Optimizing the fabrication of electrospun nanofibers of prochlorperazine for enhanced dissolution and permeation properties.

Despite being an approved antiemetic for more than five decades, the clinical usefulness of prochlorperazine is limited by its low solubility and inconsistent absorption in the gastrointestinal tract, which presents challenges for nanotherapeutic interventions. Here, we report the preparation of a highly soluble and permeable nanofiber formulation of prochlorperazine using the Quality-by-Design approach. The final nanofiber formulation with drug entrapment of 88.02 ± 1.14 % was obtained at 20.0 kV, with a flow rate of 0.5 ml/h and tip-to-collector distance of 19.9 cm. Physio-mechanical properties, such as thickness (0.42 ± 0.02 mm), pH resistance (7.04 ± 0.08), folding endurance (54 ± 5), and tensile strength (0.244 ± 0.02 N.mm-2), were appropriate for packaging and application to oromucosal surfaces. The content uniformity (93.48-106.63 %) and weight variation (<1.8 mg) of the optimal nanofiber formulation were within the permissible limits prescribed for orodispersible films. Microscopical investigations confirm a randomly deposited and dense network of woven nanofibers with an average diameter of 363 ± 5.66 nm. The drug particles were embedded homogeneously on the fiber in the nanoform (4.27 ± 1.34 nm). The spectral analysis using TEM-EDS shows diffraction peaks of sulfur and chlorine, the elemental constituents of prochlorperazine. The drug was amorphized in the nanofiber formulation, as led by the decline of the crystallinity index from 87.25 % to 7.93 % due to electrostatic destabilization and flash evaporation of the solvent. The enthalpy of fusion values of the drug in the nanofiber mat decreased significantly to 23.6 J/g compared to its pristine form, which exhibits a value of 260.7 J/g. The nanofibers were biocompatible with oral mucosal cells, and there were no signs of mucosal irritation compared to 1 % sodium lauryl sulfate. The fiber mats rapidly disintegrated within <1 s and released ≈91.49 ± 2.1 % of the drug within 2 min, almost 2-fold compared to the commercial Stemetil MD® tablets. Similarly, the cumulative amount of the drug permeated across the unit area of the oromucosal membrane was remarkably high (31.28 ± 1.30 µg) compared to 10.17 ± 1.11 µg and 13.10 ± 1.79 µg from the cast film and drug suspension. Our results revealed these nanofiber formulations have the potential to be fast-dissolving oromucosal delivery systems, which can result in enhanced bioavailability with an early onset of action due to rapid disintegration, dissolution, and permeation.

Thiamine deficiency in pregnancy and lactation: implications and present perspectives.

During pregnancy, many physiologic changes occur in order to accommodate fetal growth. These changes require an increase in many of the nutritional needs to prevent long-term consequences for both mother and the offspring. One of the main vitamins that are needed throughout the pregnancy is thiamine (vitamin B1) which is a water-soluble vitamin that plays an important role in many metabolic and physiologic processes in the human body. Thiamine deficiency during pregnancy can cause can have many cardiac, neurologic, and psychological effects on the mother. It can also dispose the fetus to gastrointestinal, pulmonological, cardiac, and neurologic conditions. This paper reviews the recently published literature about thiamine and its physiologic roles, thiamine deficiency in pregnancy, its prevalence, its impact on infants and subsequent consequences in them. This review also highlights the knowledge gaps within these topics.

Naringenin improves ovarian health by reducing the serum androgen and eliminating follicular cysts in letrozole-induced polycystic ovary syndrome in the Sprague Dawley rats.

Polycystic ovary syndrome (PCOS) is most common in women of reproductive age, giving rise to androgen excess and anovulation, leading to infertility and non-reproductive complications. We explored the ameliorating effect of naringenin in PCOS using the Sprague Dawley (SD) rat model and human granulosa cells. Letrozole-induced PCOS rats were given either naringenin (50 mg/kg/day) alone or in combination with metformin (300 mg/kg/day), followed by the estrous cycle, hormonal analysis, and glucose sensitivity test. To evaluate the effect of naringenin on granulosa cell (hGC) steroidogenesis, we treated cells with naringenin (2.5 µM) alone or in combination with metformin (1 mM) in the presence of forskolin (10 µM). To determine the steroidogenesis of CYP-17A1, -19A1, and 3ßHSD2, the protein expression levels were examined. Treatment with naringenin in the PCOS animal groups increased ovulation potential and decreased cystic follicles and levels of androgens. The expression levels of CYP-17A1, -19A1, and 3ßHSD2, were seen restored in the ovary of PCOS SD rats' model and in the human ovarian cells in response to the naringenin. We found an increased expression level of phosphorylated-AKT in the ovary and hGCs by naringenin. Naringenin improves ovulation and suppress androgens and cystic follicles, involving AKT activation.

Data Science Implementation Trends in Nursing Practice: A Review of the 2021 Literature.

OBJECTIVES: The goal of this work was to provide a review of the implementation of data science-driven applications focused on structural or outcome-related nurse-sensitive indicators in the literature in 2021. By conducting this review, we aim to inform readers of trends in the nursing indicators being addressed, the patient populations and settings of focus, and lessons and challenges identified during the implementation of these tools. METHODS: We conducted a rigorous descriptive review of the literature to identify relevant research published in 2021. We extracted data on model development, implementation-related strategies and measures, lessons learned, and challenges and stakeholder involvement. We also assessed whether reports of data science application implementations currently follow the guidelines of the Developmental and Exploratory Clinical Investigations of DEcision support systems driven by AI (DECIDE-AI) framework. RESULTS: Of 4,943 articles found in PubMed (NLM) and CINAHL (EBSCOhost), 11 were included in the final review and data extraction. Systems leveraging data science were developed for adult patient populations and were primarily deployed in hospital settings. The clinical domains targeted included mortality/deterioration, utilization/resource allocation, and hospital-acquired infections/COVID-19. The composition of development teams and types of stakeholders involved varied. Research teams more frequently reported on implementation methods than implementation results. Most studies provided lessons learned that could help inform future implementations of data science systems in health care. CONCLUSION: In 2021, very few studies report on the implementation of data science-driven applications focused on structural- or outcome-related nurse-sensitive indicators. This gap in the sharing of implementation strategies needs to be addressed in order for these systems to be successfully adopted in health care settings.

Comprehensive multi-cohort transcriptional meta-analysis of muscle diseases identifies a signature of disease severity.

Muscle diseases share common pathological features suggesting common underlying mechanisms. We hypothesized there is a common set of genes dysregulated across muscle diseases compared to healthy muscle and that these genes correlate with severity of muscle disease. We performed meta-analysis of transcriptional profiles of muscle biopsies from human muscle diseases and healthy controls. Studies obtained from public microarray repositories fulfilling quality criteria were divided into six categories: (i) immobility, (ii) inflammatory myopathies, (iii) intensive care unit (ICU) acquired weakness (ICUAW), (iv) congenital muscle diseases, (v) chronic systemic diseases, (vi) motor neuron disease. Patient cohorts were separated in discovery and validation cohorts retaining roughly equal proportions of samples for the disease categories. To remove bias towards a specific muscle disease category we repeated the meta-analysis five times by removing data sets corresponding to one muscle disease class at a time in a "leave-one-disease-out" analysis. We used 636 muscle tissue samples from 30 independent cohorts to identify a 52 gene signature (36 up-regulated and 16 down-regulated genes). We validated the discriminatory power of this signature in 657 muscle biopsies from 12 additional patient cohorts encompassing five categories of muscle diseases with an area under the receiver operating characteristic curve of 0.91, 83% sensitivity, and 85.3% specificity. The expression score of the gene signature inversely correlated with quadriceps muscle mass (r = -0.50, p-value = 0.011) in ICUAW and shoulder abduction strength (r = -0.77, p-value = 0.014) in amyotrophic lateral sclerosis (ALS). The signature also positively correlated with histologic assessment of muscle atrophy in ALS (r = 0.88, p-value = 1.62 × 10-3) and fibrosis in muscular dystrophy (Jonckheere trend test p-value = 4.45 × 10-9). Our results identify a conserved transcriptional signature associated with clinical and histologic muscle disease severity. Several genes in this conserved signature have not been previously associated with muscle disease severity.

Polycystic ovarian syndrome-current pharmacotherapy and clinical implications.

Polycystic ovary syndrome (PCOS), the most common endocrinopathy in women is characterized by polycystic ovaries, chronic anovulation and hyperandrogenism. The treatment in PCOS is mainly symptomatic and involves lifestyle interventions and medications such as Metformin, Oral contraceptives and Antiandrogens. However, the management of PCOS is challenging and current interventions are not able to deal with outcomes of this syndrome. This review encompasses latest pharmacotherapeutic and non-pharmacotherapeutic interventions currently in use to tackle various symptomatic contentions in PCOS. Our focus has been mainly on novel therapeutic modalities for treatment/management of PCOS, like use of newer insulin sensitizers viz., Inositols, Glucagon-like peptide-1(GLP-1) agonists, Dipeptidyl pepdidase-4 (DPP-4) inhibitors, and sodium-glucose transport protein 2 (SGLT2) inhibitors. Also, evidence suggesting the use of vitamin D, statins, and Letrozole as emerging therapies in PCOS have been summarized in this review. Additionally, novel cosmetic techniques like electrolysis, laser and use of topically applied eflornithine to tackle the most distressing feature of facial hirsutism associated with PCOS, non-pharmacological therapy like acupuncture and the role of herbal medicine in PCOS management have also been discussed.

Knowledge and management of first-aid skills between medical and non-medical students at King Saud University.

Objectives: The study aims to determine the knowledge of first-aid management in medical and non-medical students and how they will act in certain situations. Methods: A cross-sectional study has been conducted on a convenience sampling of 375 (medical and non-medical) students. The research proposal was approved by the IRB Committee of King Saud University. The data has been obtained randomly by a validated questionnaire in a sample of 381 participants. The questionnaire had items related to knowledge and management of first-aid skills. The study was conducted from August 2020 to May 2021 in King Saud University. Results: The participants in the current study were medical (53.02%) and non-medical students (46.98%). Overall results showed that all students possessed a good knowledge of first-aid management, but medical students possessed more knowledge in comparison to non-medical students. The awareness of students related to first-aid management was found to be 32.02% 'high', 56.43% 'middle' and 11.54% 'low'. Moreover, results illustrated that medical students are more interested to attend first-aid courses than non-medical students by 60.4% and 43.6% respectively. Conclusion: The study revealed the participants' knowledge and management were not adequate. A statistically significant association was found between being a medical student and having a high level of knowledge about first aid. Awareness campaigns must be conducted to increase awareness among the non-medical community about first-aid knowledge, and how it is essential for every individual.

Long-term outcomes of primary cystocele repair by transvaginal mesh surgery versus laparoscopic mesh sacropexy: extended follow up of the PROSPERE multicentre randomised trial.

OBJECTIVE: To compare the effectiveness and safety of laparoscopic sacropexy (LS) and transvaginal mesh (TVM) at 4 years. DESIGN: Extended follow up of a randomised trial. SETTING: Eleven centres. POPULATION: Women with cystocele stage ≥2 (pelvic organ prolapse quantification [POP-Q], aged 45-75 years without previous prolapse surgery. METHODS: Synthetic non-absorbable mesh placed in the vesicovaginal space and sutured to the promontory (LS) or maintained by arms through pelvic ligaments and/or muscles (TVM). MAIN OUTCOME MEASURES: Functional outcomes (pelvic floor distress inventory [PFDI-20] as primary outcome); anatomical assessment (POP-Q), composite outcome of success; re-interventions for complications. RESULTS: A total of 220 out of 262 randomised patients have been followed at 4 years. PFDI-20 significantly improved in both groups and was better (but below the minimal clinically important difference) after LS (mean difference -7.2 points; 95% CI -14.0 to -0.05; P = 0.029). The improvement in quality of life and the success rate (LS 70%, 61-81% versus TVM 71%, 62-81%; hazard ratio 0.92, 95% CI 0.55-1.54; P = 0.75) were similar. POP-Q measurements did not differ, except for point C (LS -57 mm versus TVM -48 mm, P = 0.0093). The grade III or higher complication rate was lower after LS (2%, 0-4.7%) than after TVM (8.7%, 3.4-13.7%; hazard ratio 4.6, 95% CI 1.007-21.0, P = 0.049)). CONCLUSIONS: Both techniques provided improvement and similar success rates. LS had a better benefit-harm balance with fewer re-interventions due to complications. TVM remains an option when LS is not feasible. TWEETABLE ABSTRACT: At 4 years, Laparoscopic Sacropexy (LS) had a better benefit-harm balance with fewer re-interventions due to complications than Trans-Vaginal Mesh (TVM).

Hydroquinone Decorated with Alkyne, Quaternary Ammonium, and Hydrophobic Motifs to Mitigate Corrosion of X-60 Mild Steel in 15†wt.% HCl.

1-(6-Bromohexyloxy)-4-propargyloxybenzene upon quaternization with 3-dimethylamino-1-propanol and N,N-dimethyldodecylamine produced two new inhibitor molecules: N-[6-(4-Propargyloxyphenoxy)hexyl]-N,N-dimethyl-N-(3-hydroxypropyl)ammonium bromide (PHAB) and N-[6-(4-Propargyloxyphenoxy)hexyl]-N,N-dimethyl-N-dodecylammonium bromide (PDAB), respectively, in excellent yields. The inhibitor molecules were characterized by elemental analysis, Fourier transform infrared spectroscopy, 1 H NMR, and 13 C NMR spectroscopy. The inhibitors were evaluated for X-60 mild steel corrosion in 15 wt.% HCl using different electrochemical and gravimetric techniques. The potentiodynamic polarization confirms both the inhibitors as mixed-type corrosion inhibitors. A low concentration (15 ppm) of PDAB has demonstrated excellent corrosion inhibition efficiencies of 97%, 98%, and 86% at 25 °C, 50 °C, and 70 °C, respectively, for 24 h exposure time. SEM and EDX spectra reveal that the adsorptions of corrosion inhibitors on X-60 mild steel create a protective film that serves as a barrier to mitigate the corrosion process. The X-ray photoelectron spectroscopy confirmed the chemical interaction between the corrosion inhibitors and mild steel, which was predicted by the Langmuir adsorption model. Assembly of inhibitive motifs of the alkyne, π-electron-rich aromatic, quaternary ammonium and C12 alkyl chain hydrophobe in PDAB has augmented its inhibiting action.

Cardiovascular Risk Reduction in Rural Women: A Literature Synthesis.

BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death in most countries. Lack of awareness of the impact CVD has on women is a continuing problem. Rural women are at a great risk for CVD and have specific barriers to early recognition and to access to treatment. OBJECTIVE: The purpose of this systematic review was to identify how the state of the science for rural women and CVD has progressed over the last decade. METHODS: Searches were conducted using the databases Cochrane, PubMed, and CINAHL with 5 major subject headings. The search resulted in the identification of 571 articles. Specific exclusion criteria resulted in an in-depth review of 15 articles. Two of the authors reviewed each article for scientific merit and interrater reliability. RESULTS: Most studies were conducted in the United States (67%). Four studies focused on CVD knowledge; one, on physical activity; one, on diet plus other factors; one, on the effect of dried curry leaf powder and cucumber slices on hyperlipidemia; and one each, on waist circumference, exposure to smoke from wood stoves, and social support. Five of the 15 studies focused on more than 1 component, most on diet and physical activity. CONCLUSIONS: Depth in a body of knowledge on any 1 topic, such as the most efficacious means to decrease CVD risk factors in rural women and increase health promotion activities in the population, is lacking. Another area of concern is the lack of research articles published in cardiovascular journals that include CVD in rural women.

[Assessment of pelvic floor muscle training programs and urinary incontinence in women: A literature Review]. / Évaluation des programmes d'entraînement musculaire du plancher pelvien et incontinence urinaire chez la femme : revue de la littérature.

OBJECTIVES: Pelvic floor rehabilitation is efficient for the first line treatment of urinary incontinence in women. However, several questions remain as regards the best pelvic floor muscle training program to recommend. The objective was perform a literature review regarding the muscular strengthening program to recommend to treat stress or mixed urinary incontinence in women. METHODS: We performed a systematic review of studies on the topic using Medline's database covering the 10 last years. Among the 1130 articles that were identified, we retained 6 for our analysis. RESULTS: Given the heterogeneity of the exercise programs, it was impossible to exhaustively and comparatively analyze their efficacies. However, a significant improvement is noted when the exercises are based on the muscular training principles of the American College of Sports Medicine. They combine long and short contractions with the practice of the knack in situations of pressure exertion and are part of a self-rehabilitation program based on the needs of the patient and the individual's progression. CONCLUSION: Current knowledge does not allow us to recommend an optimal muscle training program to treat female urinary incontinence. Research must be conducted to evaluate different muscular training regimens but also their integration into a program based on personal needs as well as factors of adherence to the treatment of patients.

Differences in glycemic control across world regions: a post-hoc analysis in patients with type 2 diabetes mellitus on dual antidiabetes drug therapy.

OBJECTIVE: This post-hoc analysis of the EDGE (Effectiveness of Diabetes control with vildaGliptin and vildagliptin/mEtformin) study assessed inter-regional differences in baseline characteristics and response to treatment intensification with dual oral antidiabetes drugs (OADs) in patients with type 2 diabetes mellitus (T2DM). METHODS: Patients with T2DM inadequately controlled with first-line monotherapy were assigned to receive a dipeptidyl peptidase-4 (DPP-4) inhibitor, vildagliptin, or comparator OADs as add-on dual therapy. The primary effectiveness end point (PEP) was achieving glycated hemoglobin (HbA1c) reduction >0.3% without hypoglycemia, peripheral edema, discontinuation owing to gastrointestinal events or weight gain ⩾5% at 12 months. The secondary effectiveness end point (SEP) was achieving HbA1c of <7% without hypoglycemia or weight gain ⩾3% at 12 months. RESULTS: Baseline characteristics of patients (N=43 791), including mean HbA1c (8.2%), varied across regions. Baseline age (62.3 years) and T2DM duration (6.3 years) were greater in patients from Europe than those from India and the Middle East (age: 51.8 and 52.1 years; T2DM duration: 4.3 and 4.2 years, respectively). The probability of achieving PEP with dual therapy was higher in India (odds ratio (OR): 1.5), Latin America (OR: 1.2) and Middle East (OR: 2.0) than in Europe (OR: 0.8) and East Asia (OR: 0.3). Achievement of SEP in patients receiving dual therapy was greater in Latin America (OR: 1.7) and Middle East (OR: 1.7). Vildagliptin add-on therapy allowed more patients to achieve SEP across regions. Women aged ⩾45 years less often attained glycemic target (HbA1c<7%) without significant weight gain ⩾5% compared with women aged <45 years (OR: 0.876, 95% confidence interval: 0.774, 0.992; P=0.037). CONCLUSIONS: Baseline HbA1c and T2DM duration differed considerably across all regions. Treatment intensification with second OAD, particularly with a DPP-4 inhibitor vildagliptin, resulted in good treatment response without tolerability issues despite delayed intensification of failing monotherapy across regions.

Automated brain volumetrics in multiple sclerosis: a step closer to clinical application.

BACKGROUND: Whole brain volume (WBV) estimates in patients with multiple sclerosis (MS) correlate more robustly with clinical disability than traditional, lesion-based metrics. Numerous algorithms to measure WBV have been developed over the past two decades. We compare Structural Image Evaluation using Normalisation of Atrophy-Cross-sectional (SIENAX) to NeuroQuant and MSmetrix, for assessment of cross-sectional WBV in patients with MS. METHODS: MRIs from 61 patients with relapsing-remitting MS and 2 patients with clinically isolated syndrome were analysed. WBV measurements were calculated using SIENAX, NeuroQuant and MSmetrix. Statistical agreement between the methods was evaluated using linear regression and Bland-Altman plots. Precision and accuracy of WBV measurement was calculated for (1) NeuroQuant versus SIENAX and (2) MSmetrix versus SIENAX. RESULTS: Precision (Pearson's r) of WBV estimation for NeuroQuant and MSmetrix versus SIENAX was 0.983 and 0.992, respectively. Accuracy (Cb) was 0.871 and 0.994, respectively. NeuroQuant and MSmetrix showed a 5.5% and 1.0% volume difference compared with SIENAX, respectively, that was consistent across low and high values. CONCLUSIONS: In the analysed population, NeuroQuant and MSmetrix both quantified cross-sectional WBV with comparable statistical agreement to SIENAX, a well-validated cross-sectional tool that has been used extensively in MS clinical studies.

[Study of the factors motivating refusal of women to participate to a randomized clinical trial in gynecological surgery. Retrospective observational bicentric study]. / Étude des facteurs motivant le refus des femmes de participer à un essai clinique randomisé en chirurgie gynécologique. Étude observationnelle rétrospective bicentrique.

INTRODUCTION: Randomized controlled trials (RCT) in surgery are often subject to difficulties inherent in the study design and recruitment of patients. Women's participation rate to RCTs in surgery is relatively low and varies from 30 to 70%. These recruitment problems might induce a weak scientific value and even stop the study. Thus, optimizing recruitment is a challenge for surgical research. In contemporary literature, we lack data on motivations and profile of women who refuse to participate in a RCT in surgery. OBJECTIVE: To explore the potentially influential factors affecting women's decision to decline participation in PROSPERE trial, comparing laparoscopic sacrocolpopexy (LSCP) to vaginal mesh for cystocele repair. PATIENT AND METHOD: Retrospective, observational, qualitative, bicentric study conducted in the department of gynecology of Poissy and Lille hospitals. Patients included were those who refused to participate to PROSPERE trial in both centers. Factors of non-participation in the trial were recorded at the time of the first visit. A control group consisted of women who agreed to participate in the trial was also analyzed. RESULTS: In both centers, 139 were eligible to participate in the trial but 35 of them (25%) refused. Thirty-two women agreed to declare their refusal motivations. Vaginal mesh was finally performed in 18 (56,2%) patients and LSCP in 14 patients (43,8%). The control group consisted of 20 women, including 9 operated by vaginal mesh and 11 by LSCP. Patient's characteristics were similar in the both groups. Most influencing factor in refusal for participation was "previous choice of technique" in 50% cases (16/32), followed by "geographical remoteness and difficulties for additional visits" in 40.6% cases (13/32), and finally by "do not accept the concept of randomization" in 21.8% cases (7/32). The most influencing factor in women's acceptance was interest in helping others by "supporting medical research" in 100% cases (20/20), followed by "potential personal benefits and close follow-up" in 60% (12/20). CONCLUSION: Our study identified the most influential factors relevant to women decision-making whether or not to participate in RCT in surgery. A number of factors leading to refusal of participation are potentially correctable leading to better recruitment rates in future RCTs. Optimization of information on the principle of randomization, limiting the number of additional visits could help researchers improve participation rates.

[Severe post-obstetric perineal tears: Medium-term consequences on women's quality of life]. / Déchirures périnéales post-obstétricales sévères : conséquences à moyen terme sur la qualité de vie des femmes.

AIMS: To assess the prevalence of anal (AI) and urinary (UI) incontinence at medium term after 3rd and 4th degree anal sphincter tears and their impact on sexuality and women's quality of life. MATERIAL: It is a case-control, single center study. Sixty-eight primiparous women delivered with severe anal sphincter tear (exposed group) were compared to 136 women without (control group). Questionnaires on anal and urinary incontinence, sexual function and quality of life, using validated scores, were sent between two and five years after the first delivery. Maternal and obstetric data were collected retrospectively on the medical files. RESULTS: The answer rate was 22.5% (46/204) of which 30.9% (21/68) in the exposed group and 18.4% (25/136) in the unexposed group. In case of severe anal sphincter tear, 57.1% of women reported an AI vs 48% in the control group (P=0.76). The rate of AI for liquid stool was significantly higher in the exposed group (P=0.05). Patients with severe perineal tears reported a greater impact of symptoms on their quality of life but the difference with the control group was not significant. CONCLUSIONS: The severity of symptoms related to anal sphincter tears is common and underestimated. Preventive measures must be improved in order to maintain women's quality of life. LEVEL OF EVIDENCE: 4.

[Use of glue in laparoscopic sacrocolpopexy. A comparative study about 32 cases]. / Utilisation de la colle chirurgicale dans la promontofixation laparoscopique. Étude comparative à propos de 32 cas.

AIM: To study the impact of the use of glue instead of some laparoscopic sutures, on the operative time, the morbidity, and the short-term anatomical and functional results in the laparoscopic sacrocolpopexy (LSCP). PATIENTS AND METHODS: Thirty-two patients underwent a LSCP at Poissy-St-Germain-en-Laye University Hospital. The fixation of prostheses was made either exclusively by sutures (Group S), or by associating sutures (on traction sites) and biological glue (GroupC). Comparison was made after pairing on the number of prostheses associated surgery. Patients' satisfaction was assessed thanks to the validated PGI-I questionnaire. RESULTS: The mean operative time (178.7 [Group S] vs 173.1 minutes [Group C]) and the mean hospital stay (3.94 [Group S] vs 3.31 days [Group C]) were not significantly different. Anatomical results (POP-Q) and the mean satisfaction rate in the short-term were similar in both groups (1.67 [Group S] vs 1.30 [Group C]. Morbidity was also similar in both groups; no serious complications have been experienced. DISCUSSION AND CONCLUSION: The use of the glue in the LSCP did not significantly reduce the operative time. However, the use of glue for the adhesion of prostheses in addition to sutures has shown its safety and efficacy compared to the conventional technique (sutures exclusively) since the morbidity, the anatomical results and satisfaction rate are identical in the short-term. A study involving a larger number of patients with a longer follow-up seems necessary.

[Urinary incontinence in nulliparous women: prevalence and evaluation of self-perineal reeducation]. / Incontinence urinaire chez la femme nullipare: prévalence et évaluation de l'auto-rééducation périnéale.

AIMS: To assess the prevalence of urinary incontinence (UI) in a population of young nulliparous women and the effectiveness of self-perineal exercises in symptomatic women. MATERIAL: Three hundred and fifteen nulliparous students from French secondary establishments answered through a secure website, created for the study, an anonymous questionnaire about UI. The questionnaire included validated symptom scores (International Consultation on Incontinence Questionnaire-Short Form, ICIQ-UI SF) and quality of life (Contilife). Women who reported UI were asked to perform a self-perineal rehabilitation program for 8 weeks. A second questionnaire was completed after reeducation to assess the evolution of their UI. RESULTS: Among the 315 respondents, 92 women (29.2%) reported UI. The mean age was 23.0 (± 4.4) years in the continent group and 22.9 (± 3.6) years in the incontinent group. Only 24 of the 92 women with UI (26.1%) completed the reeducation program with a significant improvement in UI and quality of life (QoL). CONCLUSION: UI is a common disorder in young nulliparous women. Perineal self-exercises without the intervention of a professional could help to improve the disorders. LEVEL OF EVIDENCE: 5.

Incidence of and risk factors for severe hypoglycaemia in treated type 2 diabetes mellitus patients in the UK--a nested case-control analysis.

AIMS: To assess incidence rates (IRs) of and identify risk factors for incident severe hypoglycaemia in patients with type 2 diabetes newly treated with antidiabetic drugs. METHODS: Using the UK-based General Practice Research Database, we performed a retrospective cohort study between 1994 and 2011 and a nested case-control analysis. Ten controls from the population at risk were matched to each case with a recorded severe hypoglycaemia during follow-up on general practice, years of history in the database and calendar time. Using multivariate conditional logistic regression analyses, we adjusted for potential confounders. RESULTS: Of 130,761 patients with newly treated type 2 diabetes (mean age 61.7 ± 13.0 years), 690 (0.5%) had an incident episode of severe hypoglycaemia recorded [estimated IR 11.97 (95% confidence interval, CI, 11.11-12.90) per 10,000 person-years (PYs)]. The IR was markedly higher in insulin users [49.64 (95% CI, 44.08-55.89) per 10,000 PYs] than in patients not using insulin [8.03 (95% CI, 7.30-8.84) per 10,000 PYs]. Based on results of the nested case-control analysis increasing age [≥ 75 vs. 20-59 years; adjusted odds ratio (OR), 2.27; 95% CI, 1.65-3.12], cognitive impairment/dementia (adjusted OR, 2.00; 95% CI, 1.37-2.91), renal failure (adjusted OR, 1.34; 95% CI, 1.04-1.71), current use of sulphonylureas (adjusted OR, 4.45; 95% CI, 3.53-5.60) and current insulin use (adjusted OR, 11.83; 95% CI, 9.00-15.54) were all associated with an increased risk of severe hypoglycaemia. CONCLUSIONS: Severe hypoglycaemia was recorded in 12 cases per 10,000 PYs. Risk factors for severe hypoglycaemia included increasing age, renal failure, cognitive impairment/dementia, and current use of insulin or sulphonylureas.

[Outpatient vaginal hysterectomy, feasibility and morbidity: an observational study on thirty patients]. / Étude observationnelle de la faisabilité et de la morbidité de l'hystérectomie vaginale ambulatoire: à propos de 30 cas.

OBJECTIVE: Outpatient surgery is nowadays a major evolution axis of the surgery in France. Outpatient vaginal hysterectomy is possible with the use of electrosurgical bipolar vessel sealing allowing the reduction of operative time and postoperative pain. Our aim was to study the feasibility and morbidity of outpatient vaginal hysterectomy by assessment of postoperative pain and satisfaction. PATIENTS AND METHODS: Thirty patients were enrolled in this observational study. All patients underwent an outpatient vaginal hysterectomy with a standardized operative technic. Pain was evaluated by administering a 10 cm visual analogic scale (VAS) at the first and second postoperative days. The total duration of analgesic treatment was noticed. Patient's satisfaction was recorded at the postoperative visit one month after the intervention and by a telephonic interview. RESULTS: The mean operative time was 59.3 (25-110) minutes and the mean uterine weight was 170.2 (60-710) grams. No intraoperative complications were reported. Among the thirty patients, 3 (10%) were not discharged the same day. At the first and second postoperative days, the VAS was 4.40 and 4.35 respectively. The mean total duration of analgesic's use was 5 days (3-8 days). Patients were very satisfied of medical care in 36.7% of cases (11/30), satisfied in 53.3% (16/30) and not much satisfied in 10% (3/30). In total, 83.3% (25/30) have agreed to repeat the procedure in the ambulatory sector. DISCUSSION AND CONCLUSION: Outpatient vaginal hysterectomy seems to be a possible and a safe technique with a high patient's satisfaction in France at the present time.

Real-life efficacy and safety of vildagliptin compared with sulfonylureas as add-on to metformin in patients with type 2 diabetes mellitus in Germany.

OBJECTIVE: Metformin is an established first-line treatment for type 2 diabetes mellitus (T2DM) patients, but intensification of oral anti-diabetes therapy is usually required over time. A large observational study of 45,868 T2DM patients in 27 countries (EDGE) was conducted to compare the effectiveness and safety of vildagliptin as add-on therapy to another oral anti-diabetes drug (OAD) vs other dual OAD combinations. This report presents results from a post-hoc analysis of patients in Germany who received vildagliptin or a sulfonylurea (SU) in combination with metformin. RESEARCH DESIGN AND METHODS: Patients inadequately controlled with monotherapy became eligible only after the add-on treatment was finalized. Patients included were assigned to receive either vildagliptin or another OAD (SUs, thiazolidinediones, glinides, α-glucosidase inhibitors, or metformin; DPP-4 inhibitors or glucagon-like peptide-1 [GLP-1] mimetics/analogs were excluded). The primary end-point was the proportion of patients achieving a reduction in HbA1c >0.3% without peripheral edema, hypoglycemia, discontinuation due to gastrointestinal event, or weight gain ≥5%. RESULTS: Of 8887 patients enrolled in Germany, 6439 received vildagliptin and 971 received SUs as add-on to metformin. The primary end-point was reached in 34.9% and 29.6% of patients in the vildagliptin and SU groups, respectively, with an unadjusted odds ratio of 1.27 (95% CI = 1.09, 1.47; p = 0.001). HbA1c decreased in both cohorts from baseline (-0.7% with vildagliptin vs -0.5% with SUs), with a mean between-group difference of -0.2% (95% CI = -0.22, -0.09). The number of hypoglycemic events was 4-fold higher in the SU group than in the vildagliptin group (vildagliptin = 0.11%; SU = 0.41%). CONCLUSIONS: In a real-life setting, vildagliptin was associated with a numerically greater reduction in HbA1c, less hypoglycemia, and more patients reaching target HbA1c without hypoglycemia or weight gain compared with SUs. Open-label design and under reporting of adverse events are limitations of this post hoc analysis.