Efficacy of Sacrospinous Fixation or Uterosacral Ligament Suspension for Pelvic Organ Prolapse in Stages III and IV: Randomized Clinical Trial.

OBJECTIVE: To evaluate the efficacy and outcomes of the surgical treatment for pelvic organ prolapse (POP) in stages III and IV by sacrospinous ligament fixation (SSLF) or uterosacral ligament suspension (USLS) by comparing anatomical and subjective cure rates and quality-of-life parameters (through the version validated for the Portuguese language of the Prolapse Quality of Life [P-QoL] questionnaire) under two definitions: genital prolapse Ba, Bp, and C < -1 (stage I) and Ba, Bp, and C ≤ 0 (stage II). MATERIALS AND METHODS: After we obtained approval from the Ethics Committee (under CAAE 0833/06) and registered the study in ClinicalTrials.gov (NCT01347021), 51 patients were randomized into two groups: the USLS group (N = 26) and the SSLF group (N = 25), with follow-up 6 and 12 months after the procedures. RESULTS: There was a significant improvement in the P-QoL score and anatomical measurements of all compartments in both groups after 12 months (p < 0.001). The anatomical cure rates in the USLS and SSLF groups, considering stage 1, were of 34.6% and 40% (anterior) respectively; of 100% both for groups (apical); and of 73.1% and 92% (posterior) respectively. The rates of adverse outcomes were of 42% (N = 11) and 36% (N = 11) for the USLS and SSLF groups respectively (p = 0.654), and those outcomes were excessive bleeding, bladder perforation (intraoperative) or gluteal pain, and urinary infection (postoperative), among others, without differences between the groups. CONCLUSION: High cure rates in all compartments were observed according to the anatomical criterion (stage I), without differences in P-QoL scores and complications either with USLS or SSLF for the surgical treatment of accentuated POP.

OBJETIVO: Avaliar a eficácia e os resultados do tratamento cirúrgico para prolapso de órgãos pélvicos (POP) nos estágios III e IV, por meio da técnica de fixação do ligamento sacroespinal (FLSE) ou suspensão do ligamento útero-sacro (SLUS), ao comparar os índices de cura anatômicos, subjetivos, e os parâmetros de qualidade de vida (por meio do questionário Prolapse Quality of Life [P-QoL] validado para a língua portuguesa) sob duas definições: prolapso genital Ba, Bp e C < −1 (estágio I) e Ba, Bp e C ≤ 0 (estágio II). MATERIAIS E MéTODOS: Após aprovação do Comitê de Ética (CAAE 0833/06) e registro no ClinicalTrials.gov (NCT01347021), 51 pacientes foram randomizadas em dois grupos: grupo SLUS (N = 26) e (2) grupo FLSE (N = 25), com seguimento de 6 e 12 meses. RESULTADOS: Houve melhora significativa nas pontuações no P-QoL e nas medidas anatômicas de todos os compartimentos em ambos os grupos após 12 meses (p < 0,001). As taxas de cura anatômica nos grupos SLUS e FLSE , considerando o estágio 1, foram de 34,6% e 40% (anterior), respectivamente; de 100% em ambos os grupos (apical); e de 73,1% e 92% (posterior), respectivamente. As taxas de resultados adversos foram de 42% (N = 11) e 36% (N = 11), respectivamente, nos grupos SLUS e FLSE (p = 0,654), e elas foram sangramento excessivo, perfuração da bexiga (intraoperatória) ou dor glútea, e infecção urinária (pós-operatória), entre outras, sem diferenças entre os grupos. CONCLUSãO: Altas taxas de cura em todos os compartimentos foram observadas segundo critério anatômico (estágio I), sem diferença quanto às pontuações no P-QoL e às complicações tanto com SLUS quanto com FLSE para o tratamento cirúrgico de POP acentuado.

Quantification of Vitamin D at Different Levels of Clinical Worsening of COVID-19.

INTRODUCTION AND AIM: Vitamin D is the name given to a group of lipid-soluble steroidal substances of physiological importance in the body, especially in bone metabolism. The active form of vitamin D is believed to have immunomodulatory effects on immune system cells, especially T lymphocytes, as well as on the production and action of several cytokines and on the expression of potent antimicrobial peptides in epithelial cells that line the respiratory tract, playing an important role in protecting the lung from infections. The aim of this study was to assess vitamin D levels in patients with COVID-19 in healthcare service and to verify that these levels are adequate to protect the progression of this infection. METHODS: The aim of this observational study was to evaluate the serum concentration of vitamin D in 300 patients suspected of being infected with COVID-19, treated at Basic Health Units (BHUs) and at the Hospital Complex in the municipality of São Bernardo do Campo. RESULTS: 294 patients were included, 195 (66%) of which tested positive for COVID-19 and 99 (34%) negative for COVID-19. Among the patients in the positive group, 163 patients were in the mild group (84%); 22 patients in the moderate group (11%); 8 patients in the severe group (4%), and 2 patients in the deceased group (1%). CONCLUSION: For the patients in this study, no association was observed for the protective factor of vitamin D against COVID-19 infection, and its role in controlling the clinical staging of the disease was not verified.

Rehabilitation of People With Chronic Spinal Cord Injury Using a Laparoscopically Implanted Neurostimulator: Impact on Mobility and Urinary, Anorectal, and Sexual Functions.

OBJECTIVES: This study aimed to assess the impact of the laparoscopic implantation of neuromodulation electrodes (Possover-LION procedure) on mobility and on sexual, urinary, and anorectal functions of people with chronic spinal cord injury (SCI). MATERIAL AND METHODS: Longitudinal analysis of 30 patients with chronic SCI (21 ASIA impairment scale (AIS) A, eight AIS B, and one AIS C) submitted to the Possover-LION procedure for bilateral neuromodulation of femoral, sciatic, and pudendal nerves. Assessments were performed before the surgical procedure and at 3, 6, and 12 months postoperatively. The primary outcome was evolution in walking, measured by the Walking Index for Spinal Cord Injury score, preoperatively and at 12 months. Secondary outcomes were changes in overall mobility (Mobility Assessment Tool for Evaluation of Rehabilitation score), urinary function and quality of life (Qualiveen questionnaire), and bowel (time for bowel emptying proceedings and Wexner's Fecal Incontinence Severity Index [FISI]) and sexual functions (International Index of Erectile Function for men and Female Sexual Function Index for women). Surgical time, intraoperative bleeding, and perioperative complications were also recorded. RESULTS: Qualitatively, 18 of 25 (72%) patients with thoracic injury and 3 of 5 (60%) patients with cervical injury managed to establish a walker-assisted gait at one-year follow-up (p < 0.0001). A total of 11 (47.8%) have improved in their urinary incontinence (p < 0.0001), and seven (30.4%) improved their enuresis (p = 0.0156). The FISI improved from a median of 9 points preoperatively to 5.5 at 12 months (p = 0.0056). Of note, 20 of 28 (71.4%) patients reported an improvement on genital sensitivity at 12 months postoperatively (p < 0.0001), but this was not reflected in sexual quality-of-life questionnaires. CONCLUSIONS: Patients experienced improved mobility and genital sensitivity and a reduction in the number of urinary and fecal incontinence episodes. By demonstrating reproducible outcomes and safety, this study helps establish the Possover-LION procedure as an addition to the therapeutic armamentarium for the rehabilitation of patients with chronic SCI. CLINICAL TRIAL REGISTRATION: This study was registered at the WHO Clinical Trials Database through the Brazilian Registry of Clinical Trials-REBEC (Universal Tracking Number: U1111-1261-4428).

Efficacy of Sacrospinous Fixation or Uterosacral Ligament Suspension for Pelvic Organ Prolapse in Stages III and IV: Randomized Clinical Trial / Eficácia da fixação sacroespinhal ou da suspensão do ligamento útero-sacro no prolapso de órgãos pélvicos nos estágios III e IV: Ensaio clínico randomizado

Abstract Objective To evaluate the efficacy and outcomes of the surgical treatment for pelvic organ prolapse (POP) in stages III and IV by sacrospinous ligament fixation (SSLF) or uterosacral ligament suspension (USLS) by comparing anatomical and subjective cure rates and quality-of-life parameters (through the version validated for the Portuguese language of the Prolapse Quality of Life [P-QoL] questionnaire) under two definitions: genital prolapse Ba, Bp, and C< −1 (stage I) and Ba, Bp, and C ≤ 0 (stage II). Materials and Methods After we obtained approval from the Ethics Committee (under CAAE 0833/06) and registered the study in ClinicalTrials.gov (NCT 01347021), 51 patients were randomized into two groups: the USLS group (N = 26) and the SSLF group (N = 25), with follow-up 6 and 12 months after the procedures. Results There was a significant improvement in the P-QoL score and anatomical measurements of all compartments in both groups after 12 months (p< 0.001). The anatomical cure rates in the USLS and SSLF groups, considering stage 1, were of 34.6% and 40% (anterior) respectively; of 100% both for groups (apical); and of 73.1% and 92% (posterior) respectively. The rates of adverse outcomes were of 42% (N = 11) and 36% (N = 11) for the USLS and SSLF groups respectively (p= 0.654), and those outcomes were excessive bleeding, bladder perforation (intraoperative) or gluteal pain, and urinary infection (postoperative), among others, without differences between the groups. Conclusion High cure rates in all compartments were observed according to the anatomical criterion (stage I), without differences in P-QoL scores and complications either with USLS or SSLF for the surgical treatment of accentuated POP.

Resumo Objetivo Avaliar a eficácia e os resultados do tratamento cirúrgico para prolapso de órgãos pélvicos (POP) nos estágios III e IV, por meio da técnica de fixação do ligamento sacroespinal (FLSE) ou suspensão do ligamento útero-sacro (SLUS), ao comparar os índices de cura anatômicos, subjetivos, e os parâmetros de qualidade de vida (por meio do questionário Prolapse Quality of Life [P-QoL] validado para a língua portuguesa) sob duas definições: prolapso genital Ba, Bp e C< −1 (estágio I) e Ba, Bp e C ≤ 0 (estágio II). Materiais e Métodos Após aprovação do Comitê de Ética (CAAE 0833/06) e registro no ClinicalTrials.gov (NCT 01347021), 51 pacientes foram randomizadas em dois grupos: grupo SLUS (N = 26) e (2) grupo FLSE (N = 25), com seguimento de 6 e 12 meses. Resultados Houve melhora significativa nas pontuações no P-QoL e nas medidas anatômicas de todos os compartimentos em ambos os grupos após 12 meses (p< 0,001). As taxas de cura anatômica nos grupos SLUS e FLSE , considerando o estágio 1, foram de 34,6% e 40% (anterior), respectivamente; de 100% em ambos os grupos (apical); e de 73,1% e 92% (posterior), respectivamente. As taxas de resultados adversos foram de 42% (N = 11) e 36% (N = 11), respectivamente, nos grupos SLUS e FLSE (p= 0,654), e elas foram sangramento excessivo, perfuração da bexiga (intraoperatória) ou dor glútea, e infecção urinária (pós-operatória), entre outras, sem diferenças entre os grupos. Conclusão Altas taxas de cura em todos os compartimentos foram observadas segundo critério anatômico (estágio I), sem diferença quanto às pontuações no P-QoL e às complicações tanto com SLUS quanto com FLSE para o tratamento cirúrgico de POP acentuado.

Three-dimensional Printer Molds for Vaginal Agenesis: An Individualized Approach as Conservative Treatment / Moldes de impressão tridimensionais para agenesia vaginal: Uma abordagem individualizada como tratamento conservador

Abstract Objective The aim of this study was to evaluate the use of vaginal molds, made with three-dimensional (3D) printing, for conservative treatment through vaginal dilation in patients with vaginal agenesis (VA). Methods A total of 16 patients with a diagnosis of VA (Mayer-Rokitansky-Küster-Hauser syndrome, total androgen insensitivity syndrome, and cervicovaginal agenesis) from the Federal University of São Paulo were selected. Device production was performed in a 3D printer, and the polymeric filament of the lactic polyacid (PLA) was used as raw material. A personalized treatment was proposed and developed for each patient. Results There were 14 patients who reached a final vaginal length of 6 cm or more. The initial total vaginal length (TVL) mean (SD) was 1.81(1.05) and the final TVL mean (SD) was 6.37 (0.94); the difference, analyzed as 95% confidence interval (95% CI) was 4.56 (5.27-3.84) and the effect size (95% CI) was 4.58 (2.88-6.28). Conclusion The 3D printing molds for vaginal dilation were successful in 87.5% of the patients. They did not present any major adverse effects and offered an economical, accessible, and reproducible strategy for the treatment of VA.

Resumo Objetivo O objetivo deste estudo foi avaliar o uso de moldes dilatadores vaginais, confeccionados com impressão tridimensional (3D), para tratamento conservador através da dilatação vaginal em pacientes com agenesia vaginal (AV). Métodos Foram selecionadas 16 pacientes com diagnóstico de AV (síndrome de Mayer-Rokitansky-Küster-Hauser, síndrome de insensibilidade androgênica total e agenesia cervicovaginal), da Universidade Federal de São Paulo. A produção dos dispositivos foi realizada em uma impressora 3D e, como matéria-prima, foi utilizado o filamento polimérico do poliácido lático (PLA). Um tratamento personalizado foi proposto e desenvolvido para cada paciente. Resultados Quatorze pacientes atingiram um comprimento vaginal final (CVF) de 6 cm ou mais. A média inicial do CVF (DP) foi de 1,81 (1,05) e a média final do CVF (DP) 6,37 (0,94); a diferença (IC 95%) foi de 4,56 (5,27-3,84) e o tamanho do efeito (IC 95%) foi de 4,58 (2,88-6,28). Conclusão Os moldes de impressão 3D para dilatação vaginal obtiveram sucesso em 87,5% das pacientes. Como impacto secundário, não apresentaram efeitos adversos importantes e ofereceram uma estratégia econômica, acessível e reprodutível para o tratamento da AV.

Three-dimensional Printer Molds for Vaginal Agenesis: An Individualized Approach as Conservative Treatment.

OBJECTIVE: The aim of this study was to evaluate the use of vaginal molds, made with three-dimensional (3D) printing, for conservative treatment through vaginal dilation in patients with vaginal agenesis (VA). METHODS: A total of 16 patients with a diagnosis of VA (Mayer-Rokitansky-Küster-Hauser syndrome, total androgen insensitivity syndrome, and cervicovaginal agenesis) from the Federal University of São Paulo were selected. Device production was performed in a 3D printer, and the polymeric filament of the lactic polyacid (PLA) was used as raw material. A personalized treatment was proposed and developed for each patient. RESULTS: There were 14 patients who reached a final vaginal length of 6 cm or more. The initial total vaginal length (TVL) mean (SD) was 1.81(1.05) and the final TVL mean (SD) was 6.37 (0.94); the difference, analyzed as 95% confidence interval (95% CI) was 4.56 (5.27-3.84) and the effect size (95% CI) was 4.58 (2.88-6.28). CONCLUSION: The 3D printing molds for vaginal dilation were successful in 87.5% of the patients. They did not present any major adverse effects and offered an economical, accessible, and reproducible strategy for the treatment of VA.

OBJETIVO: O objetivo deste estudo foi avaliar o uso de moldes dilatadores vaginais, confeccionados com impressão tridimensional (3D), para tratamento conservador através da dilatação vaginal em pacientes com agenesia vaginal (AV). MéTODOS: Foram selecionadas 16 pacientes com diagnóstico de AV (síndrome de Mayer-Rokitansky-Küster-Hauser, síndrome de insensibilidade androgênica total e agenesia cervicovaginal), da Universidade Federal de São Paulo. A produção dos dispositivos foi realizada em uma impressora 3D e, como matéria-prima, foi utilizado o filamento polimérico do poliácido lático (PLA). Um tratamento personalizado foi proposto e desenvolvido para cada paciente. RESULTADOS: Quatorze pacientes atingiram um comprimento vaginal final (CVF) de 6 cm ou mais. A média inicial do CVF (DP) foi de 1,81 (1,05) e a média final do CVF (DP) 6,37 (0,94); a diferença (IC 95%) foi de 4,56 (5,27­3,84) e o tamanho do efeito (IC 95%) foi de 4,58 (2,88­6,28). CONCLUSãO: Os moldes de impressão 3D para dilatação vaginal obtiveram sucesso em 87,5% das pacientes. Como impacto secundário, não apresentaram efeitos adversos importantes e ofereceram uma estratégia econômica, acessível e reprodutível para o tratamento da AV.

Metabolomic Profiling of Peripheral Plasma by GC-MS and Correlation With Size of Uterine Leiomyomas.

Background: Uterine leiomyomas are benign monoclonal tumors originating from the myometrium. Little information exists concerning metabolomics and the presence of leiomyomas. Objective: The present study evaluated circulating metabolites in the plasma and their correlation with the presence and size of leiomyomas. Study Design: Cross-sectional observational study, including women divided into 3 groups: 37 with leiomyomas and uterus >500 cm3, 17 with leiomyomas and uterus ≤150 cm3, and 21 leiomyoma-free. Patients underwent peripheral blood collection using untargeted metabolic assessment by gas chromatography coupled to mass spectrometer. Results: There was no statistical difference between patients' anthropometric and demographic features and laboratory tests. Statistical differences in uterus volume (P < 0.0001) were found. Forty-six metabolites were identified (35% amino acids and derivatives, 22% fatty acids, and 18% carbohydrates). Statistically significant metabolic distinction (P < 0.05, false discovery rate< 0.05) was observed for 14 metabolites. Most amino acids (L-isoleucine, L-valine, and pyroglutamic acid) were significantly reduced in plasma levels of patients with large leiomyomas. The only exception was L-glutamine, with a significant increase. Fatty acids (arachidonic acid, alfa-tocopherol, palmitic acid, and stearic acid) were similarly reduced in large leiomyomas patients, except for alpha-linolenic acid, which increased. For carbohydrates (myo-inositol, D-threitol, and D-ribose), there was a decrease in the plasma of patients with leiomyomas. Conclusion: There are different plasma metabolites levels of amino acids, fatty acids, and carbohydrates among patients with leiomyomas, most of them reduced, but some significantly increased in large leiomyomas, compared to leiomyoma-free patients.

Increasing rate of anti-SARS-CoV-2 antibodies between the first and second waves of COVID-19 in São Paulo, Brazil: A cross-sectional blood donors-based study.

BACKGROUND: SARS-CoV-2 infections rapidly spread along with Brazilian territory with heterogeneous transmission and mortality rates, mostly depending on region and period. Investigation of SARS-CoV-2 antibodies is an important tool to understand virus circulation. Given that blood donors are a representative casuistic of a healthy population, the authors evaluated the seroprevalence of IgG and IgM COVID-19 antibodies in 2,806 blood donors from a blood bank located in São Paulo, Brazil. METHODS: Aiming to evaluate viral behavior over time, the authors selected samples from blood donors who donated in June and October 2020, and February 2021. To determine whether socio-demographic features affected the seroprevalence, the authors analyzed samples from three different regions from São Paulo (capital, metropolitan and countryside regions) and evaluated predictors as gender, age, educational level, race, and use of public transportation. RESULTS: As expected, the authors observed that seroprevalence increased over time. Seroprevalence was greater in São Paulo city compared to metropolitan and countryside regions, being smallest in the countryside. Characteristics associated with a lower percentage of antibodies were age above 50 years, higher educational level, self-declared Caucasian, and use of individual transportation. CONCLUSION: In conclusion, blood donors' samples proved to accurately reflect virus circulation in the healthy population.

CO2 Laser and radiofrequency compared to a sham control group in treatment of stress urinary incontinence (LARF study arm 3). A randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: Female stress urinary incontinence (SUI) is a prevalent condition, and conservative treatment options are needed. Were evaluated CO2 laser and radiofrequency as treatment for SUI. METHODS: One hundred thirty-nine women with SUI were eligible and randomized in a three-arm double-blind randomized controlled trial into radiofrequency (RF), laser (LS) and sham control (SCT) groups, with 3-monthly outpatient treatment sessions. One hundred fourteen women were included, 38 in each group, during a 12-month follow-up. The primary outcomes were: subjective improvement of SUI, evaluated on a Likert scale, and objective cure, which was a composite outcome defined according to negative stress tests, voiding diary and pad test. Questionnaires were also applied. The sample size was calculated to provide 80% power to identify a 20% difference between groups, p < 0.05. RESULTS: Subjective improvement and objective cure of SUI were identified respectively in 72.6% and 45.2% in LS and in 61.7% and 44.7% in RF, both significantly higher than the 30.0% and 14.0% in SCT. Considering only mild cases (pad test < 10 g), objective cure was achieved in 66.7% in LS, 63.6% in RF and 22.2% in SCT. Significant reduction in the number of episodes of urinary incontinence was found according to voiding diaries (p = 0.029) and pad weight (p = 0.021). A significant reduction in urgency and urinary loss during sexual intercourse was observed only with LS and RF. Improvement in quality of life was also verified by the I-QoL and ICIQ-SF in favor of the energy-treated groups. CONCLUSIONS: CO2 laser and radiofrequency are outpatient options for SUI treatment, with no major complications. They had similar results and presented better results than in the sham control group.

Urinary incontinence, overactive bladder, and quality of life in women submitted to total hip replacement.

INTRODUCTION AND HYPOTHESIS: Hip osteoarthritis (OA) compromises functioning. Total hip replacement (THR) is the indicated treatment and may improve urinary incontinence (UI) and symptoms of overactive bladder (OAB). OBJECTIVES: Assess UI, OAB symptoms, and quality of life (QoL) impact in preoperative and postoperative periods of women submitted to THR and investigate associated factors. METHODS: A prospective cohort was conducted with 183 women submitted to THR. The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), International Consultation on Incontinence Questionnaire-Overactive Bladder (ICIQ-OAB) and SF-12 questionnaires were administered pre- and 3 and 6 months after surgery. RESULTS: Significant improvements were found in UI and QoL 3- and 6-month postoperatively in the overall sample and in the subgroup with preoperative UI. The multivariate regression revealed that the preoperative ICIQ-SF and ICIQ-OAB final scores were the best predictors of UI 6-month postoperatively. The factors the best predicted the occurrence of UI 6-month following THR were the preoperative ICIQ-OAB scores and preoperative UI. Each unit of increase in the ICIQ-OAB increases the chances of UI by 26.9% and preoperative UI increases the chances of postoperative UI by 18.7-fold. A weak but significant negative correlation was found between the ICIQ-SF score and the SF-12 score. CONCLUSION: Significant improvements in UI, OAB and QoL were found at 3- and 6-month postoperatively. Preoperative ICIQ-SF and ICIQ-OAB final scores were the best predictors of UI at 6 months after surgery. We found significant association between urinary symptoms and THR, but this association is partially explained by current literature.

Fecal incontinence: incidence and risk factors from the SABE (Health, Wellbeing and Aging) study.

INTRODUCTION AND HYPOTHESIS: This study aimed to estimate the incidence of fecal incontinence (FI) and identify risk factors in a cohort of older individuals. METHODS: In 2006, individuals aged ≥ 60 years were selected from the SABE study. The dependent variable was FI in 2010. FI was assessed using the question: "In the last 12 months, have you ever lost control of bowel movements or stools?" Incidence was measured in units of per 1000 person-years. Multivariate analysis was used to assess risk factors for FI. RESULTS: This study was the first to examine the incidence of FI in older Brazilian individuals. In total, 1413 individuals were included; mean age was 74.5 years, and 864 (61.8%) participants were women. FI prevalence rates were 4.7% for men and 7.3% for women. Incidence rate of FI was 16.3 and 22.2 per 1000 person-years for men and women, respectively. The risk of FI was greater among women aged ≥ 75 years, with severe symptoms of depression, cancer (other than skin) and chronic obstructive pulmonary disease (COPD). In men, the risk of FI was greater among those with poor literacy (up to 3 years of schooling), an Instrumental Activities of Daily Living (IADL) category of 1-4 and those who self-reported "bad/very bad" health status. CONCLUSIONS: The FI incidence rate was high. The identified risk factors were age ≥ 75 years, with severe symptoms of depression, cancer and COPD (women); having up to 8 years of schooling; IADL category of 1-4 and self-reported health status (men).

Treatment for vaginal agenesis: A prospective and comparative study between vaginal dilation and surgical neovaginoplasty.

OBJECTIVE: To compare, in terms of anatomical, functional, and sexual aspects, two types of treatment for women with vaginal agenesis: progressive dilation or surgical neovaginoplasty. METHODS: Women with vaginal agenesis underwent either dilation treatment using the Frank method or surgical treatment using the modified Abbé-McIndoe technique with oxidized cellulose. Patients were evaluated 3-6 months after treatment for a follow-up including medical history, physical examination, general satisfaction, clinical aspect of the vagina, Female Sexual Function Index, and three-dimensional pelvic floor ultrasound. RESULTS: In total, 20 women with vaginal agenesis were included in the present study; nine in the dilation group and 11 in the surgical group. A comparison between the groups (vaginal dilation and surgical neovaginoplasty) showed efficacy in neovagina formation after both treatments, with a statistically significant difference between the pre- and post-treatment periods (P value pre- × post-dilation group <0.0001 and P value pre- × post-surgical group <0.0001). There were no statistical differences in total vaginal length measurements (P value post-dilation × post-surgical = 0.09) or Female Sexual Function Index scores (P = 0.72) after both treatments. CONCLUSION: Both treatments had satisfactory efficacy and positive outcomes for patients with vaginal agenesis concerning anatomical, functional, and sexual aspects, with minimum complications in the surgical group. Dilation treatment can remain the first-line therapy.

Pooled incidence of continuation and pregnancy rates of four contraceptive methods in young women: a meta-analysis.

BACKGROUND: Continuation rates of contraceptive methods in young women vary among studies, and there is scarce data regarding the pregnancy rate in this population. METHODS: Four independently systematic searches were performed in PUBMED, EMBASE, LILACS, and Cochrane databases from inception until January 2021 for oral contraceptive pill (OCP), copper IUD, levonorgestrel intrauterine system (LNG-IUS), and subdermal implant. Inclusion criteria were observational or RCT studies that reported continuation for at least 12 months and/or pregnancy rate of these contraceptives methods in girls aged 22 years old or younger. Two authors extracted data from the study design and the outcomes. Pooled proportions of each method were applied using the inverse variance in all calculations with LOGIT transformation, using the random-effects model. Cochrane collaboration tool and New Castle-Ottawa were used to assess the quality and bias of all included studies. GRADE criteria evaluated the quality of evidence. RESULTS: Continuation rate for OCP was 51% (95%CI 34%-68%), while for cooper IUD was 77% (95%CI 74%-80%), LNG-IUS 84% (95%CI 80%-87%), and implant 85% (95%CI 81%-88%). The pooled estimated pregnancy rate for OCP was 11% (95%CI 6%-20%), while for cooper IUD was 5% (95%CI 3%-7%), LNG-IUS 1.6% (95%CI 1.2%-2.3%), and implant 1.8% (95%CI 0.4%-8.4%). CONCLUSION: Long-acting contraceptive methods presented higher continuation rates and lower pregnancy rates when compared to OCPs.

A Cost Effectiveness Model of Long-Acting Reversible Contraceptive Methods in the Brazilian National Health System.

INTRODUCTION: The use of long-acting reversible contraceptives is low among adolescents owing to the high up-front cost. In this study, a 5-year cost-effectiveness model and budget impact analysis were used to compare the use of long-acting reversible contraceptives with the use of combined oral contraceptives among Brazilian adolescents. METHODS: A Markov model was developed to mirror the clinical and economic effects of long-acting reversible contraceptives among sexually active Brazilian adolescents in the public health system for a 5-year duration, starting from 2018. The costs were expressed in U.S.$, and a 5% discount rate was applied for both costs and benefits. Model inputs included costs of the contraceptive methods, contraceptive discontinuation and adherence rates, abortion, and birth costs associated with unintended pregnancies. The model outcomes were avoided pregnancies, abortions, and births. Univariate and probabilistic sensitivity analyses were conducted. RESULTS: Copper intrauterine device use was dominant 100% of the time for all outcomes, and a budget impact analysis revealed a cost savings of $422,431,269.10 in the 5-year period. Levonorgestrel intrauterine system and subdermal implant use were cost effective for all outcomes. The budget impact analyses revealed costs of $65,645,417.54 for levonorgestrel intrauterine system and $302,852,972.12 for subdermal implant use during the 5-year study period. CONCLUSIONS: According to this Brazilian model, copper intrauterine device use is dominant, and levonorgestrel intrauterine systems and subdermal implants are more cost effective than combined oral contraceptives.

Increasing rate of anti-SARS-CoV-2 antibodies between the first and second waves of COVID-19 in Sao Paulo, Brazil: A cross-sectional blood donors-based study

ABSTRACT Background: SARS-CoV-2 infections rapidly spread along with Brazilian territory with heterogeneous transmission and mortality rates, mostly depending on region and period. Investigation of SARS-CoV-2 antibodies is an important tool to understand virus circulation. Given that blood donors are a representative casuistic of a healthy population, the authors evaluated the seroprevalence of IgG and IgM COVID-19 antibodies in 2,806 blood donors from a blood bank located in São Paulo, Brazil. Methods: Aiming to evaluate viral behavior over time, the authors selected samples from blood donors who donated in June and October 2020, and February 2021. To determine whether socio-demographic features affected the seroprevalence, the authors analyzed samples from three different regions from São Paulo (capital, metropolitan and countryside regions) and evaluated predictors as gender, age, educational level, race, and use of public transportation. Results: As expected, the authors observed that seroprevalence increased over time. Seroprevalence was greater in São Paulo city compared to metropolitan and countryside regions, being smallest in the countryside. Characteristics associated with a lower percentage of antibodies were age above 50 years, higher educational level, self-declared Caucasian, and use of individual transportation. Conclusion: In conclusion, blood donors' samples proved to accurately reflect virus circulation in the healthy population.

Prevalence of Urinary Incontinence in CrossFit Practitioners before and during the COVID-19 Quarantine and its Relationship with Training Level: An Observational Study.

OBJECTIVE: To compare the prevalence of urinary incontinence (UI) before and during the COVID-19 quarantine in CrossFit women and their relationship with training level. METHODS: A cross-sectional study was performed among 197 women practicing CrossFit. The inclusion criteria were nulliparous women, between 18 and 45 years old, who had trained, before quarantine, in accredited gyms. The exclusion criteria were not following the COVID-19 prevention protocols and having UI on other occasions than just sport. An online questionnaire was emailed containing questions about frequency, duration, and intensity of training and data related to the COVID-19 pandemic. The participants were invited to answer whether they were infected with COVID-19 and what treatment/recommendation they have followed. Whether UI stopped among participants, they were asked about the possible reasons why this happened. The training intensity was categorized as "the same," "decreased" or "increased." RESULTS: The mean age of the participants was 32 years old and most (98.5%) could practice CrossFit during the pandemic. There was a decrease in training intensity in 64% of the respondents. Exercises with their own body weight, such as air squat (98.2%), were the most performed. Urinary incontinence was reported by 32% of the participants before the COVID-19 pandemic, and by only 14% of them during the pandemic (odds ratio [OR] = 0.32 [0.19-0.53]; p < 0.01; univariate analysis). Practitioners reported that the reason possibly related to UI improvement was the reduction of training intensity and not performing doubleunder exercise. CONCLUSION: The reduction in the intensity of CrossFit training during the COVID-19 quarantine decreased the prevalence of UI among female athletes.

OBJETIVO: Comparar a prevalência de incontinência urinária (IU) no CrossFit, antes e durante a quarentena por COVID-19, e sua relação com a intensidade do treinamento. MéTODOS: Estudo observacional com 197 atletas de CrossFit. Os critérios de inclusão foram: nulíparas, 18 a 45 anos, treinando antes da quarentena em academias credenciadas. Os critérios de exclusão foram: não seguir os protocolos de prevenção da COVID-19 e ter IU em outras ocasiões que não apenas no esporte. Utilizou-se um questionário online com perguntas sobre frequência, duração e intensidade do treinamento e dados relacionados à pandemia, além de caso tivessem tido infecção pelo SARS-COV2, qual tratamento/recomendação seguiram. Caso a IU tenha parado entre as participantes, elas foram perguntadas quanto quais as possíveis razões pelas quais isso aconteceu. A intensidade do treinamento foi categorizada como "igual," "diminuída" ou "aumentada ". RESULTADOS: A média de idade foi de 32 anos e a maioria (98,5%) conseguiu praticar CrossFit durante a pandemia. Houve uma diminuição na intensidade do treinamento em 64% das entrevistadas. Exercícios com o próprio peso corporal, como agachamento no ar (98,2%), foram os mais realizados. Incontinência urinária foi relatada por 32% das participantes antes da pandemia e por apenas 14% durante a pandemia (odds ratio [OR] = 0,32 [0,19­0,53]; p < 0,01). As atletas relataram que o motivo possivelmente relacionado à melhora da IU foi a redução da intensidade do treinamento e não realizar o exercício doubleunder. CONCLUSãO: A redução da intensidade do treinamento de CrossFit durante a quarentena por COVID-19 diminuiu a prevalência de IU entre as atletas.

Prevalence of Urinary Incontinence in CrossFit Practitioners before and during the COVID-19 Quarantine and its Relationship with Training Level: An Observational Study / Prevalência da incontinência urinária em praticantes de CrossFit antes e durante a quarentena pelo COVID-19 e sua relação com o nível de treinamento: Um estudo observacional

Abstract Objective To compare the prevalence of urinary incontinence (UI) before and during the COVID-19 quarantine in CrossFit women and their relationship with training level. Methods A cross-sectional study was performed among 197 women practicing CrossFit. The inclusion criteria were nulliparous women, between 18 and 45 years old, who had trained, before quarantine, in accredited gyms. The exclusion criteria were not following the COVID-19 prevention protocols and having UI on other occasions than just sport. An online questionnaire was emailed containing questions about frequency, duration, and intensity of training and data related to the COVID-19 pandemic. The participants were invited to answer whether they were infected with COVID-19 and what treatment/recommendation they have followed. Whether UI stopped among participants, they were asked about the possible reasons why this happened. The training intensity was categorized as "the same," "decreased" or "increased." Results The mean age of the participants was 32 years old and most (98.5%) could practice CrossFit during the pandemic. There was a decrease in training intensity in 64% of the respondents. Exercises with their own body weight, such as air squat (98.2%), were the most performed. Urinary incontinence was reported by 32% of the participants before the COVID-19 pandemic, and by only 14% of them during the pandemic (odds ratio [OR]=0.32 [0.19-0.53]; p<0.01; univariate analysis). Practitioners reported that the reason possibly related to UI improvement was the reduction of training intensity and not performing doubleunder exercise. Conclusion The reduction in the intensity of CrossFit training during the COVID-19 quarantine decreased the prevalence of UI among female athletes.

Resumo Objetivo Comparar a prevalência de incontinência urinária (IU) no CrossFit, antes e durante a quarentena por COVID-19, e sua relação com a intensidade do treinamento. Métodos Estudo observacional com 197 atletas de CrossFit. Os critérios de inclusão foram: nulíparas, 18 a 45 anos, treinando antes da quarentena em academias credenciadas. Os critérios de exclusão foram: não seguir os protocolos de prevenção da COVID-19 e ter IU em outras ocasiões que não apenas no esporte. Utilizou-se um questionário online com perguntas sobre frequência, duração e intensidade do treinamento e dados relacionados à pandemia, além de caso tivessem tido infecção pelo SARS-COV2, qual tratamento/recomendação seguiram. Caso a IU tenha parado entre as participantes, elas foram perguntadas quanto quais as possíveis razões pelas quais isso aconteceu. A intensidade do treinamento foi categorizada como "igual," "diminuída" ou "aumentada ". Resultados A média de idade foi de 32 anos e a maioria (98,5%) conseguiu praticar CrossFit durante a pandemia. Houve uma diminuição na intensidade do treinamento em 64% das entrevistadas. Exercícios com o próprio peso corporal, como agachamento no ar (98,2%), foram os mais realizados. Incontinência urinária foi relatada por 32% das participantes antes da pandemia e por apenas 14% durante a pandemia (odds ratio [OR]=0,32 [0,19-0,53]; p<0,01). As atletas relataram que o motivo possivelmente relacionado à melhora da IU foi a redução da intensidade do treinamento e não realizar o exercício doubleunder. Conclusão A redução da intensidade do treinamento de CrossFit durante a quarentena por COVID-19 diminuiu a prevalência de IU entre as atletas.

Willingness to pay for short- and long-acting contraceptives among female adolescents and their parents in Brazil:a pilot study.

OBJECTIVE: To evaluate willingness to pay for short- and long-acting reversible contraceptive methods among female Brazilian adolescents and their parents, as well as their perspective on using such methods. METHODS: This is a cross-sectional study of female adolescents aged 13 to 19 years and their parents. We surveyed to estimate their willingness to pay for contraceptive methods. The values are expressed as mean±standard deviation in Brazilian reals (R$). Spearman correlation was employed for socioeconomic status of parents, age of adolescents and their standpoints. The methods types and adolescent and parent perspectives were analyzed by the test χ2. To determine an agreement between pairs and their willingness to pay, we used the Bland-Altman plot. RESULTS: A total of 165 surveys were collected. Short-acting method was significantly more acceptable to pay than the long-action method, by both parents and their daughters. Parents and their daughters are willing to pay out-of-pocket R$ 52,25±22,48 and R$ 51,63±21,24 for short-acting reversible contraception method, and R$ 176,83±130,34 and R$ 174,83±143,64, for long-acting method, respectively. Bland-Altman analysis indicated an agreement on both perspectives and the price they are willing to pay for each contraceptive method. CONCLUSION: Parents and adolescent daughters are more willing to pay for short-acting methods. We showed an agreement between the parent and the daughter for the values paid for each method.

A Single Dose of a Hybrid hAdV5-Based Anti-COVID-19 Vaccine Induces a Long-Lasting Immune Response and Broad Coverage against VOC.

Most approved vaccines against COVID-19 have to be administered in a prime/boost regimen. We engineered a novel vaccine based on a chimeric human adenovirus 5 (hAdV5) vector. The vaccine (named CoroVaxG.3) is based on three pillars: (i) high expression of Spike to enhance its immunodominance by using a potent promoter and an mRNA stabilizer; (ii) enhanced infection of muscle and dendritic cells by replacing the fiber knob domain of hAdV5 by hAdV3; (iii) use of Spike stabilized in a prefusion conformation. The transduction with CoroVaxG.3-expressing Spike (D614G) dramatically enhanced the Spike expression in human muscle cells, monocytes and dendritic cells compared to CoroVaxG.5 that expressed the native fiber knob domain. A single dose of CoroVaxG.3 induced a potent humoral immunity with a balanced Th1/Th2 ratio and potent T-cell immunity, both lasting for at least 5 months. Sera from CoroVaxG.3-vaccinated mice was able to neutralize pseudoviruses expressing B.1 (wild type D614G), B.1.117 (alpha), P.1 (gamma) and B.1.617.2 (delta) Spikes, as well as an authentic P.1 SARS-CoV-2 isolate. Neutralizing antibodies did not wane even after 5 months, making this kind of vaccine a likely candidate to enter clinical trials.

Antibody indexes in COVID-19 convalescent plasma donors: Unanswered questions.

OBJECTIVE: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is characterized by high contagiousness, as well as variable clinical manifestations and immune responses. The antibody response to SARS-CoV-2 is directly related to viral clearance and the antibodies' ability to neutralize the virus and confer long-term immunity. Nevertheless, the response can also be associated with disease severity and evolution. This study correlated the clinical characteristics of convalescent COVID-19 patients with immunoglobulin A (IgA) and IgG anti-SARS-CoV-2 antibodies. METHODS: This study included 51 COVID-19 health care professionals who were candidates for convalescent plasma donation from April to June 2020. The subjects had symptomatic COVID-19 with a polymerase chain reaction-confirmed diagnosis. We measured anti-SARS-CoV-2 IgA and IgG antibodies after symptom recovery, and the subjects were classified as having mild, moderate, or severe symptoms. RESULTS: Anti-SARS-CoV-2 antibodies were positive in most patients (90.2%). The antibody indexes for IgA and IgG did not differ significantly between patients presenting with mild or moderate symptoms. However, they were significantly higher in patients with severe symptoms. CONCLUSIONS: Our study showed an association between higher antibody indexes and severe COVID-19 cases, and several hypotheses regarding the association of the antibody dynamics and severity of the disease in SARS-CoV-2 infection have been raised, although many questions remain unanswered.