Daniela Marschall-Kehrel

Flexible-dose fesoterodine in elderly adults with overactive bladder: results of the randomized, double-blind, placebo-controlled study of fesoterodine in an aging population trial.

To assess the efficacy and safety of flexible‐dose fesoterodine in elderly adults with overactive bladder (OAB).

Nocturia: state of the art and critical analysis of current assessment and treatment strategies

This editorial of the topic issue of the World Journal of Urology provides a state of the art on nocturia which includes descriptions of the terminology, epidemiology, health-related quality of life, medical and financial consequences, pathophysiology, assessment tools and treatment strategies of nocturia. This summary also includes a flowchart on the pathophysiology of nocturia with illustration of the various causes of reduced bladder capacity, increased fluid intake or increased diuresis; a flowchart with the key findings of frequency–volume charts to determine the underlying pathophysiology; and a flowchart on the treatment of the various causes of nocturia. The editorial critically discusses current assessment and treatment strategies in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) and nocturia. The outcome of nocturia remains hidden in drug trials of patients with LUTS/BPH because nocturia-specific measures were not included. The authors recommend using frequency–volume charts, measurement of the hours of undisturbed sleep, and nocturia-specific quality of life questionnaires (e.g., ICIQ-N or N-Qol) in all future studies in patients with LUTS/BPH and nocturia.

Unexpected frequent hepatotoxicity of a prescription drug, flupirtine, marketed for about 30 years.

AIMS To determine efficacy of the analgesic flupirtine in the treatment of overactive bladder syndrome in a proof-of-concept study. METHODS Double-blind, double-dummy, three-armed comparison of flupirtine extended release (400 mg/day, titrated to 600 mg/day), tolterodine extended release (4 mg/day) and placebo for 12 weeks. RESULTS When major elevations of liver enzymes (more than three times the upper normal limit) were detected in several flupirtine-exposed patients, the study was prematurely discontinued. Based on study-end data, hepatotoxicity was detected in 31% of patients receiving flupirtine for ≥ 6 weeks. CONCLUSIONS Unexpected frequent and relevant toxicity can occur when testing an established drug for a new indication.

European content validation of the Self-Assessment Goal Achievement (SAGA) questionnaire in patients with overactive bladder

Introduction and hypothesisThe Self-Assessment Goal Achievement (SAGA) questionnaire is a patient-completed instrument designed to assess goal attainment in the behavioral or pharmacologic treatment of lower urinary tract symptoms (LUTS), including overactive bladder (OAB). The SAGA questionnaire allows patients to identify and rank the importance of treatment goals before treatment is initiated; the follow-up SAGA questionnaire quantifies the achievement of these patient-identified goals. The objective of this qualitative research was to confirm the content validity of the German, Spanish, Swedish, and English (UK) language versions of the SAGA questionnaire in patients with OAB with or without other LUTS.MethodsThe SAGA questionnaire was translated to each language in accordance with a well-established forward and backward harmonization method. Patient interviews were then conducted according to a cognitive debriefing methodology. Qualitative analysis of patients’ input allowed assessment of content validity of each linguistically adapted SAGA questionnaire.ResultsAll patients (n = 29; six to eight per targeted country) found the SAGA questionnaire easy to understand and to complete. Most patients completed the nine prespecified (fixed) treatment goals and were able to add up to five personal goals in the open-ended portion and rate each goal by importance. Differences were identified in how the various languages communicated some of the concepts assessed with the SAGA questionnaire. Rewording of the translated versions of the questionnaire was necessary in some cases.ConclusionsThis linguistic content validation study in four European languages indicates that SAGA is a comprehensive, easy-to-understand, and relevant questionnaire for patient-completed evaluation of LUTS/OAB symptoms and treatment goal attainment.