Introduction

Accurate diagnosis of Pelvic Floor Disorders (PFD) requires multiple tests, including balloon expulsion, anorectal manometry, and defecography. Current diagnostic approaches have significant limitations: they require multiple visits to specialized clinics, are conducted in non-private and often embarrassing environments, and use non-physiologic (lying) positions. As a result, they (a) provide fragmented, sometimes inaccurate, and difficult-to-integrate information, and (b) are inconvenient and distressing for patients, while time-consuming for providers and payers.

Aims & Methods

To develop a novel, comprehensive, accurate, all-in-one diagnostic system to replace current multi-test approaches.
We developed a disposable balloon and catheter system capable of simultaneously measuring rectal and anal pressures and anorectal angle. These physiological metrics are recorded during balloon expulsion in a physiologic seated position. Data are transmitted via Bluetooth to a nearby computer, enabling the test to be performed in a private toilet room. The system was tested for functionality, convenience, and safety, and compared with balloon expulsion (Mui Scientific) and high-resolution manometry (HRM, ManoScan™, Medtronic) in both lying and seated positions, using standardized protocols (London and IAPWG).

Results

The Ano-Rectal Diagnostic System (ARDiS) reliably measured rectal and anal pressures in both positions, with values comparable to standard HRM. ARDiS also enabled novel assessment of anorectal angle. These parameters were recorded simultaneously in real time during seated balloon expulsion. Data transmission to a nearby laptop or office computer was seamless. The procedure was well tolerated, with no reported side effects. Patients preferred the private, seated testing environment.

Conclusion

The ARDiS system enables comprehensive, accurate, and simultaneous assessment of anorectal function in one convenient session. Designed for both hospitals and outpatient clinics, ARDiS streamlines the diagnostic process, improves patient compliance, and supports accurate diagnosis and personalized management of PFD. It may fundamentally transform clinical practice by replacing multiple fragmented tests with a single integrated solution.

Disclosure

Glukhovsky & Melamud: Shares in ARDiS Medical Ltd.
Ringel: Scientific Advisory Board, ARDiS Medical Ltd

Introduction

Previous studies have demonstrated that the Chinese population has a more stringent interpretation of “normal” defecation. The symptom spectrum of Chinese constipated patients remains unknown.

Aims & Methods

To systematically investigate the symptom spectrum of Chinese constipated patients, and to evaluate the clinical applicability of Rome IV criteria in this distinct population.

Non-selective outpatients (aged ≥16 years) self-identified with “constipation” were enrolled and given the Rome IV questionnaire. Data on demographics, defecation frequency, stool forms, defecation symptoms, and abdominal symptoms were collected. Non-constipated controls were recruited from outpatients’ family members for demographics and defecation pattern data. Descriptive analysis was performed to contrast distribution differences between constipated and normal individuals, and to determine the abnormal defecation symptom thresholds. The consistency of Rome IV criteria with respondents’ self-assessments was evaluated, and modifications of Rome IV criteria were proposed based on these thresholds.

Results

The study enrolled 6364 constipated individuals and 1432 normal controls. In constipated individuals, the prevalent symptoms included straining (97.29%), sensation of incomplete evacuation (96.07%), hard stools (95.21%), sensation of anorectal obstruction (93.22%), reduced defecation frequency (91.67%), bloating or abdominal distension (87.13%), abdominal pain (76.71%), laxative-assisted defecation (23.98%), and manipulation-assisted defecation (21.51%).
Descriptive analysis has substantiated that constipated patients exhibit inter-individual symptom heterogeneity, validating the clinical utility of Rome IV's symptom cluster-based diagnostic paradigm. However, Rome IV criteria manifested poor consistency with self-assessment (Kappa=0.24, P<0.01), with high specificity (98.81%) but low sensitivity (47.30%). This discrepancy reflects stricter perceptions of normal defecation among the Chinese.
As for normal controls, the mean defecation frequency was 7.09±2.03/week, with the 90th percentile cutoff (4/week) stricter than Rome IV's 3/week benchmark. This quantitative analysis yielded six constipation diagnostic thresholds: defecation frequency = 4 times a week, hard stools =30%, straining =30%, sensation of incomplete evacuation =20%, sensation of anorectal obstruction or blockage =10%, and manipulation-assisted defecation =10%.
We compared five diagnostic approaches to determine the optimal symptom count for constipation diagnosis. As illustrated in the Table, the diagnostic approach with the presence of ≥2 abnormal symptoms had an excellent consistency (Kappa value =0.80, P < 0.01), high specificity (95.46%), and high sensitivity (92.94%).

Conclusion

Rome IV criteria demonstrate suboptimal performance in consistency and sensitivity, mainly attributable to the stricter threshold for defecation frequency in China. After modifications, the novel dual-symptom diagnostic framework significantly improves consistency and sensitivity, offering a more tailored approach for diagnosing constipation in Chinese population. These findings underscore the necessity for region-specific adaptations of Rome IV criteria across diverse populations.

References

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• 3. Zhu SR, Tian Y, Bai T, Hou XH. The defecation habits of people in Central China: a cross-sectional survey and a literature review. Neurogastroenterol Motil. 2020 Mar;32(S1):274. https://webofscience.clarivate.cn/wos/woscc/full-record/WOS:000521974900269