Treatment of Endometriosis stage III and IV with dienogeste: prospective study

• Grant number: 13/05407-1
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: July 01, 2013
• End date: June 30, 2014
• Field of knowledge: Health Sciences - Medicine - Maternal and Child Health
• Principal Investigator: Cristina Laguna Benetti Pinto
• Grantee: Laura Paraguai Donati
• Host Institution: Centro de Atenção Integral à Saúde da Mulher (CAISM). Hospital da Mulher Professor Doutor José Aristodemo Pinotti. Universidade Estadual de Campinas (UNICAMP). Campinas , SP, Brazil

Abstract

Endometriosis is a chronic benign disease with high prevalence in the female population and with a major impact on quality of life. Endometriosis stage III and IV often requires surgical treatment of high complexity with high rates of morbidity and possibility of disease recurrence. Currently, when possible conservative treatment is indicated drug. Objective: to evaluate the clinical treatment using dienogeste to treat endometriosis stage III and IV. Will assess the actions of dienogeste, a new therapeutic option in the Brazilian market, in controlling symptoms, lesion size, influence on quality of life and sexuality. Study design: prospective cohort study. Subjects and Methods: will be evaluated women with endometriosis stage III and IV endometriosis treated at the clinic of the Department of Obstetrics and Gynecology, Faculty of Medical Sciences, UNICAMP, in the period April to September 2013, with a minimum sample size of 18 patients. Will be compared clinical symptoms of pelvic pain, dysmenorrhea, dyspareunia, pain on defecation or urination, quality of life, sexuality, lesion size evaluated by ultrasound before and after 6 months of treatment. Will be applied questionnaires to assess quality of life (WHOQOL-bref) and sexuality (Female Sexual Function Index-IFSF). Women will be followed as outpatients 2, 4 and 6 months after beginning treatment. Statistical analysis: the quantitative data will be evaluated by paired Student t test (Wilcoxon paired or if the data distribution is not normal), and Mean, standard deviation and median, and the qualitative data through the chi-square McNemar, as well as their frequencies. It will be taken on a significance level of 5% and the software used for analysis will be the SAS version 9.2. (AU)