Objective: To assess the efficacy and safety of ultra-low dose 0.005% estriol vaginal gel in women with breast cancer receiving nonsteroidal aromatase inhibitors (NSAIs) and experiencing treatment-related vulvovaginal symptoms and signs. Methods: Women with hormone receptor-positive early breast cancer receiving NSAIs were randomized to either estriol vaginal gel or placebo for 12 weeks. Vaginal maturation, vaginal pH, and total and individual scores of symptoms and signs of vulvovaginal atrophy were assessed at baseline and at weeks 3 and 12; sexual functioning was also evaluated using the Female Sexual Functioning Index (FSFI) questionnaire, as well as circulating estrogens, follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Results: Sixty-one women with a mean age of 59 years were included: 50 received 0.005% estriol vaginal gel and 11 received placebo. Active treatment significantly improved maturation value and pH, vaginal dryness and global scores of symptoms and signs. Active treatment also increased the total FSFI score and all the FSFI domains, with the exception of pain. Small oscillations were observed in FSH and LH, which remained within the postmenopausal range. Estriol levels increased initially and normalized by week 12, and estradiol and estrone remained mostly undetectable throughout the study. Conclusions: Ultra-low dose 0.005% estriol vaginal gel showed efficacy in improving the symptoms and signs of vulvovaginal atrophy. These results, together with minimal oscillations in hormonal levels throughout the treatment, support the use of ultra-low dose 0.005% estriol vaginal gel as a treatment option for vulvovaginal atrophy in women with breast cancer receiving NSAIs with an indication for treatment with vaginal estrogens. Video Summary: http://links.lww.com/MENO/A531.
INTRODUCTION: The Objective was to investigate the incidence of lymphedema after breast cancer treatment and to analyze the risk factors involved in a tertiary level hospital. METHODS: Prospective longitudinal observational study over 3 years post-breast surgery. 232 patients undergoing surgery for breast cancer at our institution between September 2013 and February 2018. Sentinel lymph node biopsy (SLNB) or axillary lymphadenectomy (ALND) were mandatory in this cohort. In total, 201 patients met the inclusion criteria and had a median follow-up of 31 months (range, 1–54 months). Lymphedema was diagnosed by circumferential measurements and truncated cone calculations. Patients and tumor characteristics, shoulder range of motion limitation and local and systemic therapies were analyzed as possible risk factors for lymphedema. RESULTS: Most cases of lymphedema appeared in the first 2 years. 13.9% of patients developed lymphedema: 31% after ALND and 4.6% after SLNB (p < 0.01), and 46.7% after mastectomy and 11.3% after breast-conserving surgery (p < 0.01). The lymphedema rate increased when axillary radiotherapy (RT) was added to radical surgery: 4.3% for SLNB alone, 6.7% for SLNB + RT, 17.6% for ALND alone, and 35.2% for ALND + RT (p < 0.01). In the multivariate analysis, the only risk factors associated with the development of lymphedema were ALND and mastectomy, which had hazard ratios (95% confidence intervals) of 7.28 (2.92–18.16) and 3.9 (1.60–9.49) respectively. CONCLUSIONS: The main risk factors for lymphedema were the more radical surgeries (ALND and mastectomy). The risk associated with these procedures appeared to be worsened by the addition of axillary radiotherapy. A follow-up protocol in patients with ALND lasting at least two years, in which special attention is paid to these risk factors, is necessary to guarantee a comprehensive control of lymphedema that provides early detection and treatment.
Aims:The aim of the study is to assess the feasibility of ambulatory stress urinary incontinence (SUI) surgery using the MiniArc Precise single-incision urethral sling without increasing the number of complications.Settings and Design:This was a retrospective observational study of prospectively collected data carried out in a Tertiary Referral Hospital in Barcelona, Spain.Materials and Methods:Forty patients diagnosed with SUI or stress predominant mixed urinary incontinence (MUI) treated surgically between November 2011 and November 2013. The MiniArc Precise® sling was inserted under local anesthesia in the ambulatory setting.Statistical Analysis Used:Descriptive statistics included frequencies and percentages for categorical variables and mean and range for quantitative variables. The statistical package used was SPSS version 17.0.Results:Urodynamic studies showed SUI in 78% of cases and stress predominant MUI in 17%. Clinical findings included SUI in 56% of cases and MUI in 44%, with positive stress tests in all participants. The mean intraoperative pain (1–10 Visual Analog Scale) was 2. All patients were satisfied with the use of local anesthesia in the outpatient setting. Perioperative complications did not occur. One case of urinary retention and two cases of urinary tract infection (UTI) developed within this 1st month after operation and were successfully managed conservatively. Midterm complications included eight cases of UTI and four de novo urge incontinence.Conclusions:Placement of the MiniArc Precise sling under local anesthesia is a feasible and safe technique, which when carried out by an experienced surgeon allows to be done as an outpatient basis without increasing the rate of postprocedural complications.
Introduction: We aimed to investigate the incidence of lymphedema after breast cancer treatment, to analyze the risk factors involved, and to improve existing protocols for the prevention of lymphedema. Patients and methods: This was a prospective cohort study of 232 patients undergoing surgery for breast cancer at our institution between September 2013 and February 2018. Sentinel lymph node biopsy (SLNB) or axillary lymphadenectomy (ALND) were mandatory in this cohort. Lymphedema was diagnosed by circumferential measurements and truncated cone calculations. Patients and tumor characteristics, as well as local and systemic therapies, were analyzed as possible risk factors for lymphedema. Results: In total, 201 patients met the inclusion criteria and had a median follow-up of 31 months (range, 1–54 months). Most cases of lymphedema cases appeared in the first 2 years. 13.9% developed lymphedema: 31% after ALND and 4.6% after SLNB (p < 0.01), and 46.7% after mastectomy and 11.3% after breast-conserving surgery (p < 0.01). The lymphedema rate increased when axillary radiotherapy (RT) was added to radical surgery: 4.3% for SLNB alone, 6.7% for SLNB + RT, 17.6% for ALND alone, and 35.2% for ALND + RT (p < 0.01). In the multivariate analysis, the only risk factors associated with the development of lymphedema were ALND and mastectomy, which had hazard ratios (95% confidence intervals) of 7.28 (2.92–18.16) and 3.9 (1.60–9.49), respectively. Conclusions: The main risk factors for lymphedema were the most radical surgeries (ALND and mastectomy), while the risk associated with these appeared to be worsened by the addition of axillary radiotherapy. A follow-up protocol in patients with ALND for at least two years, where these risk factors are recognized, is necessary to guarantee a comprehensive control of lymphedema that provides early detection and treatment.
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