dynamically measures the geometry of the lumen it distends, and Fecobionics that is a simulated feces providing high-resolution measurements during defecation. The advanced muscle analysis and 3 applied technologies can enhance the quality of future interdisciplinary research for gaining more knowledge about mechanical function, sensory-motor disorders, and symptoms. This is a step in the direction of individualized treatment for GI disorders based on diagnostic subtyping. There seems to be no better alternatives to impedance planimetry, but only the functional luminal imaging probe is currently commercially available. Wider use depends on commercialization of the multimodal probe and Fecobionics.