Impedance Spectroscopy Method to Detect Pelvic Floor Muscle Damage—A Feasibility Study

Młyńczak, Marcel; Borycka-Kiciak, Katarzyna; Uchman-Musielak, Małgorzata; Dziki, Adam

doi:10.1007/978-981-10-9038-7_161

Cited by 5 publications

(5 citation statements)

References 10 publications

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“…The use of the specially designed ONIRY Probe resulted in an increase of measurement sensitivity compared to previous studies [45,46]. The compatibility of our results with the reference ultrasound method, when assessed using the OASI classification, was at the level of about 93% and almost 100%, for the raw and re-analyzed datasets, respectively.…”

Section: Discussionmentioning

confidence: 44%

“…Therefore, it has been used as a physical marker of tissue condition, changing along with parameters such as microscopic structure, hydration, electrolyte concentration, and others [41][42][43][44]. For these reasons, feasibility studies of impedance spectroscopy application for OASI diagnostics have been undertaken [45,46]. As a result, a system called ONIRY has been developed.…”

Section: Gradementioning

confidence: 99%

“…It only has two electrodes placed on opposite sides of the probe, allowing only for a bipolar electrode configuration. Even with this configuration, the reported method accuracy was 86.4% (with a sensitivity of 83.3% and a specificity of 94.0% between ONIRY and ultrasound) [45,46]. As the next step, the ONIRY Probe was designed, allowing for tetrapolar electrode configuration, and used together with the impedance spectroscopy device (ONIRY Meter) for estimation of resistance, reactance, impedance modules, and phase shifts.…”

Section: Gradementioning

confidence: 99%

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

et al. 2021

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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).

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Section: Discussionmentioning

confidence: 44%

Section: Gradementioning

confidence: 99%

Section: Gradementioning

confidence: 99%

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

et al. 2021

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“…So far, to the authors' knowledge, there has been no experience with utilising this technique for diagnostics of the perianal area. An investigator-initiated proof-of-concept research study with 22 patients, followed by two pilot clinical studies with prototype devices (see below) in a total of 69 post-partum women, have been completed and previously reported wherein the method validity was demonstrated [35][36][37][38] . However, it was found out that due to subtility of differences in raw impedance parameters between normal (noninjured) and injured tissue structures, clinically useful sensitivity and specificity could only be achieved by utilising nonlinear machine learning (ML) algorithms for ultimate test outcome interpretation.…”

Section: Introductionmentioning

confidence: 99%

“…However, it was found out that due to subtility of differences in raw impedance parameters between normal (noninjured) and injured tissue structures, clinically useful sensitivity and specificity could only be achieved by utilising nonlinear machine learning (ML) algorithms for ultimate test outcome interpretation. Prototypes of such device, called the ONIRY system, with the ML module gradually trained with the clinical data collected, were designed and developed [35][36] . The overall concept for this system was to serve as a rapid detection method for OASI that could be applied immediately after delivery.…”

Section: Introductionmentioning

confidence: 99%

Detection of obstetric anal sphincter injuries using machine learning-assisted impedance spectroscopy: a prospective, comparative, multicentre clinical study

Borycka,

Młyńczak,

Rosoł

et al. 2024

Preprint

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ObjectiveTo evaluate the clinical performance and safety of the ONIRY system for obstetric anal sphincter injuries (OASI) detection versus three-dimensional endoanal ultrasound (EAUS).DesignA prospective, comparative, multicentre, international study. Setting: Poland, Czechia, Slovakia, and Spain.Population152 women between the first moments up to 8 weeks after vaginal delivery.MethodsParticipants underwent EAUS and were allocated to groups based on OASIS classification: A (no perineal tear), B (1st or 2nd degree tear), or C (3rd or 4th degree, anal sphincters affected). Electric impedance was measured in the anal canal using the ONIRY system. The primary endpoint was the diagnostic outcome of impedance spectroscopy versus EAUS. Adverse events were collected. Part II involved in silico modelling and 10-time 10-fold cross-validation for automated analysis.Main Outcome MeasuresAccuracy, sensitivity, and specificity.Results30 women were allocated to group A, 61 to group B, and 61 to group C. The diagnostic outcome was determined for 147 participants. The accuracy, sensitivity, and specificity of the ML-assisted impedance spectroscopy were 87.0 ± 0.5%, 90.6 ± 2.0%, and 84.6 ± 1.9%, respectively, compared with EAUS. After data cleaning, the performance metrics of the proposed final ML model for ONIRY were: 90.0 ± 0.4%, 90.0 ± 1.2%, and 90.0 ± 0.7%, respectively. No adverse device effects or deficiencies were observed.ConclusionThe ML-assisted impedance spectroscopy appears to be a high-performance and safe method for rapid OASI detection, complementing digital rectal examination in obstetric settings.FundingThe study was financed by the Polish National Centre for Research and Development (POIR.01.01.01-00-0726/18).

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Non-invasive obstetric anal sphincter injury diagnostics using impedance spectroscopy

Borycka-Kiciak

Młyńczak

Kiciak

et al. 2019

Sci Rep

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Obstetric anal sphincter injuries are the most common cause of fecal incontinence in women yet remain under-diagnosed. The aim of this study was to assess the suitability of impedance spectroscopy for diagnosing sphincter injuries arising during delivery. This was a prospective single-center study. 22 female patients were included: 10 with symptoms of sphincter dysfunction, in the early postpartum period, and 12 unaffected, in the distant period of more than 2 years after natural delivery. The presence, extent and severity of anal sphincters injury was assessed by measuring the sphincter parameters in physical examination, the degree of sphincter damage in endoanal ultrasound imaging and the sphincters function parameters in anorectal manometry. All measurements were used as references and compared with the outcomes from the impedance spectroscopy models. Impedance spectroscopy showed the highest precision (with mean accuracy of 83.9%) in relation to transanal ultrasonography. 74.1% of its results corresponded to the results of rectal physical examination and 76.7% - to those of anorectal manometry. The method showed the highest accuracy in the assessment of the sphincter’s parameters, both anatomically and functionally. New impedance spectroscopy techniques hold promise for detecting obstetric anal sphincter injuries.

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Impedance Spectroscopy Method to Detect Pelvic Floor Muscle Damage—A Feasibility Study

Cited by 5 publications

References 10 publications

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

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

Detection of obstetric anal sphincter injuries using machine learning-assisted impedance spectroscopy: a prospective, comparative, multicentre clinical study

Non-invasive obstetric anal sphincter injury diagnostics using impedance spectroscopy

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