Safety-in-use test of facial cosmetic products on normal and self-assessed sensitive skin subjects.

BACKGROUND: Safety-in-use (SIU) studies are commonly used by the cosmetic Industry to confirm the skin and ocular compatibility of cosmetic products under realistic in-use conditions. There are only limited case studies published about the design, outcome and interpretation of product SIU studies. OBJECTIVE: A series of SIU case studies is presented to demonstrate the considerations in study design and how the methodology can help in supporting skin and ocular safety profile of facial cosmetic products within a population of different ethnicities with normal and self-perceived sensitive skin. SUBJECTS/METHODS: In a series of four single-blinded SIU studies, more than 250 female study subjects of different ethnicities and with normal and self-assessed sensitive skin were asked to use different facial cosmetic products including lotions, essences and cleansers according to the instructed usage conditions of these products. Each study was specifically designed according to product usage scenarios and target consumer groups. The primary measures of safety were based on dermal evaluations by a dermatologist for erythema and dryness/scaling and by an ophthalmologist for any visible signs of an ocular condition on eyelids, conjunctivae and cornea. The study subjects were also asked for any self-perceived skin or eye reactions. Dermal and ocular irritation potential of the products under realistic product usage conditions was evaluated according to the measures. RESULTS: Across all studies, objectively and self-assessed mean scores for skin and eye effects did not indicate any cumulative response of the investigated products over the study period. CONCLUSIONS: As a suitable tool for assessing and establishing the skin and eye compatibility of facial cosmetic products, SIU studies can be designed according to specific consumer groups, skin types and product usage scenarios to better predict realistic in-use conditions. It can demonstrate the safe use of the investigated products for people of different ethnicities, skin types and with normal or self-assessed sensitive skin, single product use or regimen use. The test results are consistent with the inherently low irritation potential of the products.

How radical prostatectomy procedures have changed over the last 10 years in Italy: a comparative analysis based on more than 1500 patients participating in the MIRROR-SIU/LUNA and the Pros-IT CNR study.

PURPOSE: Therapeutic strategies for prostate cancer (PCa) have been evolving dramatically worldwide. The current article reports on the evolution of surgical management strategies for PCa in Italy. METHODS: The data from two independent Italian multicenter projects, the MIRROR-SIU/LUNA (started in 2007, holding data of 890 patients) and the Pros-IT-CNR project (started in 2014, with data of 692 patients), were compared. Differences in patients' characteristics were evaluated. Multivariable logistic regression models were used to identify characteristics associated with robot-assisted (RA) procedure, nerve sparing (NS) approach, and lymph node dissection (LND). RESULTS: The two cohorts did not differ in terms of age and prostate-specific antigen (PSA) levels at biopsy. Patients enrolled in the Pros-IT-CNR project more frequently were submitted to RA (58.8% vs 27.6%, p < 0.001) and NS prostatectomy (58.4% vs. 52.9%, p = 0.04), but received LND less frequently (47.7% vs. 76.7%, p < 0.001), as compared to the MIRROR-SIU/LUNA patients. At multivariate logistic models, Lower Gleason Scores (GS) and PSA levels were significantly associated with RA prostatectomy in both cohorts. As for the MIRROR-SIU/LUNA data, clinical T-stage was a predictor for NS (OR = 0.07 for T3, T4) and LND (OR = 2.41 for T2) procedures. As for Pros-IT CNR data, GS ≥ (4 + 3) and positive cancer cores ≥ 50% were decisive factors both for NS (OR 0.29 and 0.30) and LND (OR 7.53 and 2.31) strategies. CONCLUSIONS: PCa management has changed over the last decade in Italian centers: RA and NS procedures without LND have become the methods of choice to treat newly medium-high risk diagnosed PCa.

Collecting system percutaneous access using real-time tracking sensors: first pig model in vivo experience.

PURPOSE: Precise needle puncture of the renal collecting system is an essential but challenging step for successful percutaneous nephrolithotomy. We evaluated the efficiency of a new real-time electromagnetic tracking system for in vivo kidney puncture. MATERIALS AND METHODS: Six anesthetized female pigs underwent ureterorenoscopy to place a catheter with an electromagnetic tracking sensor into the desired puncture site and ascertain puncture success. A tracked needle with a similar electromagnetic tracking sensor was subsequently navigated into the sensor in the catheter. Four punctures were performed by each of 2 surgeons in each pig, including 1 each in the kidney, middle ureter, and right and left sides. Outcome measurements were the number of attempts and the time needed to evaluate the virtual trajectory and perform percutaneous puncture. RESULTS: A total of 24 punctures were easily performed without complication. Surgeons required more time to evaluate the trajectory during ureteral than kidney puncture (median 15 seconds, range 14 to 18 vs 13, range 11 to 16, p=0.1). Median renal and ureteral puncture time was 19 (range 14 to 45) and 51 seconds (range 45 to 67), respectively (p=0.003). Two attempts were needed to achieve a successful ureteral puncture. The technique requires the presence of a renal stone for testing. CONCLUSIONS: The proposed electromagnetic tracking solution for renal collecting system puncture proved to be highly accurate, simple and quick. This method might represent a paradigm shift in percutaneous kidney access techniques.

Isolated Grade 5 Renal Trauma in a Hemodynamically Stable Patient.

Isolated grade 5 renal trauma in a hemodynamically stable patient is rare. It is therefore unsurprising there are conflicting recommendations on management of these injuries from authorities including the AUA, EAU and SIU. We present a 26-year-old male with flank pain following a 3-m fall whilst bicycle riding off a ramp, who was found to have an isolated grade 5 renal injury (shattered kidney). He was managed with early angio-embolization and subsequent nephrectomy due to ongoing bleeding. Further reports of clinician experience with this type of renal injury are needed to clarify best practice in management.

Anticoncepción y cáncer de mama: te advierto que no quedes embarazada, pero, ¿qué hago al respecto? / Contraception and breast cancer: I warn you against getting pregnant, but what do I do about it?

La creciente incidencia de cáncer de mama (CM) en mujeres jóvenes nos obliga a repensar la forma en como asesoramos sobre el método anticonceptivo (MAC) en estas mujeres, cuya fertilidad puede ser variablemente afectada por los tratamientos. Se les aconseja, post tratamiento, evitar la gestación temporalmente, sin embargo se observa un patrón de uso insuficiente de MAC con elección de métodos anticonceptivos poco efectivos. El objetivo de la presente revisión es indagar en al necesidad anticonceptiva de mujeres jóvenes con cáncer de mama evaluando la evidencia científica sobre qué métodos anticonceptivos pueden o no utilizar, analizando especialmente el rol del sistema intrauterino liberado de levonorgestrel y la salpingectomía de la oportunidad como cirugía anticonceptiva con potencial reducción de riesgo de cáncer de ovario en pacientes con riesgos genético. Además se pretende brindar estrategias para evitar embarazos no planificados en este grupo de pacientes.

The increasing incidence of breast cancer (BC) in young women forces us to rethink the way in which we counsel on the contraceptive method (CM) in these women, whose fertility can be variably affected by the treatments. They are advised, post treatment, to avoid pregnancy temporarily, however a pattern of insufficient contraception use is observed with the choice on ineffective contraceptive need of young women with breast cancer, evaluating the scientific evidencially analyzing the role of the levonorgestrel-releasin intrautrien system and oppotunistic salpingectomy as a contaceptive surgery with potential ovarian cancer risk reduction in patients with genetic risk. Is is also intended to provide strategies to avoid unplanned pregnancies in this group of patients.

Uso de dispositivos intrauterinos (DIU) em nulíparas / Use of intrauterine devices (IUDs) in nulliparous women

Objetivo: Avaliar as evidências para o uso de dispositivos intrauterinos (DIUs) em mulheres nulíparas. Métodos: Revisão da lteratura,com seleção de publicações relacionadas ao uso do dispositivo intrauterino de cobre e do sistema intrauterino de levonorgestrel em nulíparas no período entre 1980 e 2018. Resultados: Os DIUs utilizados em nulíparas associam-se à elevada eficácia e segurança, sem riscos adicionais de doença inflamatória pélvica e infertilidade. Não há maior risco de perfurações e expulsões em nulíparas. Os DIUs apresentam boa tolerabilidade, aceitação e continuidade de uso, embora associem-se a maior grau de dor durante a inserção quando comparados ao uso em nulíparas. Conclusão: Os dispositivos intrauterinos são eficazes e seguros para nulíparas,recomendando-se que devam ser incluídos nas opções contraceptivas oferecidas rotineiramente.

The Use of Long Acting Reversible Contraceptives and the Relationship between Discontinuation Rates due to Menopause and to Female and Male Sterilizations / Uso de contraceptivos reversíveis de longa duração e a relação entre taxas de descontinuidade devido à menopausa e à esterilização de homens e mulheres

Abstract Introduction Women require effective contraception until they reach menopause. The long acting reversible contraceptives (LARC) and the depot-medroxyprogesterone acetate (DMPA, Depo-Provera(r), Pfizer, Puurs, Belgium) are great options and can replace possible sterilizations. Purpose To assess the relationship between the use of LARCs and DMPA and terminations ascribed to menopause and sterilizations in a Brazilian clinic. Methods We reviewed the records of women between 12 and 50 years of age attending the clinic that chose to use a LARC method or DMPA. Cumulative termination rates due to sterilization or because the woman had reached menopause were computed using single decrement life-table analysis over 32 years. We also examined all records of surgical sterilization at our hospital between the years 1980-2012. Results Three hundred thirty-two women had continuously used the same contraceptive until menopause, and 555 women had discontinued the method because they or their partners underwent sterilization. From year 20 to year 30 of use, levonorgestrel intrauterine-releasing system (LNG-IUS - Mirena(r), Bayer Oy, Turku, Finland; available since 1980), copper intrauterine device (IUD - available since 1980) and DMPA users showed a trend of cumulative higher discontinuation rates due to menopause when compared with the discontinuation rates due to sterilization. Over the study period, a steep decline in the use of sterilization occurred. Conclusion Over the past 15 years of research we have observed a trend: women usually preferred to continue using LARC methods or DMPA until menopause rather than decide for sterilization, be it their own, or their partners'. The annual number of sterilizations dropped in the same period. The use of LARC methods and DMPA until menopause is an important option to avoid sterilization, which requires a surgical procedure with potential complications.

Resumo Introdução Mulheres necessitam de contracepção até atingirem a menopausa. Os contraceptivos reversíveis de longa duração e o acetato de medroxiprogesterona de depósito (AMPD) são ótimas opções para substituir possíveis esterilizações. Objetivo Avaliar a relação entre o uso de contraceptivos reversíveis de longa duração (LARCs) e AMPD com terminações atribuídas à menopausa e a esterilizações em uma clínica brasileira. Métodos Revisamos os registros de mulheres entre 12 e 50 anos de idade atendidas em clínica e que escolheram usar LARC ou AMPD. Índices de terminação acumulada devido à esterilização ou à menopausa foram computados usando análise de tabela de vida durante 32 anos. Também examinamos todos os registros de cirurgias de esterilização em nosso hospital no período de 1980 a 2012. Resultados Trezentas e trinta e duas mulheres usaram continuamente o mesmo contraceptivo até a menopausa, e 555 mulheres não deram continuidade ao método pelo fato de elas ou seus parceiros terem se submetido à esterilização. De 20 a 30 anos de uso, usuários de sistema intrauterino de levonorgestrel, dispositivo intrauterino de cobre e AMPD apresentaram tendência de maiores índices de descontinuidade devido à menopausa quando comparados a índices de descontinuidade devido à esterilização. No período de estudo, ocorreu um declínio acentuado no uso de esterilização. Conclusão Nos últimos 15 anos do estudo, foi observada uma tendência na qual mulheres optaram mais por continuar usando LARC ou AMPD até a menopausa do que pela esterilização própria ou de seus parceiros. O número anual de esterilizações caiu no mesmo período. O uso de LARC e AMPD até a menopausa é uma opção importante para evitar a esterilização, que exige um procedimento cirúrgico com potenciais complicações.

Avaliação da qualidade de vida de pacientes portadoras de endometriose após inserção do Sistema Intra-Uterino Liberador de Levonorgestrel (SIU-LNg) / Assessment of quality of life of patients suffering from endometriosis after insertion of Intra-Uterine System Levonorgestrel-releasing (LNG-IUS)

Objetivos: Avaliar a qualidade de vida das mulheres com endometriose através da aplicação de um questionário estruturado, antes e após a inserção do SIU-LNg durante seis meses de seguimento. Métodos: Foi realizada uma pesquisa clínica, observacional, descritiva e prospectiva do tipo Estudo de Casos onde foram acompanhadas mulheres com endometriose associada à dor pélvica, através da aplicação de questionários, desde o momento da inserção do SIU-LNg. Resultados: Foram entrevistadas 10 portadoras, cujo perfil neste estudo, é de uma mulher entre 20-30 anos, casada, com curso superior. O padrão menstrual predominante, antes da inserção do SIU-LNg, era de ciclos regulares, duração de 6 ou mais dias e fluxo menstrual regular. Todas sofriam de sintomas pré-menstruais ou menstruais, sendo os principais dismenorréia, irritabilidade, depressão e cefaléia. O padrão menstrual após o SIU-LNg foi de diminuição do fluxo na maioria das pacientes (“spotting”). O efeito adverso mais freqüente no primeiro mês após a inserção foi a dismenorréia, com significativa melhora a partir do segundo mês. Houve apenas uma descontinuação do seguimento por sangramento irregular contínuo e dor. Conclusão: Em relação aos aspectos da qualidade de vida, houve melhora importante de sintomas depressivos, irritabilidade, incapacidade para eventos sociais, trabalho, estudo, perda de apetite, sono e vida sexual. As usuárias do SIU-LNg e portadoras de endometriose deste estudo apresentaram melhora na qualidade de vida e a atribuíram ao uso do método.

Objective: To assess the quality of life of women with endometriosis by the application of a structured questionnaire both before and after the insertion of the Levonorgestrel-Medicated Intrauterine System (LNG-IUS) for six months of follow up. Methods: It held clinical, observational, descriptive and prospective research of the type of cases study where women were accompanied with endometriosis associated with pelvic pain, through the application of questionnaires, from the moment of insertion of the LNG-IUS.Results: We interviewed 10 carriers, whose profile in this study, is a woman between 20-30 years, married, a university education. The menstrual pattern predominant before insertion of the SIU-LNg was regular cycles, duration of 6 or more days and regular menstrual flow. All suffered from premenstrual symptoms and menstrual, and the main dysmenorrhea, irritability, depression and headache. The menstrual pattern after the LNG-IUS was decreased flow in most patients ("spotting"). The most frequent side effect in the first month after insertion was the dysmenorrhea with significant improvement from the second month. There was only one discontinuation of the action by irregular bleeding continual and pain. Conclusions: For aspects of quality of life, there was significant improvement on depressive symptoms, irritability, incapacity for social events, work, study, loss of appetite, sleep and sexual life. The users of LNG-IUS and suffering from endometriosis of the study, showed a great improvement in quality of life and attributed about using the method.