PURPOSE: We investigated the safety and efficacy of peroneal electrical transcutaneous neuromodulation using the URIS neuromodulation system in a home-based setting in comparison with standard treatment using solifenacin in treatment-naïve female patients with overactive bladder. MATERIALS AND METHODS: A total of 120 patients were screened, of whom 77 were randomized in a 2:1 ratio to 12 weeks of treatment with daily peroneal electrical transcutaneous neuromodulation or solifenacin 5 mg. The primary endpoint was safety; efficacy assessments included proportion of responders, defined as subjects with ≥50% reduction in bladder diary-derived variables; Overactive Bladder-Validated 8-question Screener, and European Quality of Life-5 Dimensions questionnaire; and treatment satisfaction after 12 weeks of therapy. RESULTS: Seventy-one out of 77 randomized patients completed the study. In the peroneal electrical transcutaneous neuromodulation group 6/51 (12%) patients reported a treatment-related adverse event vs 12/25 (48%) in the solifenacin group (P < .001). No clinically significant changes were observed in any other safety endpoint. The proportions of responders in the peroneal electrical transcutaneous neuromodulation group vs the solifenacin group were 87% vs 74% with respect to Patient Perception of Intensity of Urgency Scale grade 3 urgency episodes, 87% vs 75% with respect to grade 3+4 urgency episodes, and 90% vs 94% with respect to urgency incontinence episodes. In post hoc analyses we observed significant improvement over time in multiple efficacy variables in both treatment arms. CONCLUSIONS: Peroneal electrical transcutaneous neuromodulation is a safe and effective method for overactive bladder treatment associated with a significantly lower incidence of treatment-related adverse events compared to solifenacin and a considerably better benefit-risk profile.
- MeSH
- antagonisté muskarinových receptorů MeSH
- hyperaktivní močový měchýř * farmakoterapie MeSH
- kvalita života MeSH
- lidé MeSH
- prospektivní studie MeSH
- solifenacin sukcinát * terapeutické užití MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
Overactive bladder syndrome (OAB) is a prevalent medical problem with a significant impact on the quality of life of the affected individuals. Pharmacotherapy is considered the main treatment method, although it is discontinued in a significant proportion of patients due to inefficacy or associated side effects. If pharmacotherapy fails, patients can undergo peripheral neuromodulation of the somatic nerves of the lower limb or sacral neuromodulation; however, neither of these represents an ideal therapeutic tool. The Peroneal electric Transcutaneous NeuroModulation (Peroneal eTNM®), based on the selective stimulation of the peroneal nerve, is the new fully noninvasive neuromodulation method intended to treat OAB. The URIS® neuromodulation system, engineered to provide Peroneal eTNM®, consists of the URIS® device, URIS® active electrodes, and the biofeedback foot sensor (BFS). The unique design of the URIS® device and URIS® active electrodes allows for the use of a low voltage and current during neuromodulation, which significantly reduces the unpleasant sensations. The BFS allows for precise localization of the active electrodes and for continuous adjustment of the voltage and frequency to achieve the optimal therapeutic effect. The URIS® system adopts several principles of telemedicine, which makes it compatible with the US Food and Drug Administration (FDA) and European Union (EU) regulations for home-based use. This article describes both the Peroneal eTNM® method and the URIS® neuromodulation system, including its technical specifications and data from laboratory testing. Preclinical and early clinical data demonstrate the feasibility of this new method for noninvasive OAB treatment and possible implications for clinical practice.
- MeSH
- elektrody MeSH
- elektrostimulační terapie * MeSH
- hyperaktivní močový měchýř * terapie MeSH
- kvalita života MeSH
- lidé MeSH
- telemedicína * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Spojené státy americké MeSH
Background: Within the EU, some of the challenges and perceived risks now facing medical device (MD) developers result from changes in the regulatory framework, emphasizing safety. Therefore, medical technology companies must adopt stricter quality assurance measures so that individual devices can be speedily tracked and retrieved in emergency situations. Objectives: We highlight the challenges and risks faced by the European medical devices industry, particularly those faced by SMEs in the Czech Republic. We address two important research questions: Q1. Do advantages from increased regulation outweigh the additional expenses? Q2. As many MD developers are SMEs, will the new regulatory regime result in some of those companies going out of business and therefore impede future innovation? Methods: The paper focuses on a single case study, with the situation and outcomes discussed in the context of the financial results of a further 50 medical device manufacturers marketing in the Czech Republic. Results: Our findings suggest that the new legislation will result in improved safety, facilitate product recalls, but the cost and administrative burden may be high. The evidence also indicates that some SMEs may be forced to diversify to "non-medical" products, with the inevitable loss of innovative MDs being made available to patients and healthcare providers.
- MeSH
- lidé MeSH
- marketing * MeSH
- průmysl * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Česká republika MeSH
In this paper, a new approach for the periodical testing and the functionality evaluation of a fetal heart rate monitor device based on ultrasound principle is proposed. The design and realization of the device are presented, together with the description of its features and functioning tests. In the designed device, a relay element, driven by an electric signal that allows switching at two specific frequencies, is used to simulate the fetus and the mother's heartbeat. The simulator was designed to be compliant with the standard requirements for accurate assessment and measurement of medical devices. The accuracy of the simulated signals was evaluated, and it resulted to be stable and reliable. The generated frequencies show an error of about 0.5% with respect to the nominal one while the accuracy of the test equipment was within ±3% of the test signal set frequency. This value complies with the technical standard for the accuracy of fetal heart rate monitor devices. Moreover, the performed tests and measurements show the correct functionality of the developed simulator. The proposed equipment and testing respect the technical requirements for medical devices. The features of the proposed device make it simple and quick in testing a fetal heart rate monitor, thus providing an efficient way to evaluate and test the correlation capabilities of commercial apparatuses.
- MeSH
- lidé MeSH
- monitorování fyziologických funkcí MeSH
- plod * MeSH
- srdeční frekvence plodu * MeSH
- srdeční frekvence MeSH
- těhotenství MeSH
- ultrasonografie MeSH
- Check Tag
- lidé MeSH
- těhotenství MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
In this work, a MATLAB-based graphical user interface is proposed for the visual examination of several eye movements. The proposed solution is algorithm-based, which localizes the area of the eye movement, removes artifacts, and calculates the view trajectory in terms of direction and orb deviation. To compute the algorithm, a five-electrode configuration is needed. The goodness of the proposed MATLAB-based graphical user interface has been validated, at the Clinic of Child Neurology of University Hospital of Ostrava, through the EEG Wave Program, which was considered as "gold standard" test. The proposed solution can help physicians on studying cerebral diseases, or to be used for the development of human-machine interfaces useful for the improvement of the digital era that surrounds us today.
- Klíčová slova
- Matlab,
- MeSH
- dospělí MeSH
- elektrookulografie * metody MeSH
- lidé MeSH
- měření pohybů očí MeSH
- mrkání MeSH
- pohyby očí MeSH
- software MeSH
- technologie sledování pohybu očí MeSH
- uživatelské rozhraní počítače MeSH
- výzkum MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- mužské pohlaví MeSH
- Publikační typ
- kazuistiky MeSH
- práce podpořená grantem MeSH
n this work, a commercial flexible thermoelectric generator (f-TEG) was used to harvest the body thermal energy during the execution of activities of daily living (ADL). The f-TEG was placed at the level of the ankle, and the performed activities were sitting at the desk and walking. In the first stage of measurements, tests were performed to choose the value of the resistor load that maximizes the power output. Then, while performing ADL, the values of generated power were in the range from 100 to 450 μW. Moreover, while users are walking, the pattern of the output signal of f-TEG is compatible to a sine function with frequency close to that one of human gait. This preliminary result may represent a new way to study the movement of human body to recognize ADL.
