Translation and validation into Brazilian Portuguese of the English version of the International Consultation on Incontinence Modular Questionnaire for Male Lower Urinary Tract Symptoms (ICIQ-MLUTS).

OBJECTIVES: To translate and cross-culturally adapt the English version of the International Consultation on Incontinence Modular Questionnaire for Male Lower Urinary Tract Symptoms (ICIQ-MLUTS) into Brazilian Portuguese and evaluate its psychometric properties. INTRODUCTION: Male lower urinary tract symptoms (LUTS) are frequent and commonly assessed with questionnaires. The ICIQ-MLUTS is a robust instrument that investigates the main aspects of LUTS in men and their impact on quality of life. Although highly recommended, Grade A is not as popular as the International Prostate Symptom Score (IPSS) and remained untranslated and unvalidated for Brazilian Portuguese. METHODS: After authorization by the Advisory Board of the International Consultation on Incontinence (ICIQ) the translation process was conducted according to the standard guidelines and the ICIQ validation protocol. Internal consistency was assessed using Cronbach's ⍺ coefficient and values > 0.7 were considered satisfactory. To assess test-retest reliability and reproducibility, Spearman's correlation coefficient and intraclass correlation coefficient were used. For group data, a Spearman correlation coefficient or an intraclass correlation coefficient of at least 0.70 demonstrates good test-retest reliability. A p < 0.05 was considered significant. RESULTS: One hundred and eighty-six, aged 61.41 ± 11.01 years, suffering from LUTS participated in the study between January 2021 and October 2022. Cronbach's ⍺, 0.875, demonstrated the internal consistency of the Portuguese version of ICIQ-MLUTS. The intraclass correlation coefficient of 0.912 (0.882; 0.935 - 95% CI) for the test-retest evidenced the stability and validity of the instrument. Likewise, Spearman's correlation coefficient highlighted the agreement between IPSS and ICIQ-MLUTS, 0.906, <0.001. DISCUSSION: The Portuguese version of the ICIQ-MLUTS demonstrated internal consistency, stability, and validity, in addition to agreement with the IPSS. CONCLUSION: The ICIQ-MLUTS, translated and validated into Brazilian Portuguese, is a robust and reliable instrument to assess LUTS in Brazilian men and can be used in the evaluation of treatment and research.

Tradução para o português An International Continence Society (ICS) report on the terminology for adult neurogenic lower urinary tract dysfunction (ANLUTD).

INTRODUÇÃO: A terminologia para disfunção neurogênica do trato urinário inferior em adultos (DNTUIA) deve ser definida e organizada com base clínica em um relatório de consenso. MÉTODOS: Este relatório foi criado por um Grupo de Trabalho sob o endosso e diretrizes do Standardization Steering Committee (SSC) da International Continence Society (ICS), auxiliado em intervalos por julgadores externos. Todas as definições relevantes para DNTUIA foram atualizadas com base em pesquisas nos últimos 14 anos. Um extenso processo de 18 rodadas de revisão interna e externa foi realizado para examinar exaustivamente cada definição, com tomada de decisão pela opinião coletiva (consenso). RESULTADOS: O Relatório de Terminologia para a DNTUIA, englobando 97 definições (42 novas e oito modificadas), foi desenvolvido. Este relatório é clinicamente baseado nos diagnósticos definidos mais comuns. Clareza e facilidade de uso têm sido os principais objetivos para torná-lo interpretável por profissionais e pessoas em treinamento em todos os diferentes grupos envolvidos não só na disfunção do trato urinário inferior, mas também em muitas outras especialidades médicas. CONCLUSÃO: Baseado no consenso, o Relatório de Terminologia para a DNTUIA foi produzido para auxiliar na pesquisa e na prática clínica.

Tradução para o português An International Continence Society (ICS) report on the terminology for adult neurogenic lower urinary tract dysfunction (ANLUTD)

RESUMO Introdução A terminologia para disfunção neurogênica do trato urinário inferior em adultos (DNTUIA) deve ser definida e organizada com base clínica em um relatório de consenso. Métodos Este relatório foi criado por um Grupo de Trabalho sob o endosso e diretrizes do Standardization Steering Committee (SSC) da International Continence Society (ICS), auxiliado em intervalos por julgadores externos. Todas as definições relevantes para DNTUIA foram atualizadas com base em pesquisas nos últimos 14 anos. Um extenso processo de 18 rodadas de revisão interna e externa foi realizado para examinar exaustivamente cada definição, com tomada de decisão pela opinião coletiva (consenso). Resultados O Relatório de Terminologia para a DNTUIA, englobando 97 definições (42 novas e oito modificadas), foi desenvolvido. Este relatório é clinicamente baseado nos diagnósticos definidos mais comuns. Clareza e facilidade de uso têm sido os principais objetivos para torná-lo interpretável por profissionais e pessoas em treinamento em todos os diferentes grupos envolvidos não só na disfunção do trato urinário inferior, mas também em muitas outras especialidades médicas. Conclusão Baseado no consenso, o Relatório de Terminologia para a DNTUIA foi produzido para auxiliar na pesquisa e na prática clínica.

Intradetrusor onabotulinumtoxinA injections are significantly more efficacious than oral oxybutynin for treatment of neurogenic detrusor overactivity: results of a randomized, controlled, 24-week trial.

OBJECTIVE: To prospectively compare the results of intradetrusor onabotulinumtoxinA injections and oral oxybutynin for urinary continence, urodynamic parameters and quality of life in patients with neurogenic detrusor overactivity due to spinal cord injury. METHODS: Adult patients under intermittent catheterization were randomized 1:1 to receive one injection of onabotulinumtoxinA 300U or oxybutynin 5mg, per oris, three times/day. Primary study endpoint was change in urinary incontinence episodes/24 hours and secondary study endpoints were maximum cystometric capacity, maximum detrusor pressure, bladder compliance and quality of life before randomization and at week 24. RESULTS: Sixty-eight patients participated in the trial. Significant improvements in urinary incontinence per 24 hours, all investigated urodynamic parameters and quality of life were observed in both groups. Compared with oral oxybutynin, onabotulinumtoxinA was significantly more efficacious for all parameters investigated. Non-response to treatment was higher for oral oxybutynin (23.5%) than onabotulinumtoxinA (11.8%). Dry mouth was the most common adverse in patients with oral oxybutynin (72%) and transient macroscopic hematuria in patients with onabotulinumtoxinA (28%). Only one patient with oral oxybutynin dropped out the study because of adverse effects. CONCLUSION: The comparison of the two study drugs showed that onabotulinumtoxinA was significantly more efficacious than oral oxybutynin with regard to continence, urodynamic parameters and quality of life. Clinicaltrials.gov: NCT:01477736.

Intradetrusor onabotulinumtoxinA injections are significantly more efficacious than oral oxybutynin for treatment of neurogenic detrusor overactivity: results of a randomized, controlled, 24-week trial / Injeções intradetrusoras de onabotulinumtoxinA são significativamente mais eficazes que oxibutinina oral para tratamento da hiperatividade detrusora neurogênica: resultados de estudo randomizado e controlado de 24 semanas

ABSTRACT Objective To prospectively compare the results of intradetrusor onabotulinumtoxinA injections and oral oxybutynin for urinary continence, urodynamic parameters and quality of life in patients with neurogenic detrusor overactivity due to spinal cord injury. Methods Adult patients under intermittent catheterization were randomized 1:1 to receive one injection of onabotulinumtoxinA 300U or oxybutynin 5mg, per oris, three times/day. Primary study endpoint was change in urinary incontinence episodes/24 hours and secondary study endpoints were maximum cystometric capacity, maximum detrusor pressure, bladder compliance and quality of life before randomization and at week 24. Results Sixty-eight patients participated in the trial. Significant improvements in urinary incontinence per 24 hours, all investigated urodynamic parameters and quality of life were observed in both groups. Compared with oral oxybutynin, onabotulinumtoxinA was significantly more efficacious for all parameters investigated. Non-response to treatment was higher for oral oxybutynin (23.5%) than onabotulinumtoxinA (11.8%). Dry mouth was the most common adverse in patients with oral oxybutynin (72%) and transient macroscopic hematuria in patients with onabotulinumtoxinA (28%). Only one patient with oral oxybutynin dropped out the study because of adverse effects. Conclusion The comparison of the two study drugs showed that onabotulinumtoxinA was significantly more efficacious than oral oxybutynin with regard to continence, urodynamic parameters and quality of life. Clinicaltrials.gov: NCT:01477736.

RESUMO Objetivo Comparar prospectivamente os resultados de injeções intradetrusoras de onabotulinumtoxinA e oxibutinina oral em pacientes com hiperatividade neurogênica do detrusor devido à lesão da medula espinhal, para avaliar a continência urinária, os parâmetros urodinâmicos e a qualidade de vida. Métodos Pacientes adultos em cateterismo intermitente foram randomizados 1:1 para tratamento com uma injeção de onabotulinumtoxinA 300U ou oxibutinina 5mg via oral, três vezes por dia. O desfecho primário foi alteração nos episódios de incontinência urinária em 24 horas, e os secundários foram capacidade cistométrica máxima, pressão máxima do detrusor, complacência vesical e qualidade de vida antes da randomização e na 24ª semana. Resultados Participaram do estudo 68 pacientes. Observou-se melhora significativa na incontinência urinária por 24 horas em todos os parâmetros urodinâmicos investigados e na qualidade de vida em ambos os grupos. Em comparação com a oxibutinina oral, a onabotulinumtoxinA foi significativamente mais eficaz para todos os parâmetros investigados. A falha no tratamento foi maior para oxibutinina oral (23,5%) em comparação com onabotulinumtoxinA (11,8%). A boca seca foi o evento adverso mais comum em pacientes tratados com oxibutinina oral (72%), e a hematúria macroscópica transitória naqueles tratados com onabotulinumtoxinA (28%). Apenas um paciente tratado com oxibutinina oral interrompeu o estudo por conta dos efeitos adversos. Conclusão A comparação dos dois fármacos do estudo mostrou que onabotulinumtoxinA foi significativamente mais eficaz que oxibutinina oral em relação a continência, parâmetros urodinâmicos e qualidade de vida. Clinicaltrials.gov: NCT:01477736.

Overactive bladder - 18 years - Part I.

Overactive bladder syndrome is one of the lower urinary tract dysfunctions with the highest number of scientific publications over the past two decades. This shows the growing interest in better understanding this syndrome, which gathers symptoms of urinary urgency and increased daytime and nighttime voiding frequency, with or without urinary incontinence and results in a negative impact on the quality of life of approximately one out of six individuals - including both genders and almost all age groups. The possibility of establishing the diagnosis just from clinical data made patients' access to specialized care easier. Physiotherapy resources have been incorporated into the urological daily practice. A number of more selective antimuscarinic drugs with consequent lower adverse event rates were released. Recently, a new class of oral drugs, beta-adrenergic agonists has become part of the armamentarium for Overactive Bladder. Botulinum toxin injections in the bladder and sacral neuromodulation are routine modalities of treatment for refractory cases. During the 1st Latin-American Consultation on Overactive Bladder, a comprehensive review of the literature related to the evolution of the concept, epidemiology, diagnosis, and management was conducted. This text corresponds to the first part of the review Overactive Bladder 18-years.

Overactive bladder - 18 years - Part II.

Traditionally, the treatment of overactive bladder syndrome has been based on the use of oral medications with the purpose of reestablishing the detrusor stability. The recent better understanding of the urothelial physiology fostered conceptual changes, and the oral anticholinergics - pillars of the overactive bladder pharmacotherapy - started to be not only recognized for their properties of inhibiting the detrusor contractile activity, but also their action on the bladder afference, and therefore, on the reduction of the symptoms that constitute the syndrome. Beta-adrenergic agonists, which were recently added to the list of drugs for the treatment of overactive bladder, still wait for a definitive positioning - as either a second-line therapy or an adjuvant to oral anticholinergics. Conservative treatment failure, whether due to unsatisfactory results or the presence of adverse side effects, define it as refractory overactive bladder. In this context, the intravesical injection of botulinum toxin type A emerged as an effective option for the existing gap between the primary measures and more complex procedures such as bladder augmentation. Sacral neuromodulation, described three decades ago, had its indication reinforced in this overactive bladder era. Likewise, the electric stimulation of the tibial nerve is now a minimally invasive alternative to treat those with refractory overactive bladder. The results of the systematic literature review on the oral pharmacological treatment and the treatment of refractory overactive bladder gave rise to this second part of the review article Overactive Bladder - 18 years, prepared during the 1st Latin-American Consultation on Overactive Bladder.

Overactive bladder - 18 years - Part I

ABSTRACT Abstract: Overactive bladder syndrome is one of the lower urinary tract dysfunctions with the highest number of scientific publications over the past two decades. This shows the growing interest in better understanding this syndrome, which gathers symptoms of urinary urgency and increased daytime and nighttime voiding frequency, with or without urinary incontinence and results in a negative impact on the quality of life of approximately one out of six individuals – including both genders and almost all age groups. The possibility of establishing the diagnosis just from clinical data made patients' access to specialized care easier. Physiotherapy resources have been incorporated into the urological daily practice. A number of more selective antimuscarinic drugs with consequent lower adverse event rates were released. Recently, a new class of oral drugs, beta-adrenergic agonists has become part of the armamentarium for Overactive Bladder. Botulinum toxin injections in the bladder and sacral neuromodulation are routine modalities of treatment for refractory cases. During the 1st Latin-American Consultation on Overactive Bladder, a comprehensive review of the literature related to the evolution of the concept, epidemiology, diagnosis, and management was conducted. This text corresponds to the first part of the review Overactive Bladder 18-years.

Overactive bladder - 18 years - Part II

ABSTRACT Traditionally, the treatment of overactive bladder syndrome has been based on the use of oral medications with the purpose of reestablishing the detrusor stability. The recent better understanding of the urothelial physiology fostered conceptual changes, and the oral anticholinergics – pillars of the overactive bladder pharmacotherapy – started to be not only recognized for their properties of inhibiting the detrusor contractile activity, but also their action on the bladder afference, and therefore, on the reduction of the symptoms that constitute the syndrome. Beta-adrenergic agonists, which were recently added to the list of drugs for the treatment of overactive bladder, still wait for a definitive positioning – as either a second-line therapy or an adjuvant to oral anticholinergics. Conservative treatment failure, whether due to unsatisfactory results or the presence of adverse side effects, define it as refractory overactive bladder. In this context, the intravesical injection of botulinum toxin type A emerged as an effective option for the existing gap between the primary measures and more complex procedures such as bladder augmentation. Sacral neuromodulation, described three decades ago, had its indication reinforced in this overactive bladder era. Likewise, the electric stimulation of the tibial nerve is now a minimally invasive alternative to treat those with refractory overactive bladder. The results of the systematic literature review on the oral pharmacological treatment and the treatment of refractory overactive bladder gave rise to this second part of the review article Overactive Bladder – 18 years, prepared during the 1st Latin-American Consultation on Overactive Bladder.

Botulinum toxin in neurogenic detrusor overactivity.

PURPOSE: To evaluate the effects of botulinum toxin on urodynamic parameters and quality of life in patients with neurogenic detrusor overactivity. METHODS: Thirty four adult patients with spinal cord injury and detrusor overactivity were selected. The patients received 300 units of botulinum toxin type A. The endpoints evaluated with the episodes of urinary incontinence and measured the maximum cystometric capacity, maximum amplitude of detrusor pressure and bladder compliance at the beginning and end of the study (24 weeks) and evaluated the quality of life by applying the Qualiveen questionnaire. RESULTS: A significant decrease in the episodes of urinary incontinence was observed. All urodynamic parameters presented a significant improvement. The same was observed in the quality of life index and the specific impact of urinary problems scores from the Qualiveen questionnaire. Six patients did not complete the study, two due to incomplete follow-up, and four violated protocol and were excluded from the analyses. No systemic adverse events of botulinum toxin type A were reported. CONCLUSIONS: A botulinum toxin type A showed a significantly improved response in urodynamics parameters and specific and general quality of life.

Quality of life of neurogenic patients: translation and validation of the Portuguese version of Qualiveen.

OBJECTIVE: Questionnaires for adequate assessment of the urinary function of neurological patients are not available in Portuguese. The Qualiveen, developed in France for evaluation of general and urinary-related impact on QoL, has been successfully used in neurological patients. AIM: To translate the Qualiveen, to adapt it crossculturally, and to validate it for Portuguese. METHODS: Fifty-one patients with spinal cord injury (SCI), multiple sclerosis (MS), and myelomeningocele (MMC) completed both Qualiveen and the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) twice, at an mean interval of 15.5 days. RESULTS: A reliability study revealed internal consistency (Cronbach's alpha coefficients 0.75-0.90 for all four domains). Test-retest reliability demonstrated moderate to strong stability (intraclass correlation coefficient range from 0.62 to 0.86). Construct validity was assessed using the Qualiveen's scores and ICIQ-SF final score. It was significant for the majority of Qualiveen's score domains compared with the ICIQ-SF final score. CONCLUSION: The Portuguese version of the Qualiveen was successfully adapted and validated. It can be used for evaluation of general and urinary QoL in neurological patients.