Evaluation of Clinical Efficacy of the Sensifemme® Device in the Diagnosis of Breast Lump

Abstract

INTRODUCTION: Breast cancer is the most common malignant tumor among women after no melanoma skin cancer and an important cause of cancer mortality. Secondary prevention strategies emphasize breast self-examination, clinical breast examination and mammography. Mammography is the major method for early detection of disease. Self-examination and clinical breast examination have low sensitivity and there is no evidence to decrease mortality from breast cancer. The Sensifemme® device is a glove with three layers of polyurethane with a thickness of 0.5 mm and has a mineral oil interposed between these layers. Between the inner and middle layer, there is enough space for the examiner s hand to be introduced during the use of the device. The glove was developed to allow greater slippage examiner s hand on the breast, which would increase the sensitivity of clinical examination and self-examination. The aim of this study was to evaluate the clinical efficacy of the Sensifemme® device in the diagnosis of breast lump. MATERIALS AND METHODS: Prospective, randomized, double-blind study in which 75 patients in breast diseases outpatient of Department of Gynecology of Escola Paulista de Medicina from Universidade Federal de Sao Paulo, were randomized into two groups; the patients in group 1 were first examined by Sensifemme® device and group 2 were examined without device as control group. Subsequently all patients underwent bilateral ultrasound to confirm or exclude the physical examination findings. RESULTS: The mean age of patients was 43 years old and 90 breast lumps were detected after clinical examination and ultrasound, distributed in 74% solid nodules and 26% cystic nodules. In the group Sensifemme® device sensitivity was 74%, specificity was 61.5% and accuracy was 71.5%. In the control group was, respectively, 63%, 65. 3% and 63. 7%. The effectiveness of the Sensifemme® device was significantly higher in the nodules smaller than 2 cm and in cases that the distance between skin and lump was 1 to 2 centimeters. DISCUSSION: The self-examination and clinical breast examination are not sufficient for breast cancer screening. However, breast awareness may alert the patients about any changes in the breasts and lead them to a medical service earlier. The self-examination is recommended with the practice of health education and knowledge of the body. The Sensifemme® device showed positive impact by helping to improve the accuracy of clinical examination. CONCLUSION: The Sensifemme® device was more effective than the clinical examination performed without the device in the diagnosis of breast lump, which can facilitate the detection of breast lesions and increase the sensitivity of clinical examination, without reducing the importance of mammography.