Aim To evaluate the non‐inferiority of the transcutaneous electrical stimulation technique, as compared with the percutaneous therapy (PTNS), regarding the efficacy in symptoms and QoL improvement in patients with overactive bladder (iOAB). Methods Patients with overactive detrusor (DO) and persisting symptoms after first‐line or second‐line treatment were randomized to receive either transcutaneous therapy or PTNS 1 day a week (30 min at 20 Hz and 200 cycles/s) for 12 weeks. Data from a 3‐day voiding diary and a self‐reported QoL‐questionnaire were collected pre‐treatment and at week 12. Non‐inferiority was analyzed by estimating the mean change (95% confidence interval) of daytime micturition frequency. Statistical significance level was set at P < 0.05. Results Sixty‐eight patients were included (67.6% women), mean age 59.6 years (SD 16.1). According to ITT analysis, daytime frequency decreased in both groups without statistically significant differences between them at the end of the treatment (adjusted difference 0.8; 95%CI; −0.1; 1.7); nor were differences in symptoms improvement for the variables collected through the 3‐day voiding diary. Both techniques lessened urgency incontinence episodes by more than 50% and greatly improved the QoL. There were no relevant side effects and overall adherence to the treatment was 89.7%. Conclusions This is the first RCT that evaluates the efficacy of the transcutaneous technique compared to the PTNS, and demonstrates non‐inferiority in decreasing daytime frequency. Reduction in urgency incontinence episodes and improvement of QoL were also observed. These results and ease of application of transcutaneous neuromodulation may lead to a greater prescribing of this technique.

Background The use of prothrombin complex concentrates and the role of plasma concentration of anticoagulants in the management of bleeding in patients treated with direct oral anticoagulants are still debated. Our aim was to describe management strategies and outcomes of severe bleeding events in patients treated with direct oral anticoagulants. Methods We performed a prospective cohort study of 732 patients treated with dabigatran, rivaroxaban, or apixaban hospitalized for severe bleeding, included prospectively in the registry from June 2013 to November 2015. Results Bleeding was gastrointestinal or intracranial in 37% (212 of 732) and 24% (141 of 732) of the cases, respectively. Creatinine clearance was lower than 60 ml/min in 61% (449 of 732) of the cases. The plasma concentration of direct oral anticoagulants was determined in 62% (452 of 732) of the cases and was lower than 50 ng/ml or higher than 400 ng/ml in 9.2% (41 of 452) and in 6.6% (30 of 452) of the cases, respectively. Activated or nonactivated prothrombin complex concentrates were administered in 38% of the cases (281 of 732). Mortality by day 30 was 14% (95% CI, 11 to 16). Conclusions Management of severe bleeding in patients treated with direct oral anticoagulants appears to be complex. The use of prothrombin complex concentrates differs depending on bleeding sites and direct oral anticoagulant plasma concentrations. Mortality differs according to bleeding sites and was similar to previous estimates.

Background The decision to extubate brain-injured patients with residual impaired consciousness holds a high degree of uncertainty of success. The authors developed a pragmatic clinical score predictive of extubation failure in brain-injured patients. Methods One hundred and forty brain-injured patients were prospectively included after the first spontaneous breathing trial success. Assessment of multiparametric hemodynamic, respiratory, and neurologic functions was performed just before extubation. Extubation failure was defined as the need for ventilatory support during intensive care unit stay. Extubation failure within 48 h was also analyzed. Neurologic outcomes were recorded at 6 months. Results Extubation failure occurred in 43 (31%) patients with 31 (24%) within 48 h. Predictors of extubation failure consisted of upper-airway functions (cough, gag reflex, and deglutition) and neurologic status (Coma Recovery Scale-Revised visual subscale). From the odds ratios, a four-item predictive score was developed (area under the curve, 0.85; 95% CI, 0.77 to 0.92) and internally validated by bootstrap. Cutoff was determined with sensitivity of 92%, specificity of 50%, positive predictive value of 82%, and negative predictive value of 70% for extubation failure. Failure before and beyond 48 h shared similar risk factors. Low consciousness level patients were extubated with 85% probability of success providing the presence of at least two operating airway functions. Conclusions A simplified clinical pragmatic score assessing cough, deglutition, gag reflex, and neurologic status was developed in a preliminary prospective cohort of brain-injured patients and was internally validated (bootstrapping). Extubation appears possible, providing functioning upper airways and irrespective of neurologic status. Clinical practice generalizability urgently needs external validation.

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