Pelvic floor muscle training vs radiofrequency for women with vaginal laxity: randomized clinical trial.

BACKGROUND: Vaginal laxity (VL) is a complaint of excessive vaginal looseness with a prevalence ranging from 24% to 38% across studies. AIM: The study sought to compare the effect of radiofrequency (RF) and pelvic floor muscle training (PFMT) on the treatment of women with VL. METHODS: From February 2020 to December 2021, a prospective, parallel, noninferiority, randomized clinical trial was carried out in women ≥18 years of age and complaining of VL in a tertiary hospital. Two groups (RF and PFMT) were evaluated at the beginning of the study and 30 days and 6 months postintervention. A total of 42 participants per arm was sufficient to demonstrate a difference in sexual function on the Female Sexual Function Index at 90% power, 1-sided type 1 error of 0.025 with a noninferiority margin of 4 on the FSFI total score. Analysis was intention-to-treat and per-protocol based. OUTCOMES: The primary endpoint was the change of FSFI score after treatment, and the secondary outcomes were improvement in symptoms of VL and changes in questionnaire scores of sexual distress, vaginal symptoms, and urinary incontinence, in the quantification of pelvic organ prolapse, and pelvic floor muscle (PFM) contraction. RESULTS: Of 167 participants recruited, 87 were included (RF: n = 42; PFMT: n = 45). All questionnaires improved (P < .05) their total scores and subscales in both groups and during the follow-ups. After 30 days of treatment, RF was noninferior to PFMT to improving FSFI total score (mean difference -0.08 [95% confidence interval, -2.58 to 2.42]) in the per-protocol analysis (mean difference -0.46 [95% confidence interval, -2.92 to 1.99]) and in the intention-to-treat analysis; however, this result was not maintained after 6 months of treatment. PFM contraction improved significantly in both groups (RF: P = .006, 30 days; P = .049, 6 months; PFMT: P < .001, 30 days and 6 months), with better results in the PFMT group. CLINICAL IMPLICATIONS: Sexual, vaginal, and urinary symptoms were improved after 30 days and 6 months of treatment with RF and PFMT; however, better results were observed in the PFMT group after 6 months. STRENGTHS & LIMITATIONS: The present randomized clinical trial used several validated questionnaires evaluating quality of life, sexual function and urinary symptoms, in addition to assessing PFM contraction and classifying the quantification of pelvic organ prolapse aiming at anatomical changes in two follow-up periods. The limitations were the lack of a sham-controlled group (third arm) and the difficulty of blinding researchers to assess treatments due to the COVID-19 pandemic. CONCLUSION: After 30 days and 6 months of treatment, sexual, vaginal, and urinary symptoms improved with RF and PFMT; however, better results were observed in the PFMT group after 6 months. RF was noninferior to PFMT in improving FSFI total score after 30 days; however, this result was not maintained after 6 months of treatment.

Measurement of the vaginal wall thickness by transabdominal and transvaginal ultrasound of women with vaginal laxity: a cross-sectional study.

INTRODUCTION AND HYPOTHESIS: An objective diagnostic method to understand vaginal laxity (VL) is still missing. The aim of our study is to determine whether vaginal wall thickness (VWT) measured by ultrasound may differ according to the abdominal or vaginal techniques and to assess whether clinical variables are associated with vaginal measurements of women with VL. METHODS: A cross-sectional study conducted at a tertiary hospital included 82 women aged ≥ 18 years with VL complaints assessed by the Vaginal Laxity Questionnaire. Women who reported severe comorbidities or vulvovaginal disorders, previous treatment for VL, and use of vaginal estrogen in the last 6 months were excluded. Participants reporting VL underwent transabdominal (TAUS) and transvaginal ultrasound (TVUS) and physical examination and answered validated questionnaires. Descriptive data were given as mean and standard deviation, median (range), and absolute and relative frequency. The significance level adopted for this study was 5%. Sample size calculation was not performed for the present study. RESULTS: Mean age was 41.20 ± 8.64 years, and most participants were multiparous, with previous vaginal delivery and having vaginal intercourse. A statistically significant difference (up to 3 mm) between TAUS and TVUS measurements of the VWT was found in the proximal, middle-third, and distal compartments. A significant correlation was found between VWT and TAUS or TVUS in the mid-third and distal compartments. CONCLUSION: A significant correlation was found between the VWT measurements in TVUS and TAUS. Our findings might give the health professional more possibilities for investigating VWT according to patient characteristics.

Effect of radiofrequency and pelvic floor muscle training in the treatment of women with vaginal laxity: A study protocol.

BACKGROUND: Vaginal laxity is an underreported condition that negatively affects women's sexual function and their relationships. Evidence-based studies are needed to better understand this complaint and to discuss its treatment options. Thus, we present a study protocol to compare the effect of radiofrequency and pelvic floor muscle training in the treatment of women with complaints of vaginal laxity. METHODS/DESIGN: This is a prospective, parallel-group, two-arm, randomized clinical trial (Registry: RBR-2zdvfp-REBEC). Participants will be randomly assigned to one of the two groups of intervention (Radiofrequency or Pelvic Floor Muscle Training). The study will be performed in the Urogynecology outpatient clinic and in the physiotherapy outpatient clinic at the State University of Campinas-UNICAMP and will include women aged ≥ 18 years and with self-reported complaints of vaginal laxity. Participants will be assessed at baseline (pre-intervention period) and will be followed up in two periods: first follow-up (30 days after intervention) and second follow-up (six months after intervention). EXPECTED RESULTS: The results of this randomized clinical trial will have a positive impact on the participants' quality of life, as well as add value to the development of treatment options for women with complaints of vaginal laxity. TRIAL REGISTRATION: Registry: RBR-2zdvfp-Registro Brasileiro de Ensaios Clínicos-REBEC (19/02/2020).

A randomized controlled trial on the use of pessary plus progesterone to prevent preterm birth in women with short cervical length (P5 trial).

BACKGROUND: Preterm birth is the leading cause of mortality and disability in newborn and infants. Having a short cervix increases the risk of preterm birth, which can be accessed by a transvaginal ultrasound scan during the second trimester. In women with a short cervix, vaginal progesterone and pessary can both reduce this risk, which progesterone more established than cervical pessary. The aim of this study is to compare the use of vaginal progesterone alone versus the association of progesterone plus pessary to prevent preterm birth in women with a short cervix. METHODS: This is a pragmatic open-label randomized controlled trial that will take place in 17 health facilities in Brazil. Pregnant women will be screened for a short cervix with a transvaginal ultrasound between 18 0/7 until 22 6/7 weeks of gestational age. Women with a cervical length below or equal to 30 mm will be randomized to the combination of progesterone (200 mg) and pessary or progesterone (200 mg) alone until 36 + 0 weeks. The primary outcome will be a composite of neonatal adverse events, to be collected at 10 weeks after birth. The analysis will be by intention to treat. The sample size is 936 women, and a prespecified subgroup analysis is planned for cervical length (= < or > 25 mm). Categorical variables will be expressed as a percentage and continuous variables as mean with standard deviation. Time to delivery will be assessed with Kaplan-Meier analysis and Cox proportional hazard analysis. DISCUSSION: In clinical practice, the combination of progesterone and pessary is common however, few studies have studied this association. The combination of treatment might act in both the biochemical and mechanical routes related to the onset of preterm birth. TRIAL REGISTRATION: Brazilian Clinical Trial Registry (ReBec) RBR-3t8prz, UTN: U1111-1164-2636, 2014/11/18.

Micromass cultures are effective for differentiation of human amniotic fluid stem cells into chondrocytes.

OBJECTIVES: Articular cartilage is vulnerable to injuries and undergoes an irreversible degenerative process. The use of amniotic fluid mesenchymal stromal stem cells for the reconstruction of articular cartilage is a promising therapeutic alternative. The aim of this study was to investigate the chondrogenic potential of amniotic fluid mesenchymal stromal stem cells from human amniotic fluid from second trimester pregnant women in a micromass system (high-density cell culture) with TGF-ß3 for 21 days. METHODS: Micromass was performed using amniotic fluid mesenchymal stromal stem cells previously cultured in a monolayer. Chondrocytes from adult human normal cartilage were used as controls. After 21 days, chondrogenic potential was determined by measuring the expression of genes, such as SOX-9, type II collagen and aggrecan, in newly differentiated cells by real-time PCR (qRT-PCR). The production of type II collagen protein was observed by western blotting. Immunohistochemistry analysis was also performed to detect collagen type II and aggrecan. This study was approved by the local ethics committee. RESULTS: SOX-9, aggrecan and type II collagen were expressed in newly differentiated chondrocytes. The expression of SOX-9 was significantly higher in newly differentiated chondrocytes than in adult cartilage. Collagen type II protein was also detected. CONCLUSION: We demonstrate that stem cells from human amniotic fluid are a suitable source for chondrogenesis when cultured in a micromass system. amniotic fluid mesenchymal stromal stem cells are an extremely viable source for clinical applications, and our results suggest the possibility of using human amniotic fluid as a source of mesenchymal stem cells.

Micromass cultures are effective for differentiation of human amniotic fluid stem cells into chondrocytes

OBJECTIVES: Articular cartilage is vulnerable to injuries and undergoes an irreversible degenerative process. The use of amniotic fluid mesenchymal stromal stem cells for the reconstruction of articular cartilage is a promising therapeutic alternative. The aim of this study was to investigate the chondrogenic potential of amniotic fluid mesenchymal stromal stem cells from human amniotic fluid from second trimester pregnant women in a micromass system (high-density cell culture) with TGF-β3 for 21 days. METHODS: Micromass was performed using amniotic fluid mesenchymal stromal stem cells previously cultured in a monolayer. Chondrocytes from adult human normal cartilage were used as controls. After 21 days, chondrogenic potential was determined by measuring the expression of genes, such as SOX-9, type II collagen and aggrecan, in newly differentiated cells by real-time PCR (qRT-PCR). The production of type II collagen protein was observed by western blotting. Immunohistochemistry analysis was also performed to detect collagen type II and aggrecan. This study was approved by the local ethics committee. RESULTS: SOX-9, aggrecan and type II collagen were expressed in newly differentiated chondrocytes. The expression of SOX-9 was significantly higher in newly differentiated chondrocytes than in adult cartilage. Collagen type II protein was also detected. CONCLUSION: We demonstrate that stem cells from human amniotic fluid are a suitable source for chondrogenesis when cultured in a micromass system. amniotic fluid mesenchymal stromal stem cells are an extremely viable source for clinical applications, and our results suggest the possibility of using human amniotic fluid as a source of mesenchymal stem cells.

Reference Ranges for Ultrasonographic Measurements of the Uterine Cervix in Low-Risk Pregnant Women / Valores de referência das medidas ultrassonográficas do colo uterino em gestantes de baixo risco

Abstract Objective To define transvaginal ultrasound reference ranges for uterine cervix measurements according to gestational age (GA) in low-risk pregnancies. Methods Cohort of low-risk pregnantwomen undergoing transvaginal ultrasound exams every 4 weeks, comprisingmeasurements of the cervical length and volume, the transverse and anteroposterior diameters of the cervix, and distance fromthe entrance of the uterine artery into the cervix until the internal os. The inter- and intraobserver variabilities were assessed with the linear correlation coefficient and the Student t-test. Within each period of GA, 2.5, 10, 50, 90 and 97.5 percentiles were estimated, and the variation by GA was assessed with analysis of variance for dependent samples. Mean values and Student t-test were used to compare the values stratified by control variables. Results After confirming the high reproducibility of the method, 172 women followed in this cohort presented a reduction in cervical length, with an increase in volume and in the anteroposterior and transverse diameters during pregnancy. Smaller cervical lengths were associated with younger age, lower parity, and absence of previous cesarean section (C-section). Conclusion In the studied population, we observed cervical length shortening throughout pregnancy, suggesting a physiological reduction mainly in the vaginal portion of the cervix. In order to better predict pretermbirth, cervical insufficiency and premature rupture of membranes, reference curves and specific cut-off values need to be validated.

Resumo Objetivo Elaborar curvas de referências de medidas ultrassonográficas de colo uterino por idade gestacional (IG) em gestações de baixo risco. Métodos Coorte de gestantes de baixo risco, submetidas a ultrassom transvaginal repetido a cada 4 semanas, com medida do comprimento, dos diâmetros anteroposterior e transverso, da distância entre a entrada da artéria uterina no colo e o orifício interno, e do volume do colo. Foi avaliada a variabilidade inter e intraobservador entre as medidas com o coeficiente de correlação linear e teste t de Student. Para cada faixa de IG, estimaram-se os percentis 2,5, 10, 50, 90 e 97,5 dos valores das medidas, com a variação por IG avaliada por análise de variância para amostras dependentes. As comparações dos valores por variáveis de controle foram feitas por meio dos cálculos de médias e teste t de Student. Resultados Assegurada a alta reprodutibilidade do método, as 172 mulheres acompanhadas na coorte apresentaram redução das medidas de comprimento de colo com o decorrer da gestação, com aumento de volume e dos diâmetros anteroposterior e transverso. O menor comprimento cervical foi associado à menor idade materna, menor paridade, e ausência de cesárea prévia. Conclusão Na população estudada foi observada redução no comprimento cervical com o decorrer da gestação, sugerindo encurtamento fisiológico principalmente à custa da porção vaginal do colo. Há a necessidade de validar tais curvas de referência e pontos de corte específicos para uma melhor predição de risco de parto pré-termo, insuficiência cervical, e amniorrexe prematura.

Reference Ranges for Ultrasonographic Measurements of the Uterine Cervix in Low-Risk Pregnant Women.

Objective To define transvaginal ultrasound reference ranges for uterine cervix measurements according to gestational age (GA) in low-risk pregnancies. Methods Cohort of low-risk pregnant women undergoing transvaginal ultrasound exams every 4 weeks, comprising measurements of the cervical length and volume, the transverse and anteroposterior diameters of the cervix, and distance from the entrance of the uterine artery into the cervix until the internal os. The inter- and intraobserver variabilities were assessed with the linear correlation coefficient and the Student t-test. Within each period of GA, 2.5, 10, 50, 90 and 97.5 percentiles were estimated, and the variation by GA was assessed with analysis of variance for dependent samples. Mean values and Student t-test were used to compare the values stratified by control variables. Results After confirming the high reproducibility of the method, 172 women followed in this cohort presented a reduction in cervical length, with an increase in volume and in the anteroposterior and transverse diameters during pregnancy. Smaller cervical lengths were associated with younger age, lower parity, and absence of previous cesarean section (C-section). Conclusion In the studied population, we observed cervical length shortening throughout pregnancy, suggesting a physiological reduction mainly in the vaginal portion of the cervix. In order to better predict preterm birth, cervical insufficiency and premature rupture of membranes, reference curves and specific cut-off values need to be validated.

Objetivo Elaborar curvas de referências de medidas ultrassonográficas de colo uterino por idade gestacional (IG) em gestações de baixo risco. Métodos Coorte de gestantes de baixo risco, submetidas a ultrassom transvaginal repetido a cada 4 semanas, com medida do comprimento, dos diâmetros antero-posterior e transverso, da distância entre a entrada da artéria uterina no colo e o orifício interno, e do volume do colo. Foi avaliada a variabilidade inter e intraobservador entre as medidas com o coeficiente de correlação linear e teste t de Student. Para cada faixa de IG, estimaram-se os percentis 2,5, 10, 50, 90 e 97,5 dos valores das medidas, com a variação por IG avaliada por análise de variância para amostras dependentes. As comparações dos valores por variáveis de controle foram feitas por meio dos cálculos de médias e teste t de Student. Resultados Assegurada a alta reprodutibilidade do método, as 172 mulheres acompanhadas na coorte apresentaram redução das medidas de comprimento de colo com o decorrer da gestação, com aumento de volume e dos diâmetros anteroposterior e transverso. O menor comprimento cervical foi associado à menor idade materna, menor paridade, e ausência de cesárea prévia. Conclusão Na população estudada foi observada redução no comprimento cervical com o decorrer da gestação, sugerindo encurtamento fisiológico principalmente à custa da porção vaginal do colo. Há a necessidade de validar tais curvas de referência e pontos de corte específicos para uma melhor predição de risco de parto pré-termo, insuficiência cervical, e amniorrexe prematura.

Congenital hydrocephalus: gestational and neonatal outcomes.

PURPOSE: To evaluate gestational and neonatal outcomes in pregnancies complicated by fetal hydrocephalus. METHODS: Retrospective analysis of 287 cases of fetal hydrocephalus followed at the Fetal Medicine Unit of the University of Campinas in the period of 1996 to 2006. RESULTS: Mean maternal age was 25 years, mean gestational age at diagnosis was 27 weeks. There were 50 cases of isolated ventriculomegaly, 95 cases of Chiari II malformation and 142 cases of ventriculomegaly associated with other malformations. Preterm delivery and vaginal delivery were more frequent in the group of ventriculomegaly associated with other malformations. Cardiac, skeletal and renal malformations were the most common associated malformations. Cesarean section was common (95%) in the Chiari II group. Fetal and neonatal death occurred more frequently (29 and 68%, respectively) in the group of ventriculomegaly associated with other malformations. Chromosomal anomalies were present in 15% of 165 investigated cases. CONCLUSIONS: Fetal and neonatal prognosis and outcome are associated with the presence of associated anomalies and aneuploidy.

Desempenho da ultra-sonografia na detecção das metástases em linfonodos axilares em mulheres com câncer de mama / Performance of ultrasound in the detection of axillary lymph node metastases in breast cancer patients

OBJETIVOS: avaliar o desempenho de diversas características ultra-sonográficas morfológicas (12) e doplervelocimétricas (7), para detecção de metástases linfonodais em mulheres com câncer de mama. MÉTODOS: foram incluídas 179 mulheres (181 axilas), entre janeiro e dezembro de 2004. Os exames ultra-sonográficos foram realizados com transdutor linear em tempo real (Toshiba-Power Vision-6000 (modelo SSA-370A)). Para o estudo de parâmetros morfológicos foram utilizadas freqüências entre 7,5 e 12 MHz. Para os parâmetros Doppler foi utilizada freqüência de 5 MHz. Subsequentemente, as pacientes foram submetidas a axilectomia dos níveis I, II e III (158) ou à técnica do linfonodo sentinela (23). Foram calculadas a sensibilidade, a especificidade e os valores preditivos positivo e negativo para cada parâmetro. Para a associação de parâmetros foi utilizada a árvore de decisão. Foram estabelecidos os valores de corte para as variáveis contínuas por meio da curva ROC. RESULTADOS: ao exame ultra-sonográfico foi identificado pelo menos um linfonodo axilar em 173 (96 por cento) exames. O exame histológico detectou metástase linfonodal em 87 mulheres (48 por cento). As melhores sensibilidades dos critérios morfológicos foram encontradas com o volume (62 por cento), diâmetro ântero-posterior (62 por cento) e local do centro ecogênico (56 por cento). Embora a especificidade da invasão da gordura adjacente (100 por cento), regularidade das margens (92 por cento) e da ecotextura do parênquima (99 por cento) tenham sido elevadas, a sensibilidade destes parâmetros foi muito baixa. Nenhum critério dopplervelocimétrico alcançou 50 por cento de sensibilidade. A árvore de decisão selecionou a localização do centro ecogênico, a ecotextura do parênquima e a regularidade das margens como melhor associação de parâmetros. CONCLUSAO: o estadiamento dos linfonodos axilares por método não invasivo ainda é um objetivo não alcançado no tratamento das pacientes com câncer de mama

Diagnóstico do oligoâmnio pela ultra-sonografia: uso de diferentes medidas do maior bolsão comparadas ao ILA / Diagnostic capacity of oligohydramnios by ultrasound using different measures os the maximum pool depth of amniotic fluid in comparison to AFI

Objetivo: comparar a capacidade de diagnosticar oligoâmnio pela ultra-sonografa por meio de diferentes valores do maior bolsão de Iíquido amniótico, em comparação ao índice de líquido amniótico (ILA), em gestantes normais, de 36 a 42 semanas de gestação. Métodos: realizou-se um estudo descritivo de validação de método diagnóstico, incluindo 875 gestantes normais. Mediante um exame ultra-sonográfico obstétrico de rotina, foi feita a medida do maior boIsão de líquido amnitico para o diagnóstico de oligoâmnio, utilizando como padrão-ouro o índice de líquido amniótico. Os dados foram analisados por meio do cálculo da sensibilidade e da especificidade da medida do maior bolsão de líquido amniótico, utilizando os diferentes pontos de corte de 10, 20 a 30 mm, em comparação aos valores normais do índice de líquido amniótico determinados peIos percentis 2,5 e 10 nas respectivas idades gestacionais. Resultados: a medida do maior bolsão de Iíquido amniótico apresenta baixa sensibilidade para diagnosticar oligoâmnio quando se adotam os pontos de corte 10 e 20 mm, a boa sensibilidade e especificidade quando se adota 30 mm, quando comparadas as medidas do índice de líquido amniótico nos percentis 2,5 e 10 da curva normal. A sensibilidade e especificidade da medida do maior bolsão são melhores, quando se adota o ponto de corte de 30 mm para diagnosticar oligoâmnio em comparação ao percentil 2,5. Conclusões: a capacidade de diagnosticar oligoâmnio pela medida do maior bolsão é satisfatória apenas com o ponto de corte em 30 mm

Evoluçäo das características ecográficas da placenta, da posiçäo e da apresentaçäo fetal em gestações normais / Evolution of ultrasound characteristics of placenta and fetal position and presentation in normal pregnancies

Objetivo: avaliar as características ecográficas da gestaçäo normal, segundo o grau, a localizaçäo e a espessura placentária, a apresentaçäo e a posiçäo fetal ao longo da segunda metade da gestaçäo. Métodos: estudo descritivo, incluindo no minimo 120 medidas em cada idade gestacional, de 2.868 gestantes normais da cidade de Campinas, por meio de exame ultra-sonográfico de rotina, considerando-se os critérios de Grannum, Berkowitz, Hobbins (1979) para a classficaçäo do grau placentário e a medida da espessura placentária no local da inserçäo do cordäo umbilical. Resultados: a placenta grau 0 foi mais comum até 31 semanas, o grau I apresentou maior, freqüência após a 32ª semana e o grau II näo foi observado antes da 32ª semana. A placenta grau III foi mais freqüente a partir da 36ª semana. A espessura placentária aumentou significativamente com a gestaçäo. As localizações mais freqüentes foram a anterior e a posterior. A apresentaçäo cefálica foi a mais freqüente em todas as idades gestacionais, com apenas 1 por cento de apresentações pélvicas ao termo. A posiçäo fetal mais freqüente foi a de dorso lateral esquerda, seguida da de dorso lateral direita. Conclusões: os fatores estudados tiveram distribuiçäo similar à esperada para populações normais e podem servir como um padräo para a populaçäo brasileira