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Open AccessArticle

Obstetric Anal Sphincter Injury Detection Using Impedance Spectroscopy with the ONIRY Probe

1
Faculty of Mechatronics, Institute of Metrology and Biomedical Engineering, Warsaw University of Technology, 02-525 Warsaw, Poland
2
Humanitas Clinical and Research Center—IRCCS, 20089 Milan, Italy
3
Department of Biomedical Sciences, Humanitas University, 20090 Milan, Italy
4
Department of General and Colorectal Surgery, Medical University of Lodz, 90-647 Lodz, Poland
5
First Department of Gynecology and Obstetrics, Clinic for Gynecological Surgery and Oncology, Medical University of Lodz, 94-029 Lodz, Poland
6
Centre of Postgraduate Medical Education, Department of Colorectal, General and Oncological Surgery, 01-813 Warsaw, Poland
*
Author to whom correspondence should be addressed.
Appl. Sci. 2021, 11(2), 637; https://doi.org/10.3390/app11020637
Received: 24 November 2020 / Revised: 23 December 2020 / Accepted: 6 January 2021 / Published: 11 January 2021
Anal sphincter injuries occurring during natural deliveries are often a reason for severe complications, including fecal incontinence. Currently, approximately 80% of these injuries remain unrecognized. Therefore, it is crucial to focus on finding a way to diagnose such injuries as early as possible to apply the tailored treatment. This study aimed to assess the accuracy of impedance spectroscopy in the diagnostics of obstetric anal sphincter injuries (OASIs) using a specially designed rectal probe called the ONIRY Probe. The protocol of the clinical trials is described at NCT03769792. Twenty women after natural delivery were enrolled in the study and divided into two groups referring to the stage of a perineal tear (Group A: 1- or 2-degrees, and Group B: 3- or 4-degrees of a perineal tear; without or with sphincter injury, respectively). The study design included three visits during which a number of diagnostic tests were performed, including impedance spectroscopy, and 3-dimensional endoanal ultrasound, anorectal manometry, and physical examination as a reference. Statistical analysis comprised raw data analysis, as well as post-processing with the Synthetic Minority Oversampling Technique (SMOTE) method, as the output reference grade was highly imbalanced. A variety of machine learning techniques were applied for the OASI classification (≤2 vs. >2), and Wexner scale (=0 vs. >0). The best efficacies were obtained using Random Forest and k-Nearest Neighbors methods. Best accuracies were 93.3% and 99.6%, for raw and re-analyzed data, respectively, for ultrasound assessed by the OASI classification; and 79.8% and 97.0%, respectively, for clinical evaluation using the Wexner scale. Impedance spectroscopy performed using the ONIRY Probe appears to be a promising diagnostic technique for anal sphincter injury detection but requires further investigation (the next phase of the pilot clinical trial is described at NCT04181840). View Full-Text
Keywords: obstetric anal sphincter injury (OASI); fecal incontinence; non-invasive diagnostics; new technology; impedance spectroscopy; ONIRY Probe obstetric anal sphincter injury (OASI); fecal incontinence; non-invasive diagnostics; new technology; impedance spectroscopy; ONIRY Probe
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MDPI and ACS Style

Młyńczak, M.; Rosoł, M.; Spinelli, A.; Dziki, A.; Wlaźlak, E.; Surkont, G.; Krzycka, M.; Pająk, P.; Dziki, Ł.; Mik, M.; Borycka-Kiciak, K. Obstetric Anal Sphincter Injury Detection Using Impedance Spectroscopy with the ONIRY Probe. Appl. Sci. 2021, 11, 637. https://doi.org/10.3390/app11020637

AMA Style

Młyńczak M, Rosoł M, Spinelli A, Dziki A, Wlaźlak E, Surkont G, Krzycka M, Pająk P, Dziki Ł, Mik M, Borycka-Kiciak K. Obstetric Anal Sphincter Injury Detection Using Impedance Spectroscopy with the ONIRY Probe. Applied Sciences. 2021; 11(2):637. https://doi.org/10.3390/app11020637

Chicago/Turabian Style

Młyńczak, Marcel; Rosoł, Maciej; Spinelli, Antonino; Dziki, Adam; Wlaźlak, Edyta; Surkont, Grzegorz; Krzycka, Magda; Pająk, Paulina; Dziki, Łukasz; Mik, Michał; Borycka-Kiciak, Katarzyna. 2021. "Obstetric Anal Sphincter Injury Detection Using Impedance Spectroscopy with the ONIRY Probe" Appl. Sci. 11, no. 2: 637. https://doi.org/10.3390/app11020637

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