[Cost effectiveness of Mirabegron and antimuscarinic drugs in patients with hiperactive bladder.] / Coste-efectividad de mirabegrón y los antimuscarínicos en pacientes con vejiga hiperactiva.

OBJECTIVE: To evaluate the costeffectivenessof mirabegron in comparison to theantimuscarinic drugs tolterodine, solifenacin andfesoterodine, in the treatment of urgency, increasedmicturition frequency and urinary incontinence in patientswith overactive bladder (OAB). MATERIAL AND METHODS: A Markov model in Excel,with a time horizon of 5 years was developed fromthe National Health System and societal perspective.Clinical effectiveness was estimated from a clinical trial(SCORPIO) and a network meta-analysis. Unit costswere obtained from Spanish sources. The effectivenessof the treatments was measured as quality adjusted lifeyears(QALY). Deterministic and probabilistic sensitivityanalyses were performed. RESULTS: For the 5-year time horizon, the incrementalcost per patient with mirabegron 50 mg versustolterodine was € 195.52 and € 157.42, from theNational Health System (NHS) and societal perspectivesrespectively, with a gain of 0.0127 QALY withmirabegron. Consequently, the cost of gaining a QALYwith mirabegron versus tolterodine was 15,432 € and12,425 € respectively. The probability that mirabegronwould be cost-effective at a willingness to pay thresholdof € 30,000 was: 70% (NHS) and 71% (society)versus tolterodine; 94% (NHS and society) versussolifenacin 5 mg; 84% (NHS) and 84.5% (society)versus solifenacin 10 mg; 96% (NHS and society)versus fesoterodine 4 mg; 98% (NHS) and 99% (society)versus fesoterodine 8 mg. The highest probability thatmirabegron would be cost-effective at a willingness topay threshold of € 20.000 and € 25.000 per QALYgained, is obtained versus fesoterodine 4 mg and 8 mgfrom both NHS and society perspectives. CONCLUSIONS: The treatment of patients with OABwith mirabegron 50 mg is likely to be cost-effectivecompared to treatment with antimuscarinics.

OBJETIVO: Evaluar el coste-efectividad de mirabegrón frente a los fármacos antimuscarínicos tolterodina, solifenacina y fesoterodina, en el tratamiento sintomático de la urgencia, el aumento de la frecuencia miccional y la incontinencia de urgencia en los pacientescon vejiga hiperactiva (VH).MÉTODOS: Modelo de Markov en Excel, con un horizonte temporal de 5 años, desde la perspectiva del Sistema Nacional de Salud y de la sociedad. La efectividad clínica se obtuvo de un ensayo clínico frente a tolterodina y de un metaanálisis. Los costes unitarios se obtuvieron de fuentes españolas. La efectividad de los tratamientos se midió como años de vida ajustados por calidad de vida (AVAC). Se realizaron análisis de sensibilidad determinísticos y probabilísticos. RESULTADOS: Para el horizonte temporal de 5 años, el coste incremental por paciente con mirabegrón 50 mg frente a tolterodina es de 195,52 € y 157,42 €, desde las perspectivas del Sistema Nacional de Salud (SNS) y social, respectivamente, con una ganancia de 0,0127 AVAC con mirabegrón. El coste de ganar un AVAC con mirabegrón frente a tolterodina sería de 15.432 € y de 12.425 €, respectivamente. La probabilidad de que mirabegrón sea coste-efectivo frente a tolterodina, sería del 70% y del 71%, respectivamente. Para el SNS, la probabilidad de coste-efectividad de mirabegrón frente a solifenacina 5 y 10 mg sería del 84% y del 84,5%, respectivamente y en comparación con fesoterodina 4 y 8 mg sería del 96% y 98%, respectivamente. CONCLUSIONES: El tratamiento de los pacientes con VH con mirabegrón 50 mg es probablemente coste- efectivo en comparación con el tratamiento con antimuscarínicos.

Coste-efectividad de mirabegrón y los antimuscarínicos en pacientes con vejiga hiperactiva / Cost effectiveness of Mirabegron and antimuscarinic drugs in patients with hiperactive bladder

OBJETIVO: Evaluar el coste-efectividad de mirabegrón frente a los fármacos antimuscarínicos tolterodina, solifenacina y fesoterodina, en el tratamiento sintomático de la urgencia, el aumento de la frecuencia miccional y la incontinencia de urgencia en los pacientes con vejiga hiperactiva (VH). MÉTODOS: Modelo de Markov en Excel, con un horizonte temporal de 5 años, desde la perspectiva del Sistema Nacional de Salud y de la sociedad. La efectividad clínica se obtuvo de un ensayo clínico frente a tolterodina y de un metaanálisis. Los costes unitarios se obtuvieron de fuentes españolas. La efectividad de los tratamientos se midió como años de vida ajustados por calidad de vida (AVAC). Se realizaron análisis de sensibilidad determinísticos y probabilísticos. RESULTADOS: Para el horizonte temporal de 5 años, el coste incremental por paciente con mirabegrón 50 mg frente a tolterodina es de 195,52 Euros y 157,42 Euros, desde las perspectivas del Sistema Nacional de Salud (SNS) y social, respectivamente, con una ganancia de 0,0127 AVAC con mirabegrón. El coste de ganar un AVAC con mirabegrón frente a tolterodina sería de 15.432 Euros y de 12.425 Euros, respectivamente. La probabilidad de que mirabegrón sea coste-efectivo frente a tolterodina, sería del 70% y del 71%, respectivamente. Para el SNS, la probabilidad de coste-efectividad de mirabegrón frente a solifenacina 5 y 10 mg sería del 84% y del 84,5%, respectivamente y en comparación con fesoterodina 4 y 8 mg sería del 96% y 98%, respectivamente. conclusiones: El tratamiento de los pacientes con VH con mirabegrón 50 mg es probablemente coste- efectivo en comparación con el tratamiento con antimuscarínicos

OBJECTIVE: To evaluate the costeffectiveness of mirabegron in comparison to the antimuscarinic drugs tolterodine, solifenacin and fesoterodine, in the treatment of urgency, increased micturition frequency and urinary incontinence in patients with overactive bladder (OAB). MATERIAL AND METHODS: A Markov model in Excel, with a time horizon of 5 years was developed from the National Health System and societal perspective. Clinical effectiveness was estimated from a clinical trial (SCORPIO) and a network meta-analysis. Unit costs were obtained from Spanish sources. The effectiveness of the treatments was measured as quality adjusted lifeyears (QALY). Deterministic and probabilistic sensitivity analyses were performed. RESULTS: For the 5-year time horizon, the incremental cost per patient with mirabegron 50 mg versus tolterodine was Euros 195.52 and Euros 157.42, from the National Health System (NHS) and societal perspectives respectively, with a gain of 0.0127 QALY with mirabegron. Consequently, the cost of gaining a QALY with mirabegron versus tolterodine was 15,432 Euros and 12,425 Euros respectively. The probability that mirabegron would be cost-effective at a willingness to pay threshold of Euros 30,000 was: 70% (NHS) and 71% (society) versus tolterodine; 94% (NHS and society) versus solifenacin 5 mg; 84% (NHS) and 84.5% (society) versus solifenacin 10 mg; 96% (NHS and society) versus fesoterodine 4 mg; 98% (NHS) and 99% (society) versus fesoterodine 8 mg. The highest probability that mirabegron would be cost-effective at a willingness to pay threshold of Euros 20.000 and Euros 25.000 per QALY gained, is obtained versus fesoterodine 4 mg and 8 mg from both NHS and society perspectives. CONCLUSIONS: The treatment of patients with OAB with mirabegron 50 mg is likely to be cost-effective compared to treatment with antimuscarinics

Prospective long-term results, complications and risk factors in pelvic organ prolapse treatment with vaginal mesh.

OBJECTIVE: To assess the long-term results and complications of pelvic organ prolapse treatment with transvaginal mesh. STUDY DESIGN: Prospective observational study of 75 women who underwent surgery between 2005 and 2008 by the same surgeon. 44 patients (58,7%) underwent concomitant treatment of stress urinary incontinence. Anatomical criterion for failure was prolapse grade >I in any compartment. Analysis of functional features consisted of an assessment of urinary, sexual, and defecation symptoms, and pelvic pain. Subjective global evaluation of the treatment was carried out through the Visual Analogue Scale (VAS). Analysis of the early and late complications and their medical or surgical management was performed. Evaluation of risk factors for failure of treatment and extrusion was carried out through logistic regression. RESULTS: The median follow-up was 5,3 years. The anatomical results showed correction in 91,3% of the patients. Median subjective VAS evaluation: 9/10. Urinary symptoms improved after the surgery. Constipation and dyspareunia rates worsened. Pelvic pain improved. There were two early complications: one rectal perforation, repaired intraoperatively and one pulmonary embolism, managed medically. Late complications: 9 extrusions (3 managed with topical oestrogen, 3 with expectant management, and 3 reoperated, one twice), one cervix elongation and one forgotten gauze (both reoperated), 4 de novo pain managed successfully conservatively. 58,8% of the complications occurred after one year. Risk factors analyzed showed no statistical significance. CONCLUSIONS: Vaginal mesh provides favorable anatomical, functional and subjective outcomes in long-term follow-up. The number of complications is relatively low, but many complications occurred a long-time after surgery.

The 3-day bladder diary is a feasible, reliable and valid tool to evaluate the lower urinary tract symptoms in women.

AIMS: To evaluate the feasibility (% of completion), reliability (test-retest and inter-observer) and validity (convergent vs. questionnaires and vs. urodynamic study-UDS) of the 3-day bladder diary (3dBD) in women with lower urinary tract symptoms (LUTS). METHODS: Epidemiological, descriptive, cross-sectional and prospective study. Fourteen Functional Urology and Urodynamic Units participated. One hundred thirty-six women with mean age (SD) 55.2 (13.8) years with LUTS, without bladder catheterization and who were able to fill in the 3dBD were included. An UDS was performed. They filled in the 3dBD in two times separated by 15 days (test and retest), the International Consultation on Incontinence-Short Form (ICIQ-UI SF) and the Bladder Control Self-Assessment Questionnaire (BSAQ). RESULTS: One hundred ten women completed 3dBD for test and retest. Feasibility: each 3dBD has 42 variables, 77.2% women completed 80%. Test-retest reliability: there were not differences in the proportion of patients classified as positive for each symptom (urgency: P = 0.3173; incontinence: P = 1; nocturia: P = 0.0522; frequency: P = 0.4386). The Intraclass Correlation Coefficient (ICC) ranged from 0.67 to 0.92, except for night time VVmax which was lower (0.54). Inter-observer reliability: ICC ranged from 0.64 to 0.99, except for day time VVmax (0.29) and the number of urgency episodes (0.45). VALIDITY: Spearman correlation coefficients for ICIQ-UI SF and BSAQ ranged from 0.4 to 0.6 (P < 0.0001) and for UDS were lower (P < 0.05). CONCLUSIONS: The 3dBD showed good feasibility, reliability and validity to be used in the assessment of LUTS in women.

Diagnosis and medical treatment of lower urinary tract symptoms in adult men: applying specialist guidelines in clinical practice.

UNLABELLED: What's known on the subject? and What does the study add? Several sets of comprehensive treatment guidelines (national and international) exist for managing male lower urinary tract symptoms (LUTS), but these are not widely adopted in primary and secondary care, and are not consistently applied across Europe. This paper will improve the consistency of treatment approaches for adult males with LUTS by providing a clear, concise summary of existing treatment guidelines that can be easily adopted by urologists and primary care specialists. OBJECTIVE: To review current treatment guidelines (international and national) on managing male lower urinary tract symptoms (LUTS) and to summarize them for easy application in clinical practice. METHODS: A group of European urology specialists from primary and secondary care reviewed current treatment guidelines for male LUTS. RESULTS: The most appropriate recommendations for managing male LUTS were identified from existing international and national guidelines, and were summarized and simplified for use as a quick reference guide for healthcare professionals managing LUTS in adult males. CONCLUSIONS: Current guidelines for managing male LUTS were developed by urologists and are too complex for easy application in routine practice. This brief summary of current guidance should help to achieve consistent adoption of recommendations for best practice, improve working relationships between primary care specialists and urologists and clarify which patients' treatments should be managed entirely by urology specialists.