Safety and efficacy of a prebubic monofilamenta sling : prospective study

Orientadores: Cassio Luis Zanettini Riccetto, Paulo Cesar Rodrigues PalmaDissertação (mestrado) - Universidade Estadual de Campinas, Faculdade de CienciasResumo: Objetivos: Com o objetivo de avaliar os resultados cirúrgicos e de modificação na qualidade de vida de mulheres submetidas ao tratamento de incontinência urinária de esforço com sling sintético de polipropileno com abordagem pré-púbica. Métodos: Foi desenvolvido estudo prospectivo, de intervenção, com seguimento por seis meses, envolvendo 20 pacientes, com idade mínima de 21 anos e com diagnóstico de incontinência urinária de esforço realizado no Serviço de Uroginecologia do Hospital das Clínicas da Universidade Estadual de Campinas, Campinas, São Paulo, com base em dados clínicos, urodinâmicos e de Pad-test compatíveis, as quais expressaram a vontade de se submeter à implantação de sling para correção cirúrgica; não gestantes; sem doença ou qualquer condição que pudesse comprometer o resultado da cirurgia, tal como: distúrbio de coagulação sanguínea, obstrução do trato urinário superior, insuficiência renal, comprometimento do sistema imune, infecção urinária ou vaginal; não submetidas a procedimento de sling sintético prévio; que concordaram em participar do estudo, por meio da assinatura do Termo de Consentimento Livre Esclarecido e em responder os questionários King's Health Questionnaire (KHQ) e International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) antes da cirurgia e decorridos seis meses do procedimento. Para o tratamento de incontinência urinária de esforço, empregou-se tela manufaturada em fibras de polipropileno, classe I, monofilamentar com 42 µm de diâmetro e macroporos maiores que 75 mm, por abordagem pré-púbica. As variáveis estudadas incluíram: idade, avaliação urodinâmica, Pad-test e resultados dos questionários King's Health Questionnaire (KHQ) e International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) . Os dados foram organizados por meio do programa Epi-INfo versão 6.04d e analisados com o programa Statistical Package for Social Sciences (SPSS), versão 13.0. As variáveis nominais e ordinais foram expressas em distribuição de freqüências absolutas e relativas e as quantitativas, pelos parâmetros da Estatística Descritiva. Para comparação dos parâmetros objetivos uroginecológicos e de qualidade de vida aferida pelos questionários International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) e King's Health Questionnaire (KHQ), do período pré-operatório e decorridos seis meses do procedimento cirúrgico, empregou-se teste de diferença de médias, em nível de significância de 0,05, determinando-se o intervalo de confiança em nível de confiança de 95%. Resultados: Comparando a avaliação pré-operatória àquela decorridos seis meses do procedimento cirúrgico, verificou-se redução significante da perda de urina mensurada através do Pad-test (p<0,001). A pressão de perda sob esforço foi negativa em 90% das pacientes decorridos seis meses da cirurgia. Os demais parâmetros urodinâmicos da cistometria não foram alterados significativamente comparando antes e depois da cirurgia. O fluxo máximo miccional despida de significância estatística (p = 0,034). Houve melhora de todos os parâmetros subjetivos avaliados pelo International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), com significância estatística da freqüência de perda de urina (0,009) e menor interferência na vida da pacientes (p= 0,001), assim como de todos os domínios do King's Health Questionnaire (KHQ). Houve 6 (30%) casos de complicações, que consistiram em extrusão vaginal do sling, instituindo-se tratamento cirúrgico por retirada do segmento da tela exposta e síntese da mucosa vaginal. Conclusão: Embora tenha havido a necessidade de interromper este estudo devido ao alto índice de complicações, confirmou-se o fato de ser a incontinência urinária um evento que compromete a qualidade de vida das pacientes exercendo tal impacto que, mesmo diante do insucesso do procedimento terapêutico, a avaliação subjetiva foi favorável, decorridos seis meses da cirurgiaAbstract: Objectives: A prospective study of intervention was developed aiming to evaluate the surgical results and impact in the quality of life of women submitted to stress urinary incontinence treatment with polypropylene synthetic sling with prepubic approach. Methods: Twenty patients were included in this study. Diagnosis of stress urinary incontinence were based on clinical data, urodynamics and Pad-test. Inclusion criteria included: minimum age of 21 years; non pregnant; without illness or any condition that could compromise surgery's result (sanguineous coagulation disorders, superior urinary tract obstruction, renal insufficiency, immune system disorder, urinary or vaginal infection); abcense of previous synthetic sling procedure; agreement to participate of the study, by means of Free Consent Term signature and to answer to the questionnaires King's Health Questionnaire (KHQ) e International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) before the surgery and after six months of the procedure. Its was used a sling made of staple fibres of polypropylene, type I, monofilamentar (42 µm diameter) and macropores. All the procedures were performed under spinal anesthesia. The sling was placed and adjusted in midurethral area with minimal periurethral dissection. The proper tension and fixation was achieved by passing the sling arms through the prepubic subcutaneous fat tissue. The variables studied included: age; urodynamic evaluation; Pad-test; King's Health Questionnaire; and International Consultation on Incontinence Questionnaire. Data were recorded using Epi-INfo version 6.04d software and analyzed with Statistical Package for Social Sciences (SPSS), version 13.0. The nominal and ordinal variables were express in absolute and relative frequency distribution and the quantitative ones by parameters of descriptive statistics. Difference of means test was used (significance level of 0,05, 95% confidence interval) for comparison of the urogynecologic objective parameters and quality of life surveyed by ICIQ and KHQ questionnaires, of pre-operative and six months post-operative evaluation. Results: Comparing pre-surgical evaluations with those after six months of the surgical procedure, there were significant reduction of urine loss assessed by the pad-test (p<0,001). Comparing urodynamics evaluations before and after surgical procedure 90% patients no there were of urine loss. Other urodynamics parameters no there were significant alterations. The max flow there was significant reduction (p=0,034). There was an improvement of all subjective parameters evaluated by ICIQ-SF, with significance for frequency of urine loss (0,009) and minor interference in life (p= 0.001), as well as of all KHQ domains. Six patients (20%) presented complications which consisted of vaginal exposition of the sling. All of them were corrected surgically by excision of the mesh and suture of the vaginal wall. The study was interrupted after six months of follow up due to the high frequency of adverse effects. Conclusion: Although the decision of interrupting the study due to the high index of complication, it allowed to confirm that stress urinary incontinence compromises the quality of life of the patients significantly, and the treatmet could promote an improvement in the quality of life, even when objective results were unfavourableMestradoCirurgiaMestre em Cirurgi

Leiomioma uretral durante a gravidez: relato de caso Urethral leiomyoma during pregnancy: a case report

<abstract language="eng">The authors report a case of urethral leiomyoma diagnosed during pregnancy, which was conservatively treated up to the 38th week, when the pregnancy was interrupted. Thirty days after delivery, exeresis of the lesion was performed from the upper border of the urethral meatus and sutured with interrupted delayed-absorbable suture. The patient evolved favorably and presented no lesion recurrence during three months of follow up

[urethral Leiomyoma During Pregnancy: A Case Report].

The authors report a case of urethral leiomyoma diagnosed during pregnancy, which was conservatively treated up to the 38th week, when the pregnancy was interrupted. Thirty days after delivery, exeresis of the lesion was performed from the upper border of the urethral meatus and sutured with interrupted delayed-absorbable suture. The patient evolved favorably and presented no lesion recurrence during three months of follow up.39560-

Urethral leiomyoma during pregnancy: a case report

The authors report a case of urethral leiomyoma diagnosed during pregnancy, which was conservatively treated up to the 38th week, when the pregnancy was interrupted. Thirty days after delivery, exeresis of the lesion was performed from the upper border of the urethral meatus and sutured with interrupted delayed-absorbable suture. The patient evolved favorably and presented no lesion recurrence during three months of follow up.56056