Vaginal stenosis is one of the most prevalent side effects of pelvic radiation, affecting about one third of women. In this randomized controlled trial, the effect of a pelvic physiotherapy protocol on an incidence rate of vaginal stenosis in women with gynecological cancer undergoing gynecological brachytherapy. In addition, the investigators will explore an improvement in quality of life, sexuality, and contractile function of the pelvic floor muscles.
Tis study will be conducing in a reference hospital to oncology treatment were mane patients with gynecologic cancer are management on radiotherapy services. The aim of this work is evaluated the effects of the pelvic physiotherapy (PP) on the more prevalent constriction pathology (vaginal stenosis) secondary to the brachytherapy. The PP will be conduced by three months after the radiotherapy starts and the incidence of the vaginal stenosis will be compared with a control group throughout six months of fallow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
160
1\) daily pelvic floor muscle training (PFMT).
1\) daily vaginal dilator therapy (10 to 15 minutes) and 2) usual care management.
Comitê de Ética em Pesquisa - Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGVaginal Stenosis
Vaginal stenosis will be evaluated before the first brachytherapy and twelve months after. Considered according to the study of Kirchheiner et al., (2016) that used the Common Terminology Criteria for Adverse Events (CTCAE v3.0). Vaginal stenosis will also be considered as the narrowing of the vaginal canal that makes it impossible to introduce the number 1 acrylic gynecological speculum through the vaginal introitus.
Time frame: With completion of the study, predicted 15 months after the start of the study.
Quality of life
The quality of live will be evaluated before the first brachytherapy and twelve months after through the application of the Quality of Life questionnaire European Organization for Research and Treatment of Cancer - EORTC QLQ-C30.
Time frame: With completion of the study, predicted 15 months after the start of the study.
Sexuality
The sexuality will be evaluated before the first brachytherapy and twelve months after through the application of the questionnaire The Female Sexual Function Index (FSFI).
Time frame: With completion of the study, predicted 15 months after the start of the study.
Muscle activity and contractile function of the pelvic floor
Measurement of pelvic floor activity will be evaluated before the first brachytherapy and twelve months after through surface electromyography (EMG), which is able to record the extracellular bioelectric activity generated by muscle fibers, through the electromyographic biofeedback Miotool 400 from Miotec.
Time frame: With completion of the study, predicted 15 months after the start of the study.
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