Prospective, Randomized, Multicenter Trial of Peroneal Electrical Transcutaneous Neuromodulation vs Solifenacin in Treatment-naïve Patients With Overactive Bladder.

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.

Peroneal Electric Transcutaneous NeuroModulation (eTNM®): A Novel Method for the Treatment of the Overactive Bladder.

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.

Sleep disorders in migrants and refugees: a systematic review with implications for personalized medical approach.

BACKGROUND: Sleep disorders are very common in migrants and refugees, often as a comorbid disorder to different somatic or psychiatric diagnoses and psychological disturbances such as metabolic syndrome, post-traumatic stress disorder, depression, and anxiety disorders. OBJECTIVES: To review published prevalence rates as well as possible predictors for sleep disturbances in these vulnerable groups, including pre-migration stress, acculturation, and trauma before, during, and after migration, integration, and lifestyle in the host country with implications for predictive, preventive, and personalized medical approach (3PM). DATA SOURCES: Electronic databases PubMed, PsycInfo, and Web of Knowledge were searched using (combined) search terms "migrant," "asylum seeker," "refugee," "sleep disturbances," "sleep disorder," "insomnia," and "sleep wake disorder." STUDY ELIGIBILITY CRITERIA: Peer-reviewed studies from 2000 to 2018 reporting data on prevalence and/or predictors of any measure of sleep disturbance were included. PARTICIPANTS: Studies on international migrants and refugees, as well as internally displaced populations, were included. METHODS: We conducted a systematic review on the topic of sleep disorders in migrant and refugee populations. Only published articles and reviews in peer-reviewed journals were included. RESULTS: We analyzed five studies on sleep disorders in migrants, five studies on adult refugees, and three on refugee children and adolescents. Prevalence of sleep disorders in migrants and refugees ranges between 39 and 99%. In migrant workers, stress related to integration and adaptation to the host society is connected to higher risks of snoring, metabolic diseases, and insomnia. Sleep disturbances in refugees are predicted by past war experience. Sleep difficulties in adult and child refugees are strongly correlated to trauma. Torture of parents and grandparents can predict sleep disorders in refugee children, while being accompanied by parents to the host country has a protective effect on children's sleep. CONCLUSIONS AND IMPLICATIONS: Considering the differences in risk factors, vulnerability, and traumatic life events for different migrant populations, origins of sleep difficulties vary, depending on the migrant populations. Effects on sleep disturbances and sleep quality may be a result of integration in the host country, including changes of lifestyle, such as diet and working hours with implication for OSAS (obstructive sleep apnea) and insomnia. Compared with migrant populations, sleep disturbances in refugee populations are more correlated with mental health symptoms and disorders, especially PTSD (post-traumatic stress disorder), than with psychosocial problems. In juvenile refugee populations, psychological problems and disturbed sleep are associated with traumatic experiences during their journey to the host country. Findings highlight the need for expert recommendations for development of 3P approach stratified in the following: (1) prediction, including structured exploration of predisposing and precipitating factors that may trigger acute insomnia, screening of the according sleep disorders by validated translated questionnaires and sleep diaries, and a face-to-face or virtual setting and screening of OSAS; (2) target prevention by sleep health education for female and male refugees and migrant workers, including shift workers; and (3) personalized medical approach, including translated cognitive behavioral treatment for insomnia (CBT-I) and imagery rehearsal therapy for refugees and telehealth programs for improved CPAP adherence in migrants, with the goal to enable better sleep health quality and improved health economy.