Efeitos do tratamento comportamental e do treinamento dos músculos do assoalho pélvico na síndrome da bexiga hiperativa: ensaio clínico randomizado controlado
Data
2013-11-07
Tipo
Dissertação de mestrado
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Objetivo: O presente estudo tem como objetivo avaliar e comparar os efeitos do tratamento comportamental (TC) (que inclui as técnicas de mudanças no estilo de vida, programa educacional, treinamento vesical, supressão da urgência miccional e os exercícios dos músculos do assoalho pélvico associado ao treinamento dos músculos do assoalho pélvico (TMAP), do TC isolado e do TMAP isolado nas mulheres com síndrome da bexiga hiperativa (SBH) Métodos: Foi realizado um ensaio clínico randomizado e controlado em centro único com intervenção supervisionada. Cento e dez mulheres com SBH comprovada pelo diário miccional e pelo Overactive Bladder Questionnaire V8 (OAB-V8) foram randomizadas em três grupos: TC; TMAP; ou TC+TMAP. O objetivo primário foi avaliar a taxa de cura objetiva, considerando critério composto formado por: escore OAB-V8 <8 e ausência de episódios de incontinência urinária de urgência (IUU) no diário miccional. Os desfechos secundários foram avaliar os sintomas urinários (pelo diário miccional e OAB-V8), a função muscular (pela escala NEW PERFECT), a adesão ambulatorial e domiciliar aos exercícios, e a cura subjetiva (relato de satisfação e sem desejo de novo tratamento). Os testes não-paramétricos de Kruskal-Wallis, da Razão de verossimilhança, Qui-quadrado, e de Mann-Whitney foram usados para análise estatística com p valor < 0,05 como significante. Resultados: O percentual de cura objetiva foi significativamente maior no grupo TC + TMAP em comparação com o grupo TMAP e TC isolados nas análises per protocol (p=0,006) e intention-to-treat considerando as pacientes que perderam seguimento como curadas (p=0,004); e na comparação de intention-to-treat considerando as pacientes excluídas como não curadas, o grupo TC+TMAP foi superior em relação ao grupo TMAP (p=0,044). Observou-se similar redução dos sintomas urinários (frequência urinária, urgência miccional, IUU, noctúria e troca de protetor para perda de urina nos três grupos estudados após 12 semanas de tratamento comparado com os sintomas iniciais (p<0,05). O grupo TC+TMAP apresentou escore do OAB-V8 significativamente menor do que os grupos TMAP (p=0,040) e TC (p=0,027). Ainda, observa-se superioridade da performance muscular nos grupos TC+TMAP (p=0,001) e TMAP (p=0,002), bem como melhor endurance nos grupos TC+TMAP (0,004) e TMAP (p=0,0004), e ainda no número de contrações rápidas nos grupos TC+TMAP (p=0,004) e TMAP (p=0,005) quando comparados ao grupo TC. Não observamos diferença entre os grupos TC+TMAP e TMAP em relação ao número de séries de exercícios realizados semanalmente após o 1º, 2º e 3º meses de tratamento (p>0,05). A frequência nas sessões ambulatoriais foi semelhante entre os grupos, variando de 5 a 6 sessões em 12 semanas de tratamento. Os grupos do estudo foram semelhantes em relação à cura subjetiva. Conclusão: A combinação do tratamento comportamental com o treinamento dos músculos do assoalho pélvico mostrou-se mais efetivo do que as terapias isoladas no manejo das mulheres com SBH: maior taxa de cura objetiva e melhor qualidade de vida.
Objective: To evaluate and compare the effects of behavioral treatment (BT) (which includes life style techniques, educational program, bladder training, suppression of urinary urgency and pelvic floor muscle exercises) associated with pelvic floor muscle training (PFMT), BT and PFMT isolated in women with overactive bladder syndrome (OBS). Metods: A randomized, controlled clinical trial was carried out in a single center with supervised intervention. One hundred and ten women with OAB proven by the voiding diary and the Overactive Bladder Questionnaire V8 (OAB-V8) were randomized in to three groups: BT; PFMT; or BT+PFMT. The primary objective was to evaluate the objective cure rate, considering a composite criterion consisting of: OAB-V8 score <8 and absence of episodes of urgency urinary incontinence (UUI) in the voiding diary. The secondary outcomes were to evaluate urinary symptoms (using the voiding diary and OAB-V8), muscle function (by NEW PERFECT scale), outpatient and home adherence to exercise, and subjective cure (report of satisfaction and no desire for new treatment). The non-parametric Kruskal-Wallis, Likelihood Ratio, Chi-square, and Mann-Whitney tests were used for statistical analysis with p value <0.05 as significant. Results: The percentage of objective cure was significantly higher in the BT+PFMT group compared to the PFMT and BT group in the per protocol (p=0.006) and intention-to-treat analyses, considering patients who were lost to follow-up as cured (p=0.004); and in the intention-to-treat comparison considering patients excluded as not cured, the BT+PFMT group was superior to the PFMT group (p=0.044). A similar reduction in urinary symptoms (urinary frequency, urinary urgency, UUI, nocturia and change of protector for urine loss) was observed in the three groups studied after 12 weeks of treatment compared with the initial symptoms (p<0.05). BT+PFMT presented a significantly lower OAB-V8 score than the PFMT (p=0.040) and BT (p=0.027) groups. Furthermore, superior muscular performance was observed in the BT+PFMT (p=0.001) and PFMT groups (p=0.002), as well as better endurance in the BT+PFMT (0.004) and PFMT (p=0.0004) groups, and in the number of fast contractions in the BT+PFMT (p=0.004) and PFMT (p=0.005) when compared to the BT group. We observed no difference between the BT+PFMT and PFMT groups in relation to the number of sets of exercises performed weekly after the 1st, 2nd, and 3rd months of treatment (p>0.05). Outpatient sessions were similar between groups, ranging from 5 to 6 sessions over 12 weeks of treatment. The study groups were similar regarding subjective cure. Conclusion: In general, the combination of behavioral treatment with PFMT proved to be more effective than isolated therapies in the management of women with OBS: higher objective cure rate and better quality of life.
Objective: To evaluate and compare the effects of behavioral treatment (BT) (which includes life style techniques, educational program, bladder training, suppression of urinary urgency and pelvic floor muscle exercises) associated with pelvic floor muscle training (PFMT), BT and PFMT isolated in women with overactive bladder syndrome (OBS). Metods: A randomized, controlled clinical trial was carried out in a single center with supervised intervention. One hundred and ten women with OAB proven by the voiding diary and the Overactive Bladder Questionnaire V8 (OAB-V8) were randomized in to three groups: BT; PFMT; or BT+PFMT. The primary objective was to evaluate the objective cure rate, considering a composite criterion consisting of: OAB-V8 score <8 and absence of episodes of urgency urinary incontinence (UUI) in the voiding diary. The secondary outcomes were to evaluate urinary symptoms (using the voiding diary and OAB-V8), muscle function (by NEW PERFECT scale), outpatient and home adherence to exercise, and subjective cure (report of satisfaction and no desire for new treatment). The non-parametric Kruskal-Wallis, Likelihood Ratio, Chi-square, and Mann-Whitney tests were used for statistical analysis with p value <0.05 as significant. Results: The percentage of objective cure was significantly higher in the BT+PFMT group compared to the PFMT and BT group in the per protocol (p=0.006) and intention-to-treat analyses, considering patients who were lost to follow-up as cured (p=0.004); and in the intention-to-treat comparison considering patients excluded as not cured, the BT+PFMT group was superior to the PFMT group (p=0.044). A similar reduction in urinary symptoms (urinary frequency, urinary urgency, UUI, nocturia and change of protector for urine loss) was observed in the three groups studied after 12 weeks of treatment compared with the initial symptoms (p<0.05). BT+PFMT presented a significantly lower OAB-V8 score than the PFMT (p=0.040) and BT (p=0.027) groups. Furthermore, superior muscular performance was observed in the BT+PFMT (p=0.001) and PFMT groups (p=0.002), as well as better endurance in the BT+PFMT (0.004) and PFMT (p=0.0004) groups, and in the number of fast contractions in the BT+PFMT (p=0.004) and PFMT (p=0.005) when compared to the BT group. We observed no difference between the BT+PFMT and PFMT groups in relation to the number of sets of exercises performed weekly after the 1st, 2nd, and 3rd months of treatment (p>0.05). Outpatient sessions were similar between groups, ranging from 5 to 6 sessions over 12 weeks of treatment. The study groups were similar regarding subjective cure. Conclusion: In general, the combination of behavioral treatment with PFMT proved to be more effective than isolated therapies in the management of women with OBS: higher objective cure rate and better quality of life.
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Citação
MATIAS, Mayanni Magda Pereira. Efeitos do tratamento comportamental e do treinamento dos músculos do assoalho pélvico na síndrome da bexiga hiperativa: ensaio clínico randomizado controlado. 2023. 70 f. Dissertação (Mestrado em Ginecologia) - Escola Paulista de Medicina, Universidade Federal de São Paulo (UNIFESP). São Paulo, 2023.