Análisis de impacto presupuestal de flavoxato, oxibutinina, tolterodina, solifenacina, darifenacina y mirabegrón para el tratamiento de incontinencia urinaria de urgencia en Colombia / Budget impact analysis of flavoxate, oxybutynin, tolterodine, solifenacin, darifenacin and mirabegron for the treatment of incontinence Urinary urgency in Colombia

INTRODUCCIÓN: El análisis de impacto presupuestal (AIP) de medicamentos anticolinérgicos para pacientes con incontinencia urinaria de urgencia en Colombia, se desarrolló en el marco del mecanismo técnico-científico para la ampliación progresiva del Plan de Beneficios en Salud con cargo a la UPC (PBSUPC) y la definición de la lista de exclusiones, establecido en el artículo 15 de la Ley 1751 de 2015. Estas tecnologías fueron seleccionadas por la Dirección de Beneficios, Costos y Tarifas del Aseguramiento en Salud del Ministerio de Salud y Protección Social (MinSalud), y remitidas al Instituto de Evaluación Tecnológica en Salud (IETS) para su evaluación. La incontinencia urinaria o perdida involuntaria de orina es causada por la pérdida del control de la vejiga (1). Este problema de alta ocurrencia en la población general no cuenta con una prevalencia bien establecida (2,3), se estima que cerca de la mitad de los pacientes con problemas de vejiga nunca consultan esta condición con su médico tratante, aspecto por el cual no es tratada ni registrada. Por otra parte, si se conoce que el mayor número de casos de incontinencia urinaria se presentan en la población adulta y en mayor proporción en el sexo femenino durante el embarazo, el parto o la menopausia; llegando a considerarse el doble de frecuencia en sexo femenino frente al masculino. La incontinencia urinaria suele clasificarse en cuatro tipos de acuerdo a la posible causal asociada a esta condición: Incontinencia de esfuerzo, como aquella donde la vejiga no puede controlar el aumento de presión ante el ejercicio, la tos o los estornudos; este tipo de incontinencia es más frecuente en hombres que han tenido cirugía de próstata. Incontinencia de urgencia, es causada por la contracción súbita e involuntaria de la vejiga. Incontinencia mixta, es aquella donde se combina la incontinencia de esfuerzo y de urgencia, este tipo de incontinencia es más frecuente en las mujeres en edad adulta. Incontinencia funcional, como aquella incapacidad para retener la orina por razones distintas neuropáticas asociadas a otra condición de salud. Así mismo, el tratamiento de esta condición depende principalmente del tipo de incontinencia urinaria, la causa de la misma y las condiciones del paciente. Dentro de las alternativas de tratamiento se listan: la rehabilitación del músculo pélvico, tratamiento dirigido a las mujeres jóvenes; las terapias comportamentales, a fin de asumir hábitos que favorezcan la recuperación del control de vejiga; las terapia farmacológicas y finalmente, las intervenciones quirúrgicas. En el caso de la incontinencia urinaria de urgencia y mixta, una de las alternativas usadas en la primera y segunda línea son los esquemas farmacológicos (4). El principal grupo de medicamentos son los agentes antiespasmódicos y anticolinérgicos agrupados por la clasificación Anatómica, Terapéutica y Química (ATC por sus siglas en ingles) de la Organización Mundial de la Salud (OMS) con el código G04BD. Actualmente, este grupo de medicamentos no es parte del Plan de Beneficios en Salud con cargo a la UPC (PBSUPC). Por lo anterior, el alcance de este análisis de impacto presupuestal es determinar el esfuerzo presupuestal necesario para incorporar este grupo de medicamentos al PBSUPC, excluyendo así estos medicamentos de las Prestaciones No Incluidas en el PBSUPC. Para el desarrollo de este documento se realizó una revisión de literatura, la consulta de registros nacionales y la consulta a expertos clínicos; con el fin de identificar la prevalencia de la incontinencia urinaria de urgencia, la frecuencia y costos asociados a eventos adversos, y a la estimación de los posibles escenarios de adopción de estas tecnologías sanitarias al ser financiadas en el Plan de Beneficios en Salud con cargo a la UPC. Para determinar el precio de las tecnologías, se consultó como fuente primaria el Sistema de información de. Precios de Medicamentos (SISMED) y finalmente, los posibles impactos presupuestales para en el Sistema General de Seguridad Social en Salud (SGSSS) colombiano. TECNOLOGÍAS EVALUADAS: Tratamiento actual: Actualmente no existen alternativas farmacológicas u otro tipo de intervención dirigida al tratamiento de la incontinencia urinaria de urgencia, en el Plan de Beneficios en Salud con cargo a la Unidad de Pago por Capitación (UPC). Incorporación reglamentada por la Resolución 6408 de 2016 del Ministerio de Salud y Protección Social. De este modo, el presente AIP no incorporó costos asociados al tratamiento actual. Tecnología evaluada: Los medicamentos evaluados son los agentes antiespasmódicos y anticolinérgicos agrupados por la clasificación Anatomica, Terapéutica y Química (ATC) con el código G04BD que cuenten con registro sanitario vigente en Colombia. Este grupo incluye los principios activos: flavoxato, oxibutinina, tolterodina, solifenacina, darifenacina y mirabegrón. A continuación, se presenta una descripción de cada uno de estos principios activos incorporando dosificación para el tratamiento de incontinencia urinaria de urgencia, indicación aprobada por Instituto Nacional de Vigilancia de Medicamento (INVIMA) y algunas consideraciones especiales para su prescripción. Flavoxato: INSUMOS Y MÉTODOS: Se presenta los supuestos, parámetros y métodos utilizados para el modelo de estimación del impacto presupuestal. Perspectiva: La perspectiva usada es la del Sistema General de Seguridad Social en Salud (SGSSS), siguiendo las recomendaciones del manual para la elaboración de análisis de impacto presupuestal del IETS (9). De forma específica este análisis corresponde a las tecnologías y gastos médicos incorporados al Plan de Beneficios en Salud con cargo de la UPC. Horizonte temporal: El horizonte temporal de este AIP en el caso base corresponde a un año. Adicionalmente, se reportan las estimaciones del impacto presupuestal para los años 2 y 3, bajo el supuesto de la incorporación de los medicamentos evaluados para el Plan de Beneficios con cargo a la UPC en el año 1. Población total: Para el desarrollo del AIP se parte de la población general afiliada al SGSSS colombiano sin distinción de sexo o edad. Población objeto de análisis: Se delimita la población total a aquellos que tiene la condición de incontinencia urinaria de urgencia, incluyendo los que padecen incontinencia urinaria mixta. Para lo cual, se efectuó una búsqueda de prevalencias y proporciones en guías de práctica clínica, revisión de literatura especializada, búsqueda registros administrativos y consulta a expertos clínicos. RESULTADOS: Impacto Total e incremental: Dado que no existe tratamiento actual financiado en el Plan de Beneficios de salud con cargo a la UPC para la incontinencia urinaria de urgencia, la incorporación de los medicamentos con principios activos: flavoxato, oxibutinina, tolterodina, solifenacina, darifenacina y mirabegrón generará un esfuerzo presupuestal equivalente al costo de las nuevas tecnologias. Impacto por escenarios: En el primer escenario, se refleja la distribución actual del mercado de acuerdo con la información obtenida de SISMED para el año 2016. Esta distribución de acuerdo con la consulta de los expertos clínicos no tiene una tendencia a cambiar en las siguientes dos anualidades, debido a que no existe una diferencia significativa entre estas tecnologías que permita estimar una sustitución de tratamiento. Por otra parte, en el segundo escenario se modela una sustitución entre las alternativas terapéuticas que privilegia aquellos medicamentos que tienen una forma farmacéutica modificada para permitir una liberación prolongada del principio activo. Esta tendencia pese a ser mencionada por uno de los expertos clínicos, no es parte del consenso logrado en la etapa de consulta. Análisis de sensibilidade: Los análisis de sensibilidad estiman las variaciones del valor del impacto presupuestal incremental en el año 1 para los escenarios 1 y 2. Para cada caso se tomaron los precios mínimos, los base y los máximos, y con cada uno se calculó el valor de impacto presupuestal incremental; además, para cada uno se desarrolla un análisis de tipo determinístico y otro probabilístico.

Flavoxate in the symptomatic treatment of overactive bladder: a meta-analysis.

OBJECTIVE: Overactive bladder is a syndrome of urinary frequency and urgency, with or without urge incontinence, in the absence of local pathological factors. Since multiple causes are responsible for OAB, it requires proper diagnosis and comprehensive management. For decades, flavoxate is a globally used and accepted molecule by the urologists and the general physicians for the symptomatic treatment of OAB. In spite of its extensive use in OAB, a meta-analysis of the available publications for efficacy, safety and tolerability of flavoxate has not been conducted. This paper evaluates the strength of evidence of clinical effectiveness of safety and tolerability of flavoxate in the symptomatic treatment of OAB. METHODS: Review articles, original studies and case reports on MEDLINE, the Cochrane Library, Google Scholar, Scirus, internal repository, etc. were searched using the keyword "flavoxate". For the primary outcome, the comparative data of flavoxate versus comparator was extracted for following parameters - overall efficacy and its side effect profile. Similarly as for secondary outcome, data were extracted for flavoxate per se for overall efficacy, frequency, urinary incontinence, mixed incontinence, nocturia, unpleasant urination, stranguria and its side effect profile and were analyzed using Comprehensive Meta-Analysis (CMA) software version 2.0. RESULTS: In the current meta-analysis, 43 relevant published studies were considered which clearly demonstrated that flavoxate had improved clinical efficacy than placebo, emepronium, propantheline, and phenazopyridine. CONCLUSIONS: Amongst all the interventions studied, flavoxate was effective and well-tolerated, with almost negligible side effects, making it worthy of consideration for the treatment of OAB.

Flavoxate: present and future.

OBJECTIVE: This non-systematic review discusses the available evidence on the use of flavoxate in the treatment of overactive bladder (OAB). METHODS: Medline was searched for inclusion of relevant studies. No limitations in time were considered. RESULTS: Flavoxate hydrochloride is an antispasmodic agent which exerts an inhibition of the phosphodiesterases, a moderate calcium antagonistic activity, and a local anesthetic effect. Results from preclinical and clinical studies show that flavoxate significantly increases bladder volume capacity (BVC), with greater results if compared to other drugs such as emepronium bromide and propantheline. Moreover in clinical trials, both versus placebo or versus active comparators, flavoxate treatment was associated with a significant improvement in different low urinary tract symptoms, such as diurnal and night frequency, urgency and urinary incontinence, suprapubic pain, dysuria, hesitancy and burning. In addition flavoxate was associated with an overall more favourable safety profile than competitors. CONCLUSIONS: Several researches and a number of years of clinical practice have proven the efficacy and tolerability of flavoxate administration in the treatment of OAB and associated symptoms. However, new studies are necessary to collect more evidence on the role of this molecule in the treatment of OAB and to further explore its use in other indications such as symptomatic treatment of lower urinary tract infections.

Flavoxate in urogynecology: an old drug revisited.

INTRODUCTION AND HYPOTHESIS: Since its emergence in 1967, flavoxate has been used to treat several urogenital tract disorders irrespective of the etiology of the underlying disease, but the main indications have been overactive bladder and urge symptomatology. With the advances in anticholinergic drugs, its popularity has decreased in recent decades. METHODS: In this review we summarize the current status of flavoxate in urogynecological practice focusing on its historical background, mechanism of action, efficacy, clinical experiences, outcomes, side effects and tolerability. We reviewed and analyze all the data and draw the major conclusions. We searched MEDLINE and the Cochrane Library using the keyword "flavoxate", and summarized review articles, original studies and case reports published from 1970 to 2013. RESULTS AND CONCLUSION: We conclude that the minimal side effects and high tolerability of flavoxate make it worthy of consideration for the treatment of several clinical urogynecological conditions. It deserves more clinical studies to assess its efficacy as no randomized controlled trials have been performed with flavoxate during the last decade. More studies and novel drug formulations may reveal or improve its efficacy in daily practice.

An overview on mixed action drugs for the treatment of overactive bladder and detrusor overactivity.

OBJECTIVES: To provide an overview on the efficacy, tolerability, safety and health-related quality of life (HRQoL) of drugs with a mixed action used in the treatment of overactive bladder (OAB). EVIDENCE ACQUISITION: MEDLINE database and abstract books of the major conferences were searched for relevant publications from 1966 to 2011 and using the key words 'overactive bladder', 'detrusor overactivity', 'oxybutynin', 'propiverine', and 'flavoxate'. Two independent reviewers considered publications for inclusion and extracted relevant data, without performing a meta-analysis. EVIDENCE SYNTHESIS: Old and conflicting data do not support the use of flavoxate, while both propiverine and oxybutynin were found to be more effective than placebo in the treatment of OAB. Propiverine was at least as effective as oxybutynin but with a better tolerability profile even in the pediatric setting. Overall, no serious adverse event for any product was statistically significant compared to placebo. Improvements were seen in HRQoL with treatment by the oxybutynin transdermal delivery system and propiverine extended release. CONCLUSIONS: While there is no evidence to suggest the use of flavoxate in the treatment of OAB, both oxybutynin and propiverine appear efficacious and safe. Propiverine shows a better tolerability profile than oxybutynin. Both drugs improve HRQoL of patients affected by OAB. Profiles of each drug and dosage differ and should be considered in making treatment choices.

Anticholinergic drugs versus other medications for overactive bladder syndrome in adults.

BACKGROUND: Overactive bladder syndrome is defined as "urgency with or without urge incontinence, usually with frequency and nocturia". It is a common condition with significant economic and quality of life implications. While the condition's pathophysiology remains to be fully elucidated, pharmacotherapy is the main treatment option. Despite uncertainty as to drug treatment of choice, anticholinergics are increasingly being used in primary and secondary care settings. This review compares anticholinergic drugs with other types or classes of drugs for treating overactive bladder syndromes. OBJECTIVES: To compare anticholinergic drugs with other types or classes of drugs for treating overactive bladder symptoms. SEARCH STRATEGY: We searched the Cochrane Incontinence Group Specialised Trials Register (searched 20 December 2006) and the reference lists of relevant articles. No language or other limits were imposed. SELECTION CRITERIA: All randomised and quasi-randomised controlled trials comparing anticholinergic drugs with other drugs for the treatment of overactive bladder symptoms. At least one arm of the study used an anticholinergic drug and at least one other arm used a non-anticholinergic drug. DATA COLLECTION AND ANALYSIS: Two reviewers assessed the identified studies for eligibility and methodological quality and independently extracted data from the included studies. Data analysis was performed using RevMan software (version 4.2.8). MAIN RESULTS: Twelve trials were included in the review. There were seven crossover trials and five parallel group studies. For the comparisons between anticholinergic drugs with tricyclic antidepressants, alpha adrenergic agonists, afferent nerve inhibitors, and calcium channel blocker a single trial was identified for each. Nine trials compared flavoxate with anticholinergics. There was no evidence of a difference in cure rates between anticholinergics and flavoxate. Adverse effects were more frequent in anticholinergic groups versus flavoxate groups (RR 2.28 95% CI 1.45 to 3.56). There was no strong evidence to favour either anticholinergic drugs or the comparators. AUTHORS' CONCLUSIONS: Many of the drugs considered in trials in this review are no longer used in clinical practice (and this includes the most commonly tested - flavoxate). There is inadequate evidence as to determine whether any of the available drugs are better or worse than anticholinergic medications. Larger randomised controlled trials in clinical settings are required to further establish the role of these medications in the management of overactive bladder syndrome.

Anticholinergic drugs versus other medications for overactive bladder syndrome in adults.

BACKGROUND: Overactive bladder syndrome is defined as "urgency with or without urge incontinence, usually with frequency and nocturia". It is a common condition with significant economic and quality of life implications. While the condition's pathophysiology remains to be fully elucidated, pharmacotherapy is the main treatment option. Despite uncertainty as to drug treatment of choice, anticholinergics are increasingly being used in primary and secondary care settings. This review compares anticholinergic drugs with other types or classes of drugs for treating overactive bladder syndromes. OBJECTIVES: To compare anticholinergic drugs with other types or classes of drugs for treating overactive bladder symptoms. SEARCH STRATEGY: We searched the Cochrane Incontinence Group Specialised Trials Register (searched 20 December 2006) and the reference lists of relevant articles. No language or other limits were imposed. SELECTION CRITERIA: All randomised and quasi-randomised controlled trials comparing anticholinergic drugs with other drugs for the treatment of overactive bladder symptoms. At least one arm of the study used an anticholinergic drug and at least one other arm used a non-anticholinergic drug. DATA COLLECTION AND ANALYSIS: Two reviewers assessed the identified studies for eligibility and methodological quality and independently extracted data from the included studies. Data analysis was performed using RevMan software (version 4.2.8). MAIN RESULTS: Thirteen trials were included in the review. There were eight crossover trials and five parallel group studies. For the comparisons between anticholinergic drugs with tricyclic antidepressants, alpha adrenergic agonists, afferent nerve inhibitors, and calcium channel blocker a single trial was identified for each. Ten trials compared flavoxate with anticholinergics. There was no evidence of a difference in cure rates between anticholinergics and flavoxate. Adverse effects were more frequent in anticholinergic groups versus flavoxate groups (RR 2.28 95% CI 1.45 to 3.56). There was no strong evidence to favour either anticholinergic drugs or the comparators. AUTHORS' CONCLUSIONS: Many of the drugs considered in trials in this review are no longer used in clinical practice (and this includes the most commonly tested - flavoxate). There is inadequate no evidence as to whether any of the available is better or worse than anticholinergic medications. Larger randomised controlled trials in clinical settings are required to further establish the role of these other medications in the management of overactive bladder syndrome.

Drug-induced acute cholestatic liver damage in a patient with mutation of UGT1A1.

BACKGROUND: A 54-year-old woman presented with a 3-week history of fatigue and with jaundice that began 2 days before admission. She had been undergoing treatment with flavoxate for urinary incontinence (for 2 months before admission) and with tibolone for climacteric syndrome (for 6 months before admission). Laboratory tests revealed elevated concentrations of aminotransferases, bilirubin, gamma-glutamyltransferase and alkaline phosphatase. Liver biopsy revealed histological evidence of subacute, drug-induced liver damage. INVESTIGATIONS: Physical examination, liver function tests, serology tests, autoantibody tests, genetic analysis of the TATA box of the UGT1A1 gene, ultrasonography and CT scan; MRI cholangiography; liver biopsy. DIAGNOSIS: Drug-related hepatitis in a patient with Gilbert's syndrome. MANAGEMENT: Flavoxate and tibolone were discontinued. Liver function test results improved progressively and normalized after almost 2 months.

Urodynamic evaluation in primary enuresis: an investigative and treatment outcome correlation.

A prospective study was done in pediatric out-patient department of a tertiary care hospital to evaluate the role of urodynamics in the management of primary enuresis in the 5-14-year-old children and to compare the effectiveness of multidimensional behavioral therapy with pharmacological therapy. Hundred and nineteen children between 5-14 years with primary enuresis were evaluated clinically and investigated. Three patients with obvious organic causes were then excluded. The remaining patients were given either behavioral or pharmacological treatment on the basis of urodynamic assessment. Urodynamic abnormalities were seen in 80/116 (68.9%) patients namely uninhibited bladder contraction 50/116 (43.1%), small bladder capacity 20/116 (17.2%), large bladder capacity 4/116 (3.4%), decreased bladder compliance 3/116 (2.5%) and detrusor sphincter dyssenergia 3/116 (2.5%). Combination of abnormal micturition history stating daytime urgency or frequency or dysfunctional voiding symptoms like squatting and/or abnormal voiding charts could predict abnormal results of urodynamics correctly with sensitivity of 81% and specificity of 86.2%. Ultrasound identified only 38/80 enuretics with urodynamic abnormalities although it was 100% specific. Additionally one patient who was identified as having a small bladder capacity on voiding chart was seen to have mild pelvicalyceal dilatation on ultrasound and subsequently on urodynamic assessment was found to have Detrusor sphincter dyssenergia (DSD). Behavioral therapy as compared to drug therapy produced more complete remission (17/18 vs. 14/18) and lesser relapse rate (2/17 vs. 5/14) in monosymptomatic enuretics with normal urodynamics. In patients with urodynamic abnormality, response rates with behavioral therapy, imipramine, oxybutynin and flavoxate were 73.9% (CI 56-91.8%), 89.4% (CI 75.7-100%), 94.2% (CI 84.7-100%) and 89.4% (CI 75.7-100%), respectively. Specific drug therapy as per the urodynamic abnormality was significantly more effective 49/57 [86% (CI 77-95%)] vs 17/23 [73.9% (CI 56.1-91.9%)] at P < 0.05 than behavioral therapy in patients with underlying abnormal urodynamics. Micturition history and voiding chart can be used as screening tool for enuretics. Behavioral therapy should be the first line treatment for mono symptomatic and drug therapy for polysymptomatic enuretics. Urodynamic testing may be reserved for polysymptomatic enuretics with abnormal ultrasound or those who fail to respond to first line treatment.

Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the california medicaid program.

OBJECTIVES: To investigate persistence and adherence of medication treatment in chronic overactive bladder/urinary incontinence (OAB/UI) patients, and to evaluate OAB/UI-related comorbidity events associated with persistence. METHODS: Pharmaceutical outcomes research with a health-care provider perspective was conducted on a California Medicaid (Medi-Cal) chronic OAB/UI population. The primary end point was medication possession ratio (MPR), which was used to measure refill adherence. Secondary end points measuring persistence patterns included discontinuation of OAB drug therapy (medication-uncovered interval > 30 days) and time to discontinuation (period from the index date until the first discontinuation date). Significant factors on nonpersistence were found by using a Cox Proportional Hazards model. Factors contributing to nonadherence (MPR < 0.8) and the relationship between OAB/UI comorbidity events and persistence were examined by logistic regressions. RESULTS: Of 2496 eligible patients, 36.9% had only one OAB/UI prescription. The mean MPR was 0.34 (SD 0.21) and the median was 0.3, indicating that on average only about one-third of period of time since medication initiation was covered by the therapy. Only 122 patients exhibited > 80% adherence during the 6-month follow-up-period. Significant predictors of higher persistence included: white ethnicity, previous hospitalization length, starting with tolterodine or oxybutynin extended-release, and previous use of topical drugs or antipsychotics. Nevertheless, previous depression or urinary tract infection (UTI) diagnosis, polypharmacy, significantly increased the odds of early discontinuation. Treatment discontinuation increased the risk of UTI diagnosis by 37% in the post-treatment period (P = 0.03; OR 1.37; 95% CI 1.03-1.84), but had no significant effect on other OAB/UI-related comorbidities. CONCLUSIONS: For chronic OAB/UI patients identified in this study, both persistence and adherence with medication treatment were suboptimal. These results suggest that persistence and treatment discontinuation remains problematic for the OAB/UI population.

[Alpha-blockers and bioflavonoids in men with chronic nonbacterial prostatitis (NIH-IIIa): a prospective, placebo-controlled trial].

OBJECTIVE: The National Institutes of Health (NIH) category IIIa chronic prostatitis syndromes (non bacterial chronic prostatitis) were common disorders but with few effective therapies. Alpha-blockers and bioflavonoids had recently been reported in randomized controlled trials to improve the symptom of these disorders in a significant proportion of men. The aim of this study was to confirm these findings in a prospective randomized, placebo-controlled trial. METHODS: Forty-five men with category IIIa chronic non bacterial protatitis were randomized into three groups as follows: (1) placebo; (2) phenoxybenzamine-hydrochloride:10 mg two times a day for one month; (3) flavoxate HCI-neptumus: 200 mg three times a day for one month. The NIH chronic prostatitis symptom score was used to grade symptoms at the beginning and conclusion of the study. RESULTS: All the patients in three groups completed the study except three dropout patients in placebo group because of sever symptoms. The three groups were similar in age, duration of symptoms and initial symptom score. Patients taking placebo had a mean improvement in NIH-CPSI from 21.85 to 19.55 (not significant), while the phenoxybenzamine-hydrochloride group had a mean improvement from 21.95 to 13.75 (P < 0.01), and those taking flavoxate HCI-neptumus had a mean improvement from 21.75 to 16.95 (P < 0.05). The decrease in NIH-CPSI was associated with significant improvement in patients' clinical manifestations. CONCLUSION: Therapy with alpha-blockers was well tolerated with significant symptomatic improvement in most men having chronic non-bacterial chronic protatitis while the bioflavonoids group had no significant improvement. Mechanism of both medicines needs further study.

Tratamiento de la incontinencia urinaria en el anciano / Urinary incontinence treatment

No disponible

Using flavoxate as primary medication for patients suffering from urge symptomatology.

A drug utilization observation study collected data on a total of 1800 patients given flavoxate (Spasuret 200) over 2 weeks for urge incontinence. Efficacy and tolerance parameters were determined. A subgroup of 618 patients without urinary tract infections or benign prostatic hyperplasia were treated with flavoxate only. The subgroup (n = 618) showed a reduction of dysuria (37%), nocturia (53%), and both daytime (61%) and nighttime urge (69%). Bladder volume at first urge sensation increased by 55.1+/-58.8 ml (36%), which was comparable to data from the entire group (1800 patients). In 89.2% of all patients the residual urine volume was stable or decreased. Undesirable side effects occurred in 1.8% of cases. Both groups showed better results with flavoxate four times daily (800 mg), compared to three times daily (600 mg). Flavoxate is effective and well tolerated and causes no additional problems due to residual urine or side effects.

Estudio comparativo del flavoxate vs placebo en pacientes femeninas con urgencia e incontinencia urinaria por detrusor inestable / Comparative study of the flavoxate and placebo in feminine patients with urgency and the urinary incontinence by unstable detrusor

Para el tratamiento de la urgencia y de la incontinencia por inestabilidad del detrusor, se han utilizado innumerables medicamentos. Los más usados han sido drogas anticolinérgicas (p.e. oxibutinina, propantelina, imipramina, bloqueantes alfa androenérgicos) que desafortunadamente tienen una alta incidencia de efectos secundarios que no son tolerados por los pacientes. El flavoxate, un derivado flavónico, ha demostrado sin embargo, ejercer una actividad selectiva y directa sobre el músculo liso del tracto urinario inferior sin efectos atropínicos secundarios. En el presente estudio se comparó la eficacia y la tolerancia del Flavoxate contra Placebo en el tratamiento de pacientes con diagnóstico de incontinencia urinaria por detrusor inestable. Fueron seleccionadas 25 pacientes en la consulta externa de urología del Hospital General del Este Dr. "Domingo Luciani" de las cuales 5 recibieron el Flavoxate y 10 Placebo, evidenciándose una respuesta efectiva, segura y con muy leves efectos secundarios indeseables a dosis de 1.200 mgr v.o/día con Flavoxate, razones por lo cual lo recomendamos como tratamiento de elección en el síndrome de incontinencia y de urgencia miccional por inestabilidad del detrusor.

Flavoxate treatment of micturition disorders accompanying benign prostatic hypertrophy: a double-blind placebo-controlled multicenter investigation.

To investigate the effect of flavoxate (Urispadol) treatment on patients with symptomatic benign prostatic hypertrophy (BPH), with the main weight on the irritative symptoms, a randomized, double-blind, parallel-group, placebo-controlled and multicenter investigation was carried out. Seventy patients entered the study, 37 were allocated to flavoxate treatment on a daily dose of 1,200 mg (400 mg t.i.d.) for 12 weeks, and 33 patients were allocated to placebo treatment. In spite of a sufficient power, the study did not discriminate the two treatment groups in a statistically significant way (p > 0.05), when considering the main endpoints: the irritative symptom score and the global patient evaluation. Conservative treatment of micturition disorders accompanying BPH with flavoxate in doses of 1,200 mg/day cannot be recommended for clinical use.