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
• Muscarinic Antagonists MeSH
• Urinary Bladder, Overactive * drug therapy   MeSH
• Quality of Life MeSH
• Humans MeSH
• Prospective Studies MeSH
• Solifenacin Succinate * therapeutic use   MeSH
• Treatment Outcome MeSH
• Check Tag
• Humans MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH
• Randomized Controlled Trial MeSH

CONTEXT: The choice of the most efficacious drug for patients with idiopathic overactive bladder (IOAB) remains challenging. OBJECTIVE: The aim of this network meta-analysis was to determine the most efficacious oral antimuscarinic or β-adrenoceptor agonist accounting for adverse events for the management of IOAB. EVIDENCE ACQUISITION: A comprehensive electronic search was done in MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, and Ovid for studies in any language in February 2021 considering the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement. We included all randomized controlled trials assessing oral antimuscarinics or β-adrenoceptor agonists for the treatment of IOAB. We determined the effect of specific bothersome symptoms separately. EVIDENCE SYNTHESIS: Fifty-four articles were included in our analysis. The most efficacious agents considering the evaluated outcomes were oxybutynin 15 mg/d in reducing incontinence episodes, imidafenacin 0.5 mg/d together with solifenacin 10 and 5 mg/d in reducing micturition episodes, fesoterodine 4 and 8 mg/d as well as solifenacin 10 mg/d in reducing urgency episodes, imidafenacin 0.5 mg/d and solifenacin 10 mg/d in reducing urgency urinary incontinence episodes, and solifenacin 10 mg/d, vibegron 50 mg/d, and fesoterodine 8 mg/d in improving the voided volume. Gastrointestinal problems, especially due to antimuscarinic agents, were the most prevalent adverse events. CONCLUSIONS: Taken together, there is only minimal difference between the efficacy of oral antimuscarinics and that of β-adrenoceptor agonists. Although finding the best medication for all is impossible, finding the best treatment for every individual patient can be done by considering the efficacy of a medicine for the most bothersome symptom(s) in balance with drug-specific adverse events. PATIENT SUMMARY: This study aimed to find the most efficient oral medication to treat overactive bladder, taking into consideration the adverse events. Based on our study, there is a minimal difference in the efficacy between the two major drug classes used to treat overactive bladder. Gastrointestinal problems were the most common adverse events in medical treatment of overactive bladder. Selection of the best treatment is possible through shared decision-making between the doctor and the patient based on the patient's most bothersome symptom. We provide a framework for physicians to facilitate shared decision-making with each individual patient.

• MeSH
• Receptors, Adrenergic therapeutic use   MeSH
• Muscarinic Antagonists therapeutic use   MeSH
• Benzhydryl Compounds MeSH
• Urinary Bladder, Overactive * diagnosis   drug therapy   MeSH
• Urinary Incontinence * drug therapy   MeSH
• Humans MeSH
• Network Meta-Analysis as Topic MeSH
• Solifenacin Succinate adverse effects   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Meta-Analysis MeSH
• Research Support, Non-U.S. Gov't MeSH
• Review MeSH
• Systematic Review MeSH

V článku je podán obecný přehled anticholinergik, jejich vlastnosti a možné nežádoucí účinky. Hlavním cílem je porovnání vedlejších účinků spasmolytik v léčbě syndromu OAB a odhalení možných úskalí terapie.

The article presents a general overview of anticholinergic drugs, their properties, and possible adverse effects. The main goal is to compare the side effects of spasmolytic drugs in treating overactive bladder syndrome and to identify possible pitfalls of treatment.

• Keywords
• darifenacin, fesoterodin, oxybutynin, propiverin,
• MeSH
• Muscarinic Antagonists pharmacology   adverse effects   therapeutic use   MeSH
• Cholinergic Antagonists pharmacology   adverse effects   therapeutic use   MeSH
• Urinary Bladder, Overactive * drug therapy   MeSH
• Drug Interactions MeSH
• Humans MeSH
• Drug-Related Side Effects and Adverse Reactions MeSH
• Parasympatholytics pharmacology   adverse effects   therapeutic use   MeSH
• Solifenacin Succinate therapeutic use   MeSH
• Tolterodine Tartrate therapeutic use   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Review MeSH

Cíl: Cílem práce bylo zjistit význam "warning time" při hodnocení efektivity léčby syndromu hyperaktivního močového měchýře. Materiál a metoda: V databázi PubMed byly vyhledány všechny relevantní klinické studie hodnotící warning time při medikamentózní terapii hyperaktivního močového měchýře. Výsledky: Byly nalezeny čtyři klinické studie hodnotící celkem tři preparáty pro léčbu hyperaktivního močového měchýře. Ve všech studiích bylo zjištěno prodloužení hodnoty "warning time" u studijního preparátu oproti placebu, z toho ve třech statisticky významně. Ve všech studiích byla použita jiná metodika stanovení hodnoty "warning time". Závěr: Medikamentózní léčba hyperaktivního močového měchýře vede k významnému prodloužení "warning time". K posouzení významu tohoto parametru bude nutno standardizovat metodiku stanovení a provést více prospektivních kontrolovaných klinických studií.

Aim: The aim of this study was to determine the significance of warning time for the evaluation of treatment efficacy of overactive bladder syndrome. Methods: The PubMed database was searched for all relevant clinical studies evaluating warning time for the medicamentous treatment of overactive bladder. Results: Four clinical studies evaluating three different drugs for the treatment of overactive bladder were found. The value of warning time increased in active arms compared to placebo in all studies, in three of them significantly. Various methods of evaluating warning time were used in the studies. Conclusions: Medicamentous treatment of overactive bladder leads to the significant increase of warning time. More clinical studies with a standardized method of evaluation must be performed to determine a role of warning time in the assessment of overactive bladder treatment.

• Keywords
• Warning time, Darifenacin, OXYBUTININ,
• MeSH
• Benzofurans administration & dosage   therapeutic use   MeSH
• Cholinergic Antagonists administration & dosage   therapeutic use   MeSH
• Drug Evaluation MeSH
• Urinary Bladder, Overactive * drug therapy   pathology   MeSH
• Urinary Incontinence drug therapy   pathology   MeSH
• Clinical Trials as Topic MeSH
• Humans MeSH
• Solifenacin Succinate administration & dosage   therapeutic use   MeSH
• Check Tag
• Humans MeSH
• Publication type
• Review MeSH

• MeSH
• Muscarinic Antagonists MeSH
• Drugs, Generic * economics   therapeutic use   MeSH
• Urinary Bladder, Overactive * drug therapy   MeSH
• Humans MeSH
• Solifenacin Succinate metabolism   therapeutic use   MeSH
• Syndrome MeSH
• Check Tag
• Humans MeSH

AIM: To evaluate the impact of Vesomni/Urizia/Volutsa, a fixed-dose combination tablet containing 6 mg solifenacin (antimuscarinic) and 0.4 mg tamsulosin (α-blocker), on health-related quality of life (HRQoL) and treatment satisfaction in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in routine clinical practice. METHODS: EUROPA was a noninterventional study of men with LUTS/BPH not responding to monotherapy who were prescribed Vesomni in routine clinical practice. Data were collected retrospectively (1 year) and prospectively (1 year). Assessments were performed at baseline, weeks 4 to 8, weeks 9 to 18 (optional), weeks 19 to 39 (optional), and Weeks 40 to 52. The primary endpoint was change from baseline in HRQoL, as assessed by the Overactive Bladder Questionnaire (OAB-q) symptom bother subscale score. Change from baseline in OAB-q total and coping, sleep, and social interaction subscale scores, treatment satisfaction-visual analog scale (TS-VAS), International Prostate Symptom Score (IPSS), and European Quality of Life 5-Dimension-5-Level (EQ-5D-5L) questionnaire were also evaluated. RESULTS: Five hundred and eighty-nine patients were enrolled. The mean changes in adjusted mean (95% confidence interval [CI]) OAB-q symptom bother subscale scores were -16.40 (-24.31, -8.49) at weeks 4 to 8 and -19.59 (-28.26, -10.92) at weeks 40 to 52; at weeks 40 to 52, changes were clinically meaningful in 84.6% of patients. Adjusted mean (95% CI) change from baseline to weeks 40 to 52 were 15.02 (7.35, 22.69), 19.37 (10.86, 27.89), 18.65 (7.44, 29.86), 9.85 (3.90, 15.81), and 16.09 (9.07, 23.11) for concern, coping, sleep, social interaction, and total, respectively. TS-VAS, IPSS, and EQ-5D-5L all improved, and treatment persistence at weeks 40 to 52 was 77.1%. Urinary retention was reported in four (0.7%) patients. CONCLUSIONS: Vesomni was well-tolerated and improved HRQoL and treatment satisfaction in patients with LUTS/BPH.

• MeSH
• Adult MeSH
• Drug Combinations MeSH
• Urinary Bladder, Overactive drug therapy   psychology   MeSH
• Prostatic Hyperplasia complications   MeSH
• Quality of Life MeSH
• Middle Aged MeSH
• Humans MeSH
• Prospective Studies MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Solifenacin Succinate therapeutic use   MeSH
• Patient Satisfaction MeSH
• Sulfonamides therapeutic use   MeSH
• Lower Urinary Tract Symptoms complications   drug therapy   psychology   MeSH
• Tamsulosin therapeutic use   MeSH
• Urological Agents therapeutic use   MeSH
• Treatment Outcome MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH
• Research Support, Non-U.S. Gov't MeSH
• Geographicals
• Europe MeSH

Cíl: Autoři prezentují výsledky multicentrické, neintervenční, prospektivní, jednoramenné, observační studie, jejímž cílem bylo vyhodnotit účinek solifenacinu na kvalitu života (QoL) pacientů léčených předem jiným antimuskarinikem pro hyperaktivní měchýř (OAB) a porovnat účinky solifenacinu podle předchozí léčby antimuskariniky. Materiál a metoda: V rámci studie byl hodnocen reprezentativní vzorek OAB populace (2 000 pacientů zahrnutých do 60 center v České republice, 1 481 pacientů ukončilo všech pět hodnocení a 1 892 pacientů mělo výchozí a alespoň jedno post‑léčebné hodnocení). Metodou k ověření byly dotazníky spokojenosti s léčbou: dotazník vnímání spokojenosti s léčbou (TS‑VAS), krátká forma dotazníku hyperaktivního močového měchýře (OAB‑q SF) a Evropský dotazník kvality života (EuroQoL - EQ-5D-5L). Výsledky: Zlepšení příznaků QoL a OAB bylo pozorováno po dobu 12 měsíců u populace pacientů léčených solifenacinem 5-10mg a dříve léčených jinými antimuskariniky. Vývoj celkového skóre OAB není (p = 0,45) významně ovlivněn předchozí léčbou. Skóre OAB‑q SF, včetně celkového skóre HRQoL, všech podskupin HRQoL a skóre závažnosti příznaků, se ve sledovaném období zlepšily. Změny v skóre TS‑VAS také prokázaly zlepšení celkové QoL během studovaného období. EQ-5D-5L ukázal posun směrem ke zlepšení kvality QoL pro všechny rozměry. Údaje ze třídenních deníků močového měchýře prokázaly zlepšení průběhu symptomů OAB v průběhu studie, včetně frekvence, naléhavosti, nykturie a inkontinence. Solifenacin neměl žádný významný účinek na postmikční reziduum či vyšší riziko retence moči nebo jakýkoli účinek na průtok moči. Solifenacin byl v této studii dobře tolerován. Závěr: Studie ukazuje statisticky významné zlepšení téměř všech hodnocených parametrů. Podle výsledků je solifenacin vhodným léčivem pro pacienty, kteří selhávají při léčbě jiným antimuskarinikem.

Primary Objective: The authors present the results of a multicentre, noninterventional, prospective, one-arm, observational study into the effect of solifenacin on the quality of life versus previous antimuscarinic treatment. Method: Satisfaction with treatment was measured by Perception of Treatment Satisfaction (TSVAS), Over Active Bladder-q Short Form (OAB-q SF) and EuroQol Group scoring system (EQ-5D-5L) Results: A representative sample of the OAB population was evaluated in the study (2000 patients included in 60 centers in the Czech Republic, 1481 patients completed all 5 evaluations and 1,892 patients had baseline and at least 1 post-treatment). Improvements in QoL and OAB symptoms were observed over a period of 12 months in the population of patients treated with solifenacin 5–10 mg and previously treated with other antimuscarinic agents. OAB-q SF scores, including Total HRQoL Score, all HRQoL subscores and Symptom Severity Score, all improved over the study period. Changes in TS-VAS scores also demonstrated improvements in overall QoL over the study period. The EQ-5D-5L showed shifts towards improved QoL for all dimensions. Data from 3-day bladder diaries demonstrated improvements in OAB symptoms over the course of the study, including frequency, urgency, nocturia and incontinence. Solifenacin was well tolerated in the current study with only 15 non-serious, mild adverse events reported, mainly dry mouth (n=12). Solifenacin did not have any notable effect on post-void residual volume, risk of urinary retention or any effect on urinary flow rate. Conclusion: The study shows statistical improvements in all parameters evaluated. According to the results, solifenacin is a suitable drug for patients who fail treatment with other antimuscarinics.

• MeSH
• Muscarinic Antagonists administration & dosage   pharmacology   therapeutic use   MeSH
• Adult MeSH
• Urinary Bladder, Overactive * drug therapy   MeSH
• Clinical Studies as Topic MeSH
• Middle Aged MeSH
• Humans MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Solifenacin Succinate administration & dosage   pharmacology   therapeutic use   MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Aged, 80 and over MeSH
• Aged MeSH
• Female MeSH

Akutní generalizovaná exantematózní pustulóza (AGEP) je vzácné, závažné onemocnění kůže vyznačující se rychle progredujícími nefolikulárně vázanými sterilními pustulami na erytémovém podkladu. Vzniká převážně jako reakce na nový lék do několika hodin až dnů po nasazení a hojí se zhruba do dvou týdnů po jeho vysazení. V některých případech byla vypozorována souvislost mezi mutací genu pro antagonistu interleukinu 36 (IL-36Ra), cytokinu hrajícím úlohu v protizánětlivé odpovědi, a vývojem generalizované pustulární erupce v závislosti na užití nového léku (1). Tato kazuistika pojednává o pacientovi, u kterého se onemocnění vyskytlo v souvislosti s užíváním solifenacinu. Stanovit diagnózu se nám podařilo až s určitou latencí, neboť nástup symptomů byl nestandardně pomalý, bez vyjádřených celkových příznaků. Nebyla zde ani zprvu jasná příčinná farmakologická anamnéza charakteristického vyvolávajícího léku.

Acute generalised exantematous pustulosis (AGEP) is a rare, severe skin condition characterised by acute onset of sterile pustules.It is triggered mainly by new medication and resolves approximately 2 weeks after its withdrawal. It seems to be a connectionbetween mutation of interleukin 36 antagonist receptor (IL-36Ra) and development of generalised pustular eruption after intakeof new medication in some cases (1). This case reports AGEP caused by solifenacin. It took us longer time to set the right diagnosisas in the beginning the clinical features were not quite clear and, moreover, the onset of the symptoms was slower. Also therewas no specific medication that could trigger the skin disease of AGEP.

• MeSH
• Acute Generalized Exanthematous Pustulosis * diagnosis   etiology   drug therapy   MeSH
• Glucocorticoids therapeutic use   MeSH
• Humans MeSH
• Withholding Treatment MeSH
• Aged MeSH
• Solifenacin Succinate adverse effects   MeSH
• Check Tag
• Humans MeSH
• Male MeSH
• Aged MeSH
• Publication type
• Case Reports MeSH

AIMS: To investigate the effect on urodynamics of 4 weeks treatment with solifenacin succinate in patients with neurogenic detrusor overactivity (NDO) due to multiple sclerosis (MS) or spinal cord injury (SCI). METHODS: SONIC was a prospective, multicenter, double-blind, phase 3b/4 study investigating the efficacy and safety of solifenacin 10 mg in patients with NDO due to MS or SCI. Patients (n = 189) were randomized to placebo or active treatment (solifenacin 5 mg, 10 mg or oxybutynin hydrochloride 15 mg) for 4 weeks, after a 2-week, single-blind, placebo run-in period. The primary endpoint was change in maximum cystometric capacity (MCC) from baseline to end of treatment. The primary analysis compared solifenacin 10 mg versus placebo; all other comparisons were considered secondary. Secondary endpoints included changes in urodynamic parameters, patient-reported outcomes, and safety assessments. RESULTS: In the primary analysis, solifenacin 10 mg significantly improved mean change from baseline MCC versus placebo (P < 0.001) and was associated with improvements in bladder volume at first contraction and at first leak as well as detrusor pressure at first leak. Similar results were obtained for oxybutynin versus placebo. Patient perception of bladder condition significantly improved with solifenacin 10 mg versus placebo (P = 0.041). There was a clear improvement in quality of life (QoL) in the solifenacin arms versus placebo. The overall incidence of adverse events was low. CONCLUSIONS: In patients with NDO due to MS and SCI, 4 weeks of treatment with solifenacin 10 mg improved urodynamic variables and QoL versus placebo and was well tolerated. Neurourol. Urodynam. 36:414-421, 2017. © 2015 Wiley Periodicals, Inc.

• MeSH
• Adult MeSH
• Double-Blind Method MeSH
• Urinary Bladder, Overactive drug therapy   physiopathology   MeSH
• Quality of Life MeSH
• Middle Aged MeSH
• Humans MeSH
• Young Adult MeSH
• Urinary Bladder, Neurogenic drug therapy   physiopathology   MeSH
• Aged MeSH
• Solifenacin Succinate administration & dosage   adverse effects   therapeutic use   MeSH
• Urodynamics drug effects   physiology   MeSH
• Urological Agents administration & dosage   adverse effects   therapeutic use   MeSH
• Treatment Outcome MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Young Adult MeSH
• Male MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH
• Randomized Controlled Trial MeSH

Hyperaktivní měchýř COAB] je sice benigní onemocnění, ale z pohledu obtíží pacienta a kvality života jde o velmi závažný stav. Souhrnný článek si klade za cíl informovat o novinkách z hlediska diagnostiky a léčby OAB.

• Keywords
• OXYBUTININ, trospium chlorid, Darifenacin, Mirabegron,
• MeSH
• Adrenergic beta-3 Receptor Agonists therapeutic use   MeSH
• Muscarinic Antagonists therapeutic use   MeSH
• Cholinergic Antagonists * pharmacology   classification   adverse effects   therapeutic use   MeSH
• Urinary Bladder, Overactive * diagnosis   economics   pathology   therapy   MeSH
• Quality of Life MeSH
• Humans MeSH
• Parasympatholytics pharmacokinetics   pharmacology   classification   MeSH
• Solifenacin Succinate therapeutic use   MeSH
• Tolterodine Tartrate therapeutic use   MeSH
• Urological Agents therapeutic use   MeSH
• Check Tag
• Humans MeSH