Costoefectividad del régimen combinado de mirabegron/solifenacina en el tratamiento del síndrome de vejiga hiperactiva en Colombia / Cost-effectiveness of the Combined Regimen of Mirabegron/Solifenacin in the Treatment of Overactive Bladder Syndrome in Colombia

Objetivo Evaluar la costoefectividad incremental del régimen combinado de mirabegron/solifenacina en comparación con el uso temprano de toxina botulínica, desde la perspectiva del sistema de salud colombiano, para el tratamiento de adultos con vejiga hiperactiva. Métodos Se empleó un modelo de Markov en que se comparan dos secuencias de tratamiento, una con y otra sin mirabegron/solifenacina, para evaluar la costoefectividad en un horizonte temporal de cinco años. Debido a la perspectiva de análisis, sólo se tuvieron en cuenta los costos médicos directos. La eficacia del tratamiento evaluado y su comparador fue medida en términos de la reducción de episodios diarios de incontinencia y de la frecuencia de micciones. Los costos fueron expresados en pesos colombianos de 2019, y se aplicó una tasa de descuento de 5% tanto para desenlaces como para costos. Resultados Para el caso base, el costo del tratamiento en la secuencia que incluye mirabegron/solifenacina fue mayor, pero generó un mayor número de años de vida ajustados por calidad, y así e obtuvo una razón de costoefectividad incremental de $13.637,184 si se considera el desenlace de reducción de episodios diarios de incontinencia de 50%, y de $29.313,848 si se considera el del 100%. Conclusiones De acuerdo con los resultados de esta evaluación, para un horizonte de análisis de cinco años, la secuencia de tratamiento con mirabegron/solifenacina es una alternativa costoefectiva, si se considera un umbral de disposición a pagar de tres veces el producto interno bruto (PIB) per cápita.

Aim To evaluate the incremental cost-effectiveness of the combined regimen of mirabegron/solifenacin compared with the early use of botulinum toxin, from the perspective of the Colombian health system, for the treatment of adults with overactive bladder. Methods A Markov model comparing two treatment sequences, one with and one without mirabegron/solifenacin, was used to assess cost-effectiveness over a five-year period. Due to the perspective of the analysis, only direct medical costs were considered. The efficacy of the evaluated treatment and its comparator was measured in terms of the reduction in the daily incontinence episodes and the frequency of micturition. The costs were expressed in Colombian pesos of 2019, and a discount rate of 5% was applied for both outcomes and costs. Results For the base case, the cost of the treatment in the sequence that includes mirabegron/solifenacin was higher, but it generated a greater number of quality-adjusted years of life, thus obtaining an incremental cost-effectiveness ratio of $13,637,184 when considering the outcome of 50% of reduction in the daily incontinence episodes, and $29,313,848 when considering 100%. Conclusions According to the results of the present assessment, for a five-year period of analysi, the mirabegron/solifenacin treatment sequence is a cost-effective alternative when considering a threshold of willingness to pay three times the per capita gross domestic product (GDP).

Long-term safety and efficacy of onabotulinumtoxinA for the prevention of chronic migraine in a South Korean population: COMPEL study

@#The international, multicenter Chronic Migraine OnabotulinumtoxinA Prolonged Efficacy Open Label (COMPEL) study evaluated long-term safety and efficacy of onabotulinumtoxinA in individuals with chronic migraine (CM). This post hoc analysis evaluates the safety and efficacy of onabotulinumtoxinA in South Korean patients for up to 108 weeks of treatment. OnabotulinumtoxinA 155 U was administered every 12 weeks for 9 treatment cycles (108 weeks). The primary efficacy measure was change from baseline in heads he-day frequency for the 28-day period ending at week 108. Additional outcome measures included change in 6-item Headache Impact Test (HIT-6) scores and measures of migrainerelated disability and quality of life. Safety and tolerability were assessed from the frequency of adverse events (AEs). Of 716 patients in the United States, South Korea, and Australia, 80 were from South Korean study sites; 58 (72.5%) South Koreans and 315 (49.5%) non-Koreans completed the study. Within-group improvements in all efficacy measures from baseline to week 108 were statistically significant (P<0.05). Mean change in headache-day frequency (SD) at week 108 was similar for South Koreans and non-Koreans (–11.8 [7.8] vs –10.6 [6.2]; P=0.115). However, at week 108, the South Korean subgroup showed significantly greater reductions in moderate to severe headache days (–10.8[7.0] vs –9.3 [5.9]; P=0.040) and in HIT-6 scores (–9.8 [8.6] vs –6.7 [7.0]; P<0.001). Treatment related AEs occurred less frequently in South Koreans than non-Koreans (7.5% vs 19.7%). In the COMPEL study, onabotulinumtoxinA was an effective and well-tolerated preventive treatment for South Koreans with CM.

A Korean Postmarketing Study Assessing the Effectiveness of OnabotulinumtoxinA for the Treatment of Neurogenic Detrusor Overactivity or Idiopathic Overactive Bladder Using a Validated Patient-Reported Outcome Measure / 대한배뇨장애요실금학회지

PURPOSE: OnabotulinumtoxinA has demonstrated efficacy and safety in the treatment of urinary incontinence (UI) associated with neurogenic detrusor overactivity (NDO) and idiopathic overactive bladder (OAB); however, real-world evidence is limited. This postmarketing surveillance study aimed to assess the effectiveness and safety of onabotulinumtoxinA in Korean patients with UI associated with NDO or OAB with an inadequate response or intolerance to anticholinergics. METHODS: Patients received 200 U (NDO) or 100 U (OAB) of onabotulinumtoxinA. Effectiveness (assessed using the validated International Consultation on Incontinence Questionnaire-Short Form [ICIQ-SF]) and safety were assessed for 1–4 months after onabotulinumtoxinA administration. RESULTS: Overall, 686 patients (NDO, 161; OAB, 525) comprised the safety population; of these, 612 patients were analyzed for effectiveness. There was a significant decrease (P5 points from baseline in the ICIQ-SF score was observed in 64.9% and 47.3% of patients in the NDO and OAB groups, respectively. Following treatment, 59.9% in the NDO group and 43.0% in the OAB group were dry. There was no effect of age on effectiveness in either group. Only 10 adverse drug reactions (ADRs) were reported in 5.6% of NDO patients and 20 ADRs in 3.2% of OAB patients. Most ADRs in both groups were related to the lower urinary tract such as dysuria (NDO, 1.2%; OAB, 0.6%) and urinary retention (NDO, 0.6%; OAB, 1.5%). CONCLUSIONS: Effectiveness and safety of onabotulinumtoxinA in Korea in a real-world setting was demonstrated.

Efficacy and Safety of OnabotulinumtoxinA in Patients With Neurogenic Detrusor Overactivity Caused by Spinal Cord Injury: A Systematic Review and Meta-analysis / 대한배뇨장애요실금학회지

PURPOSE: OnabotulinumtoxinA (BoNT-A) is a promising therapy for treating neurogenic detrusor overactivity (NDO) in individuals with spinal cord injury (SCI). This systematic review and meta-analysis aimed to carry out an in-depth review and to make an objective estimation of the efficacy and safety of BoNT-A on NDO after SCI. METHODS: The PubMed, Embase, and Cochrane databases were searched for all relevant articles published from 2001 to 2016 that referred to NDO, SCI, and BoNT-A or botulinum toxin A. All data were recorded in an Excel spreadsheet by 2 individual reviewers. Review Manager version 5.3 was used to carry out the meta-analysis. RESULTS: This analysis included 17 studies involving 1,455 patients. Compared with placebo and baseline, BoNT-A was effective in increasing maximum cystometric capacity, volume at first involuntary detrusor contraction, cystometric bladder capacity (all P < 0.00001), compliance (P=0.001), and the number of patients with complete dryness (P=0.0003), and decreasing detrusor pressure, the number of patients with no involuntary detrusor contractions, the maximum flow rate, the incidence of detrusor overactivity (all P < 0.00001), and the number of urinary incontinence episodes (P=0.001). There were no statistically significant differences between doses of 200 U and 300 U or between injections into the detrusor and submucosa. There were no life-threatening adverse events. CONCLUSIONS: BoNT-A is effective and safe in treating NDO after SCI. There were no statistically significant differences between doses of 200 U and 300 U or between injecting into the detrusor and submucosa. However, more high-quality randomized controlled trials are still needed.

Comprehensive review and update on chronic migraine

Chronic migraine (CM) is a common and disabling neurologic disorder. CM is defined as more than 15 days a month over a 3-month period, including at least 8 days per month on which their headaches and associated symptoms meet diagnostic criteria for migraine. Quality of life is highly compromised in patients with this condition, and comorbidities are more frequent than with episodic migraine. The diagnosis requires a carefully-conducted patient interview and neurologic examination, sometimes combined with additional diagnostic tests, to differentiate CM from secondary headache disorders and other primary chronic headaches. CM typically develops from episodic migraine over months to years. Several factors are associated with an increased risk of episodic migraine developing into CM, including the frequent use of abortive migraine drugs. Through identification of risk factors for progression to CM, clinicians can educate patients about modifiable risk factors and can begin appropriate individualized preventive therapy. There is a high frequency of medication overuse in CM. The first step in the management of CM complicated by medication overuse is withdrawal of the overused drugs and detoxification treatment. This article provides an overview of CM, including its epidemiology, risk factors for its development, and information on its pathophysiology, diagnosis, and management.

Use of onabotulinum toxin A in patients with idiopathic overactive bladder and a lack of efficacy, intolerance or contraindication with anticholinergics / Uso de la onabotulinumtoxina A en pacientes con vejiga hiperactiva idiopática con falta de eficacia, intolerancia o contraindicación para los anticolinérgicos

Objective To assess the efficacy and safety of onabotulinum toxin A in patients with idiopathic overactive bladder inadequately managed with anticholinergics. Materials and Methods A prospective, open-label, single centre, and interventional study was conducted, from 2008 to 2013, on consecutive patients with idiophatic overactive bladder that showed lack of efficacy or intolerance to anticholinergic agents. Results The study included 73 female patients aged 58.9 ± 12.9 years. A dose of 100 and 200 units of toxin were administered in 89 and 5 cases, respectively. Nineteen patients received a second injection, 8 patients received 3, and one patient was treated 4 times. Clinically, it was observed that 98% patients had urge urinary incontinence at baseline, as compared with 42% under treatment. Similar results were obtained regarding the number of pads used per day, from 2.8 at baseline to 0.5 after treatment as regards the urodynamic parameters, the first desire to void volume improved from 97 ± 63 mL to 139 ± 81 mL. Similar results were obtained as regards cystometric capacity and the volume of the first involuntary detrusor contraction. One patient had a positive urine culture resolved using a conventional oral antibiotic regimen. Intermittent catheterisation was required in 5 patients during the first week. Conclusions Onabotulinum toxin A injections significantly improved, not only the clinical symptoms, but also the urodynamic parameters in patients with idiopathic overactive bladder inadequately managed with anticholinergic drugs. This is a simple technique with minimal adverse effects and generally well tolerated.

Objetivo Evaluar la eficacia y seguridad de onabotulinumtoxina A en pacientes con vejiga hiperactiva idiopática con falta de eficacia, intolerancia o contraindicación para el uso de anticolinérgicos. Material and Métodos Se realizó un estudio observacional, prospectivo, abierto en un único centro entre 2008 y 2013, en pacientes consecutivos con vejiga hiperactiva idiopática con falta de eficacia o intolerancia a los anticolinérgicos. Resultados Las 73 pacientes fueron mujeres con edad de 58,9 ± 12,9 años. Se administraron 100 y 200 unidades de toxina en 89 y 5 casos, respectivamente. Diecinueve pacientes recibieron una segunda inyección, 8 pacientes 3 inyecciones y un paciente 4. Clínicamente se observó que inicialmente un 98% de las pacientes tenían incontinencia urinaria de urgencia y después del tratamiento solo un 42%; el número de absorbentes por día, pasó de 2,8 al inicio a 0,5 después del tratamiento. Respecto a los parámetros urodinámicos, el volumen del primer deseo miccional mejoró de 97 ± 63 mL a 139 ± 81 mL. Se obtuvieron resultados similares en capacidad cistométrica y el volumen de la primera contracción involuntaria del detrusor. Una paciente tuvo urocultivo positivo, resolviéndose con un régimen de antibiótico oral convencional. El cateterismo intermitente fue necesario en 5 pacientes durante la primera semana. Conclusiones Las inyecciones de onabotulinumtoxina A mejoraron significativamente no solo los síntomas clínicos, sino también los parámetros urodinámicos en pacientes con vejiga hiperactiva idiopática inadecuadamente manejados con anticolinérgicos. Esta es una técnica simple, con efectos adversos mínimos y generalmente bien tolerada.

Análise de custo-efetividade da toxina onabotulínica A no tratamento preventivo da migrânea crônica sob a perspectiva do sistema privado de saúde do Brasil / Cost-effectiveness analysis of onabotulinumtoxinA in the preventive treatment of chronic migraine under the Brazilian private health care system perspective

Objetivo: Avaliar o custo-efetividade da toxina onabotulínica A (TB) versus ausência de tratamento "não tratar" (NT) da migrânea crônica refratária a pelo menos dois medicamentos em um Sistema de Saúde Suplementar. Métodos: Modelo analítico de decisão simulou desfechos e custos em 24 semanas. Os desfechos clínicos foram: dias com cefaleia (DC); dias com cefaleia moderada/severa (DCMS); episódios de cefaleia (EC); dias com migrânea (DM) e episódios de migrânea (EM). Para o braço NT, utilizaram-se os valores basais do placebo. Para o braço TB, utilizaram-se os valores basais aplicando as reduções relacionadas ao uso do tratamento. Os custos incluídos foram custos médicos diretos. Os dados que subsidiaram as análises foram extraídos da literatura. Avaliou-se uma aplicação de TB (155U) a cada 12 semanas, totalizando duas aplicações em 24 semanas. Custos foram extraídos de bases oficiais do Brasil. Considerou-se taxa de descontinuação de 3,8% para TB na semana 24. Análises de sensibilidade probabilística (ASP) e univariada (ASU) foram realizadas para o desfecho DM. Resultados: O uso de TB proporcionou redução de 52,42% nos DC; 47,97% nos DCMS; 37,60% nos EC; 50,49% nos DM; 35,68% nos EM e uma redução de R$ 1.193 com consulta médica e hospitalização. Houve incremento de R$ 8.646 com aplicação da TB, resultando numa Razão de Custo-Efetividade Incremental (RCEI) de R$ 142,16/DC; R$ 155,35/DCMS; R$ 198,22/EC; R$ 147,61/DM e R$ 208,85/EM. A ASP e ASU comprovaram os resultados do caso base. Conclusão: Uso de TB proporciona redução dos desfechos clínicos, variando de 44% a 49%, além de redução de 54% a 60% nos custos com visitas médicas e hospitalização.

Objective: To evaluate the cost-effectiveness of onabotulinumtoxinA (OT) versus "no treatment" (NT) of chronic refractory migraine to at least two drugs in the Supplementary Brazilian Health Care System. Methods: An analytical decision model simulated outcomes and costs at 24 weeks. Clinical outcomes were: days with headache (DH); days with moderate/severe headache (DMSH); headache episodes (HE); days with migraine (DM) and episodes of migraine (EM). For the NT arm, the baseline values of placebo were used. For the OT arm, baseline values were used as reductions related to treatment use. Costs included were direct medical costs. The data that supported the analyzes were extracted from the literature. One OT application (155U) was evaluated every 12 weeks totaling 2 applications in 24 weeks. Costs were extracted from Brazilian official databases. A 3.8% discontinuation rate was considered for OT at week 24. Probabilistic (PSA) and univariate (USA) sensitivity analyzes were performed for the DM outcome. Results: The use of OT provided a reduction of 52.42% in DH; 47.97% in DMSH; 37.60% in HE; 50.49% in DM; 35.68% in EM and a reduction of R$ 1,193 with medical visits and hospitalization. There was an increase of R$ 8,646 with OT application; resulting in an incremental cost-effectiveness ratio (ICER) of R$ 142.16/DH; R$ 155.35/DMSH; R$ 198.22/HE; R$ 147.61/DM and R$ 208.85/EM. PSA and USA proved the base case results. Conclusion: Use of OT provides a reduction in clinical outcomes ranging from 44% to 49%, as well as a reduction of 54% to 60% in costs with medical visits and hospitalization.

Efficacy and Adverse Events Associated With Use of OnabotulinumtoxinA for Treatment of Neurogenic Detrusor Overactivity: A Meta-Analysis / 대한배뇨장애요실금학회지

PURPOSE: OnabotulinumtoxinA is used widely for the treatment of neurogenic detrusor overactivity. We conducted a systematic review and meta-analysis to assess its efficacy and safety for neurogenic detrusor overactivity treatment. METHODS: A systematic literature review was performed to identify all published randomized double-blind, placebo-controlled trials of onabotulinumtoxinA for neurogenic detrusor overactivity treatment. MEDLINE, Embase, and the CENTRAL were employed. Reference lists of retrieved studies were reviewed carefully. RESULTS: Six publications involving 871 patients, which compared onabotulinumtoxinA with a placebo were analyzed. Efficacy of onabotulinumtoxinA treatment was shown as a reduction of the mean number of urinary incontinence episodes per day (mean difference, -1.41; 95% confidence interval [CI], -1.70 to -1.12; P<0.00001), maximum cystometric capacity (135.48; 95% CI, 118.22–152.75; P<0.00001), and maximum detrusor pressure (-32.98; 95% CI, -37.33 to -28.62; P<0.00001). Assessment of adverse events revealed that complications due to onabotulinumtoxinA injection were localized primarily to the urinary tract. CONCLUSIONS: This meta-analysis suggests that onabotulinumtoxinA is an effective treatment for neurogenic detrusor overactivity with localized advent events.

Tratamento cosmético com OnabotulinumtoxinA (Botox®): relação entre avaliação clínica inicial, dosagem e custos / Cosmetic treatment with OnabotulinumtoxinA (Botox®): relationship between initial clinical assessment, dosage and costs

Objetivo: O objetivo deste trabalho é demonstrar como a correta avaliação clínica pode influenciar na dosagem utilizada no tratamento cosmético de onabotulinumtoxinA (Botox®, Allergan, Inc, Dublin, UK) e sua consequente relação com custo e valor do tratamento a longo prazo. Método: Foram selecionados quatro pacientes para tratamento cosmético com Toxina Botulínica tipo A. Foi realizado registro fotográfico pré-procedimento, com 15 dias pós-procedimento; 3, 4, 7 e 10 meses pós-procedimento. A avaliação inicial dos pacientes, a técnica, objetivo e as dosagens utilizadas foram comentadas pelo médico que efetuou o tratamento. A avaliação e os comentários das fotos pós-procedimentos foram realizados por outro médico especialista. Resultados: Todos os pacientes tiveram as regiões frontal, glabelar e peri-orbital tratadas. As doses totais utilizadas em cada paciente foram: paciente 1: 64U; paciente 2: 69U; paciente 3: 78U e paciente 4: 81U. Conclusões: A correta avaliação clínica é fundamental para o adequado planejamento do tratamento cosmético com Botox®. Resultados duradouros, que geram alta satisfação aos pacientes, estão associados à correta escolha das doses. O custo do tratamento cosmético de Botox® deve ser avaliado de forma global e a longo prazo.

Objective: The aim of this study is to demonstrate how the correct clinical assessment can influence the dosage used in the cosmetic treatment with onabotulinumtoxinA (Botox®, Allergan, Inc., Dublin, UK) and its consequent relationship to cost and value of long-term treatment. Method: Four patients were selected for cosmetic treatment with Botulinum Toxin Type A. Patients` pictures were taken pre procedure, 15 days post procedure, 3, 4, 7 and 10 months post procedure. The patient initial evaluation, technique, objective and dosages used were commented by the doctor who performed the treatment. Evaluation and comments of the pictures post procedure were performed by another medical specialist. Results: All patients had the frontal, glabellar, and periorbital areas treated. Total doses used for each patient were as follows: patient 1: 64U; patient 2: 69U; patient 3: 78U and patient 4: 81U. Conclusions: The correct clinical assessment is essential for proper planning of cosmetic treatment with Botox®. Long lasting results, with high satisfaction rates among patients, are associated with the correct choice of doses. The cost of Botox® cosmetic treatment should be evaluated comprehensively and in a long term manner.

Rol de onabotulinumtoxin A en el tratamiento de niños con vejiga neurogénica / The rol of Onabotulinumtoxin A in the treatment of children with a neurogenic bladder

Introducción: Onabotulinumtoxina es una alternativa terapéutica de segunda línea en pacientes sin respuesta a los anticolinérgicos. Objetivo: Evaluar los efectos de repetidas inyecciones de onabotulinumtoxina en vejigas neurogénicas refractarias al tratamiento clásico. Pacientes y métodos: Se evaluaron 82 pacientes menores de 18 años con vejiga neurogénica, en su mayoría por disrafia espinal. Todos fueron refractarios a oxibutinina oral. Si luego del tercer mes de la primer inyección en el detrusor se constataba mejoría clínica y/o urodinámica; se reinyectaban entre los 9 y 12 meses, nuevamente. De lo contrario, se indicaba cistoplastia de aumento. En algunos casos se utilizaron otros procedimientos endoscópicos - quirúrgicos accesorios. Resultados: Se reinyectaron con Onabotulinumtoxina, dos, tres, cuatro y cinco veces: 20 casos, 7, 4 y un caso, respectivamente. En el 51% promedio se logró continencia urinaria total (score cero-seco). En la primera y segunda inyección hubo incremento significativo en la media de capacidad cistométrica: de 254 a 331 ml (p: 0.007) y de 257 a 367 ml (p: 0.014); respectivamente. En algunos casos, luego de la primer inyección mejoró significativamente la compliance: de 6,9 a 11,4 ml/cmH2O (p: 0.05). La media de presión del detrusor al final del llenado disminuyó en promedio de 37 a 34,4 cmH2O. La sobreactividad del detrusor (n:22) se atenuó en el 54,4% luego de la primer inyección. No se registraron efectos adversos mayores con las reinyecciones. En 15 pacientes refractarios a OnabotulinumtoxinA se realizó ampliación vesical. Conclusión: Luego del tratamiento con onabotulinumtoxina, la continencia urinaria alcanzada fue del 50% promedio. La capacidad cistometrica se incrementó significativamente con las dos primeras inyecciones; aunque no se acompañó paralelamente de un importante descenso de presiones endovesicales. El uso de onabotulinumtoxina ha logrado suprimir o retrasar la clásica indicación de cistoplastia de aumento en niños refractarios a los anticolinérgicos (AU)

Introduction: OnabotulinumtoxinA is a second-line alternative therapy for patients who do not respond to anticholinergics. Aim: To evaluate the impact of repeated injections of OnabotulinumtoxinA in neurogenic bladders refractory to conventional treatment. Patients and methods: 82 patients younger than 18 years with a neurogenic bladder, in the majority due to spinal dysraphism, were evaluated. All were refractory to oral oxybutynin. If in the third month after the first injection in the detrusor clinical and/or urodynamic improvement was observed, between 9 and 12 months later a second injection was given. If not, augmentation cystoplasty was indicated. In some cases other endoscopic/surgical procedures were used. Results: Twenty, seven, four, and one case were reinjected with OnabotulinumtoxinA, two, three, four, and five times, respectively. In a mean of 51% of the patients total urinary continence was achieved (score zero - completely dry). On the first and second injection a significant increase of the maximum cystometric capacity was observed: from 254 to 331 ml (p: 0.007) and from 257 to 367 ml (p: 0.014), respectively. In some cases, after the first injection compliance improved significantly: from 6.9 to 11.4 ml/cmH2O (p: 0.05). Mean end filling detrusor pressure diminished from 37 to 34.4 cmH2O. Detrusor overactivity (n: 22) attenuated in 54.4% after the first injection. No major adverse effects were recorded after the reinjections. In 15 patients that were refractory to OnabotulinumtoxinA augmentation cystoplasty was performed. Conclusion: After OnabotulinumtoxinA treatment, 50% urinary continence was achieved. Cystometric capacity increased significantly after the first two injections; however, it was not associated with an important decrease of intravesical pressure. The use of OnabotulinumtoxinA may avoid or delay the classical indication of augmentation cystoplasty in anticholinergicrefractory children (AU)

Intravesical OnabotulinumtoxinA Injection for Overactive Orthotopic Ileal Neobladder: Feasibility and Efficacy / 대한배뇨장애요실금학회지

The efficacy of intravesical onabotulinumtoxinA (BTXA) in the treatment of overactive bladder (OAB) has been well documented. The use of BTXA injection in orthotopic neobladders is yet to be studied. We present 4 cases of patients injected with intravesical BTXA for overactive orthotopic ileal neobladder. We recorded patient demographics, presenting and follow-up symptoms, urodynamic profiles, and Patient Global Impression of Improvement (PGI-I) scores. The 4 patients reported varying degrees of subjective improvements in the symptoms, including urgency, urge incontinence, and pad usage. Mean follow-up duration was 8.3 months (range, 5-14 months). Average PGI-I score was 3 ("a little better") (range, 2-4). To our knowledge, the current study is the first case series examining BTXA injection for orthotopic neobladder overactivity. BTXA injection yielded varying degrees of objective and subjective improvements, without significant complications. Intravesical BTXA injection is feasible and may be considered as a potential treatment alternative for OAB in orthotopic neobladders, although further study is warranted.

OnabotulinumtoxinA for neurogenic detrusor overactivity and dose differences: a systematic review

Purpose To evaluate the efficacy and safety of onabotulinumtoxinA for patients with neurogenic detrusor overactivity (NDO). Materials and Methods We searched the Cochrane Library, PUBMED, EMBASE, Chinese Bio-medicine database, China Journal Full-text Database, VIP database, Wanfang database for randomized controlled trials (from inception to September 2012). Two authors independently selected studies, extracted data and assessed the methodological and evidence quality using the Cochrane Risk of Bias Table and GRADE (Grading of Recommendations, Assessment, Development and Evaluation) respectively. Data analysis was performed by RevMan 5.1 and descriptive analysis was employed if necessary. Results Eight studies were selected (n=1879 participants). OnabotulinumtoxinA was more related to urinary tract infection (UTI) (200U: OR 1.72, CI: 1.18-2.52; 300U: OR 1.88, CI: 1.31-2.69) versus placebo. Also, OnabotulinumtoxinA was superior to placebo in improving maximum cystometric capacity (MCC) (200U: OR 138.80, CI: 112.45-165.15; 300U: OR 152.09, CI: 125.25-178.93) and decreasing maximum detrusor pressure (MDP) (200U: MD -29.61, CI: -36.52--22.69; 300U: MD-28.92, CI: -39.59--18.25). However, there were no statistical differences between 200U and 300U onabotulinumtoxinA in UTI (OR 0.84, CI: 0.58-1.22), MCC (OR-12.72, CI: -43.36-17.92) and MDP (MD 2.21, CI: -6.80-11.22). Conclusions OnabotulinumtoxinA may provide superior clinical and urodynamic benefit for populations with NDO. High-quality studies are required for evaluating the optimal dose, long-term application and when to perform repeated injections. .

Comparação da eficácia entre a toxina onabotulínica A com a abobotulínica A, na equivalência de 1: 3, para o tratamento da assimetria na paralisia facial de longa duração / Comparison of the efficacy of the 1:3 onabotulinumtoxinA:abobotulinumtoxinA ratio for the treatment of asymmetry after long-term facial paralysis

A aplicação de toxina botulínica A no lado não paralisado (LNP) é feita para tratar a assimetria resultante da paralisia facial (PF). As unidades de toxina onabotulinica A (Ona) e toxina abobotulinica A (Abo) não são equivalentes. Comparou-se a taxa de conversão de 1:3 em pacientes com PF. Cinquenta e cinco pacientes (idade entre 16 e 67 anos, 43 mulheres), com PF de longa duração foram tratados de forma aleatória com a aplicação de Ona (n = 25) ou Abo (n = 30) no LNP. Efeitos adversos, simetria facial, satisfação subjetiva e Índice de Incapacidade Facial (IIF) foram avaliados após 1 e 6 meses. Os resultados mostraram que a incidência de efeitos adversos foi maior com Abo (93,3% vs. 64,0%, p = 0,007). Avaliação Clínica do LNP diminuiu após 1 mês e aumentou novamente aos 6 meses, sem diferenças entre os grupos. A nota do lado paralisado (LP) foi menor no grupo Ona antes do tratamento, mas semelhante em ambos os grupos depois do tratamento. A nota do LP aumentou depois de 1 mês, e aos 6 meses foi ainda maior que a nota de prétratamento em ambos os grupos. A avaliação subjetiva melhorou em todos os momentos em comparação com a nota do pré-tratamento e diferiu entre os dois grupos apenas em 1 mês, quando o grupo Abo ficou um pouco mais paralisado. Índice de Função Física (IFF) e Índice de Bem-Estar Social (IBES), subescalas do Índice de Incapacidade Facial (IFF), entre os dois grupos não foram diferentes. Concluímos que ambas as toxinas reduziram a assimetria de forma eficiente em pacientes com FP. Os efeitos adversos foram maiores com Abo na equivalência de 1:3.

Botulinum toxin A injection into the nonparalyzed side (NPS) is used to treat asymmetry resulting from facial palsy (FP). OnabotulinumtoxinA (ONA) and abobotulinumtoxinA (ABO) units are not equivalent. We compared the conversion ratio of 1:3 in patients with FP. Fifty-five patients (aged 16-67 years, 43 women) with long-standing FP were randomly treated with either ONA (n = 25) or ABO (n = 30) injections into the NPS. Adverse effects, facial symmetry, subjective satisfaction, and Facial Disability Index (FDI) were assessed after 1 and 6 months. The results showed that the incidence of adverse effects was higher with ABO (93.3% vs. 64.0%, p = 0.007). Clinical scores of the NPS decreased after 1 month and increased again at 6 months, with no betweengroup differences. Scores of the paralyzed side were lower in the ONA group before treatment, but similar in both groups thereafter. The paralyzed side scores increased after 1 month, and at 6 months were still higher than the pretreatment scores in both groups. Subjective assessment improved at all time points compared to pretreatment score and differed between the two groups only at 1 month, when the ABO group was a bit too paralyzed. The Physical Function and Social/Well-Being Function subscales of the FDI did not differ between the two groups. We conclude that both toxins efficiently reduced asymmetry in patients with FP. Adverse effects were higher with ABO at an equivalence ratio of 1:3.