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CC BY-NC-ND 4.0 · Rev Bras Ginecol Obstet 2018; 40(04): 225-231
DOI: 10.1055/s-0038-1642631
Review Article
Thieme Revinter Publicações Ltda Rio de Janeiro, Brazil

Treatment of Non-neurogenic Overactive Bladder with OnabotulinumtoxinA: Systematic Review and Meta-analysis of Prospective, Randomized, Placebo-controlled Clinical Trials[*]

Tratamento da bexiga hiperativa não neurogênica com toxina botulínica A: revisão sistemática e metanálise de ensaios clínicos prospectivos, randomizados e placebo-controlados*
Raquel Martins Arruda
1   Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil
,
Claudia Cristina Takano
1   Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil
,
Manoel João Batista Castelo Girão
1   Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil
,
Jorge Milhem Haddad
2   Universidade de São Paulo (USP), São Paulo, SP, Brazil
,
Gabriel Francisco Aleixo
3   Universidade do Oeste Paulista, Presidente Prudente, SP, Brazil
,
Rodrigo Aquino Castro
1   Universidade Federal de São Paulo (UNIFESP), São Paulo, SP, Brazil
› Author Affiliations
Further Information

Publication History

13 February 2018

12 March 2018

Publication Date:
10 May 2018 (online)

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Abstract

We performed a systematic review and meta-analysis of randomized placebo-controlled trials that studied non-neurogenic overactive bladder patients who were treated with 100 units of onabotulinumtoxinA or placebo. The primary purpose of our study was to evaluate the clinical effectiveness with regard to urinary urgency, urinary frequency, nocturia, and incontinence episodes. Our secondary purpose consisted of evaluating the adverse effects. Our initial search yielded 532 entries. Of these, seven studies met all the inclusion criteria (prospective, randomized, placebo-controlled studies, ≥ 3 points on the Jadad scale) and were selected for analysis. For all primary endpoints, the toxin was more effective than placebo (p < 0.0001; 95% confidence interval [95CI]), namely: urgency (mean difference = -2.07; 95CI = [-2.55–1.58]), voiding frequency (mean difference = -1.64; 95CI = [-2.10–1.18]), nocturia (mean difference = -0.25; 95CI = [-0.39–0.11]) and incontinence episodes (mean difference = -2.06; 95CI= [-2.60–1.52]). The need for intermittent catheterization and the occurrence of urinary tract infection (UTI) were more frequent in patients treated with onabotulinumtoxinA than in patients treated with placebo (p < 0.0001). Compared with placebo, onabotulinumtoxinA had significantly and clinically relevant reductions in overactive bladder symptoms and is associated with higher incidence of intermittent catheterization and UTI.

Resumo

Realizou-se revisão sistemática e metanálise de estudos clínicos prospectivos, randomizados e placebo-controlados que comparavam a toxina botulínica ao placebo no tratamento da bexiga hiperativa. O objetivo primário desta metanálise foi avaliar a eficácia da toxina botulínica em relação à urgência urinária, frequência miccional, noctúria e episódios de incontinência. O objetivo secundário foi avaliar os efeitos adversos. Selecionamos estudos que incluíram somente pacientes com bexiga hiperativa não-neurogênica tratada com 100 unidades de onabotulinum toxina A ou placebo (grupo controle). Foram encontrados 532 estudos após as buscas iniciais, dos quais sete apresentaram todos os critérios de inclusão (estudos prospectivos, randomizados, placebo-controlados, ≥ 3 pontos na escala de Jadad) e fizeram parte desta análise. Para todos os objetivos primários a toxina foi mais eficaz do que o placebo, com p < 0,0001 e intervalo de confiança (IC) de 95%: urgência (diferença média = -2,07, IC = [-2,55; -1,58]), freqüência miccional (diferença média = -1,64, IC = [-2,10; -1,18]), noctúria (diferença média = -0,25, IC = [-0,39; -0,11]) e episódios de incontinência (diferença média = -2,06, IC= [-2,60; -1,52]). A necessidade de cateterização intermitente e a ocorrência de infecção urinária (ITU) foram mais frequentes no grupo toxina na comparação com o grupo placebo (p < 0,0001). A toxina botulínica promoveu melhora significativa dos sintomas de bexiga hiperativa na comparação com o placebo. Entretanto, está associada a uma maior incidência de cateterismo intermitente e infecção do trato urinário.

Keywords

overactive bladder - systematic review - botulinum toxin - randomized controlled trials

Palavras-chave

bexiga hiperativa - revisão sistemática - incontinência urinária - toxina botulínica - estudos randomizados controlados

* This revision is part of the Project Series, Guidelines and Recommendations of FEBRASGO, elaborated by the FEBRASGO National Committee Specialized in Urogynecology and Vaginal Surgery.


 

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