An animal experimental study on pubourethral ligament restoration with platelet rich plasma for the treatment of stress urinary incontinence.

Introduction: Minimally invasive methods for injured ligament and tendon restoration have been developed and gained popularity in recent years. Injury and relaxation of the pubourethral ligament (PUL) can lead to stress urinary incontinence (SUI). The aim of this study was to investigate the impact of injecting platelet rich plasma (PRP) into the PUL following its surgical transection resulting in SUI, confirmed by leak point pressure (LPP) measurements pre- and post-intervention in an experimental animal model. Material and methods: Twenty female adult Sprague-Dawley rats were assigned in 2 groups: 1) treatment group with transection of the PUL and application of PRP at the time of transection and at one month follow-up and 2) a control group, with transection of the PUL only. Leak point pressures (LPPs) were measured prior to transection, immediately following the transection and at 1 and 2 months in both groups. Results: The median LPPs for the control group were: LPP - preT: 35.6 (29.8-44.8) cmH2O, LPP - postT: 14.6 (5.8-19.0) cmH2O, LPP - 1 month: 27.3 (19.2-33.8) cmH2O, LPP - 2 months: 29.0 (27.0-34.0) cmH2O, whereas for the PRP group were: LPP-preT: 40.5 (33.2-46.3) cmH2O, LPP - postT: 15.7 (3.0-24.0) cmH2O, LPP - 1month: 31.6 (24.8-37.4) cmH2O, LPP - 2 months: 36.8 (32.5-45.4) cmH2O. PRP injections on transected PULs significantly increased LPPs at one month follow-up [31.6 cmH2O vs. 27.3 cmH2O, p = .043]. This effect was confirmed at two months [36.8 cmH2O vs. 29.0 cmH2O, p <.001]. Conclusions: Injection of PRP into transected PULs significantly improved LPPs at one and two months' follow-up. However, further experimental and clinical research is needed to evaluate the safety and efficacy of this treatment, in clinical practice

A protocol for developing, disseminating, and implementing a core outcome set for stress urinary incontinence.

INTRODUCTION: Randomized trials evaluating interventions for stress urinary incontinence (SUI) have been using variable outcome measures, reporting a variety of outcomes. Alongside this variation across studies, outcome-reporting flaws contribute to a limited use of research to inform clinical practice. The development and use of core outcome sets (COSs) in future trials would ensure that outcomes important to different stakeholders and primarily women with SUI are reported more consistently and comprehensively. METHODS: An international steering group including healthcare professionals, researchers, and women with urinary incontinence will guide the development of this COS. Potential outcomes will be identified through comprehensive literature reviews. These outcomes will be entered into an international, multiperspective online Delphi survey. All key stakeholders, including healthcare professionals, researchers, and women with urinary incontinence, will be invited to participate. The modified Delphi method encourages stakeholder group convergence toward collective agreement, also referred as consensus, core outcomes. DISCUSSION: Dissemination and implementation of the resulting COS within an international context will be promoted and reviewed. Embedding the COS for SUI within future clinical trials, systematic reviews and clinical practice guidelines could make a significant contribution to advancing the value of research in informing clinical practice, enhancing patient care and improving outcomes. The infrastructure created by developing a COS for SUI could be leveraged in other settings, for example, selecting research priorities and clinical practice guideline development

A protocol for developing, disseminating, and implementing a core outcome set (COS) for childbirth pelvic floor trauma research.

BACKGROUND: More than 85% of women sustain different degrees of trauma during vaginal birth. Randomized controlled trials on childbirth pelvic floor trauma have reported a wide range of outcomes and used different outcome measures. This variation restricts effective data synthesis, impairing the ability of research to inform clinical practice. The development and use of a core outcome set (COS) for childbirth pelvic floor trauma aims to ensure consistent use of outcome measures and reporting of outcomes. METHODS: An international steering group, within CHORUS, an International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women's Health, including academic community members, researchers, healthcare professionals, policy makers and women with childbirth pelvic floor trauma will lead the development of this COS. Relevant outcome parameters will be identified through comprehensive literature reviews. The selected outcomes will be entered into an international, multi-perspective online Delphi survey. Subsequently and based on the results of the Delphi surveys consensus will be sought on 'core' outcomes. DISCUSSION: Dissemination and implementation of the resulting COS within an international context will be supported and promoted. Embedding the COS for childbirth pelvic floor trauma within future clinical trials, systematic reviews, and clinical practice guidelines is expected to enrich opportunities for comparison of future clinical trials and allow better synthesis of outcomes, and will enhance mother and child care. The infrastructure created by developing a COS for childbirth pelvic floor trauma could be leveraged in other settings, for example, advancing research priorities and clinical practice guideline development

The Impact of Bacteriospermia on Semen Parameters: A Meta-Analysis

Objective: To evaluate the impact of bacteriospermia on semen parameters. Materials and methods: We used the Medline (1966-2017), Scopus (2004-2017), Clinicaltrials.gov (2008-2017), EMBASE, (1980-2017), LILACS (1985-2017) and Cochrane Central Register of Controlled Trials CENTRAL (1999-2017) databases in our primary search along with the reference lists of electronically retrieved full-text papers. Meta-analysis was performed with the RevMan 5.3 software. Results: Eighteen studies were finally included. Men were stratified in two groups, healthy controls (5,797 men) and those suffering from bacteriospermia (3,986 men). Total sperm volume was not affected by the presence of bacteriospermia when all pathogens were analyzed together (MD 0.02 95%CI -0.13,0.17). Both sperm concentration (MD -27.06, 95% CI -36.03, -18.08) and total sperm count (MD -15.12, 95% CI -21.08, -9.16) were significantly affected by bacteriospermia. Decreased rates of normal sperm morphology were also found (MD -5.43%, 95% CI -6.42, -4.44). The percentage of alive sperm was significantly affected by bacteriospermia (MD -4.39 %, 95% CI -8.25, -0.53).  Total motility was also affected by bacteriospermia (MD -3.64, 95% CI -6.45, -0.84). In addition to this, progressive motility was significantly affected (MD -12.81, 95% CI -18.09, -7.53). Last but not least, pH was importantly affected (MD 0.03, 95% Cl 0.01, 0.04). Conclusion: Bacteriospermia significantly affects semen parameters and should be taken in mind even when asymptomatic. Further studies should evaluate the impact of antibiotic treatment on semen parameters and provide evidence on fertility outcome

Anti-Müllerian Hormone Levels in Preeclampsia: A Systematic Review of the Literature

Objective: Serum Anti-Müllerian hormone (AMH) has been implicated in the pathogenesis of cardiovascular disease. Its prognostic value in determining the risk of developing preeclampsia remains, to date, unclear. The purpose of the present systematic review is to accumulate current evidence in this field. Materials and methods: We searched Medline (1966–2017), Scopus (2004–2017), Clinicaltrials.gov (2008–2017), EMBASE (1980-2017), LILACS (1986-2017) and Cochrane Central Register of Controlled Trials CENTRAL (1999-2017) databases. Results: Four studies were included in with a total number of 401 women. Among them 146 had preeclampsia while 232 were recruited as normotensive controls. Current data are suggestive of the potential predictive value of serum AMH as its levels seem to be lower among women that develop preeclampsia. One study reported that women with and AMH value below the 10th percentile of the studied population had a 3.3 increased risk of developing preeclampsia (OR 3.3, 95% CI 1.2–8.7, p = 0.01). Conclusion: Taking in mind these findings, future studies are needed in this field to establish optimal cut-off values and evaluate the specificity and sensitivity of this biomarker during the first trimester of pregnancy

Quality assessment of outcome reporting, publication characteristics and overall methodological quality in trials on synthetic mesh procedures for the treatment of pelvic organ prolapse for development of core outcome sets.

INTRODUCTION AND HYPOTHESIS: Variations in outcome measures and reporting of outcomes in trials on surgery for pelvic organ prolapse (POP) using synthetic mesh have been evaluated and reported. However, the quality of outcome reporting, methodology of trials and their publication parameters are important considerations in the process of development of Core Outcome Sets. We aimed to evaluate these characteristics in randomized controlled trials on surgery for POP using mesh. METHODS: Secondary analysis of randomized controlled trials on surgical treatments using synthetic mesh for POP previously included in a systematic review developing an inventory of reported outcomes and outcome measures. The methodological quality was investigated with the modified Jadad criteria. Outcome reporting quality was evaluated with the MOMENT criteria. Publication parameters included publishing journal, impact factor and year of publication. RESULTS: Of the 71 previously reviewed studies published from 2000 to 2017, the mean JADAD score was 3.59 and the mean MOMENT score was 4.63. Quality of outcomes (MOMENT) was related to methodological quality (JADAD) (rho = 0.662; p = 0.000) and to year of publication (rho = 0.262; p = 0.028). CONCLUSIONS: Methodological quality and outcome reporting quality appear correlated. However, publication characteristics do not have strong associations with the methodological quality of the studies. Evaluation of the quality of outcomes, methodology and publication characteristics are all an indispensable part of a staged process for the development of Core Outcome and Outcome Measure Sets

Obstetric anal sphincter injury: a systematic review of information available on the internet

Objective There is no systematic evaluation of online health information pertaining to obstetric anal sphincter injury. Therefore, we evaluated the accuracy, credibility, reliability, and readability of online information concerning obstetric anal sphincter injury. Materials and methods Multiple search engines were searched. The first 30 webpages were identified for each keyword and considered eligible if they provided information regarding obstetric anal sphincter injury. Eligible webpages were assessed by two independent researchers for accuracy (prioritised criteria based upon the RCOG Third and Fourth Degree Tear guideline); credibility; reliability; and readability. Results Fifty-eight webpages were included. Seventeen webpages (30%) had obtained Health On the Net certification, or Information Standard approval and performed better than those without such approvals (p = 0.039). The best overall performing website was http://www.pat.nhs.uk (score of 146.7). A single webpage (1%) fulfilled the entire criteria for accuracy with a score of 18: www.tamesidehospital.nhs.uk. Twenty-nine webpages (50%) were assessed as credible (scores ≥7). A single webpage achieved a maximum credibility score of 10: www.meht.nhs.uk. Over a third (21 out of 58) were rated as poor or very poor. The highest scoring webpage was http://www.royalsurrey.nhs.uk (score 62). No webpage met the recommended Flesch Reading Ease Score above 70. The intra-class coefficient between researchers was 0.98 (95% CI 0.96–0.99) and 0.94 (95% CI 0.89–0.96) for accuracy and reliability assessments. Conclusion Online information concerning obstetric anal sphincter injury often uses language that is inappropriate for a lay audience and lacks sufficient accuracy, credibility, and reliability

the impact of uterine immaturity on obstetrical syndromes during adolescence

Pregnant nulliparous adolescents are at increased risk, inversely proportional to their age, of major obstetric syndromes, including preeclampsia, fetal growth restriction, and preterm birth. Emerging evidence indicates that biological immaturity of the uterus accounts for the increased incidence of obstetrical disorders in very young mothers, possibly compounded by sociodemographic factors associated with teenage pregnancy. The endometrium in most newborns is intrinsically resistant to progesterone signaling, and the rate of transition to a fully responsive tissue likely determines pregnancy outcome during adolescence. In addition to ontogenetic progesterone resistance, other factors appear important for the transition of the immature uterus to a functional organ, including estrogen-dependent growth and tissue-specific conditioning of uterine natural killer cells, which plays a critical role in vascular adaptation during pregnancy. The perivascular space around the spiral arteries is rich in endometrial mesenchymal stem-like cells, and dynamic changes in this niche are essential to accommodate endovascular trophoblast invasion and deep placentation. Here we evaluate the intrinsic (uterine-specific) mechanisms that predispose adolescent mothers to the great obstetrical syndromes and discuss the convergence of extrinsic risk factors that may be amenable to intervention

Bisphenol A and its analogues: A comprehensive review to identify and prioritize effect biomarkers for human biomonitoring

Human biomonitoring (HBM) studies have demonstrated widespread and daily exposure to bisphenol A (BPA). Moreover, BPA structural analogues (e.g. BPS, BPF, BPAF), used as BPA replacements, are being increasingly detected in human biological matrices. BPA and some of its analogues are classified as endocrine disruptors suspected of contributing to adverse health outcomes such as altered reproduction and neurodevelopment, obesity, and metabolic disorders among other developmental and chronic impairments. One of the aims of the H2020 European Human Biomonitoring Initiative (HBM4EU) is the implementation of effect biomarkers at large scales in future HBM studies in a systematic and standardized way, in order to complement exposure data with mechanistically-based biomarkers of early adverse effects. This review aimed to identify and prioritize existing biomarkers of effect for BPA, as well as to provide relevant mechanistic and adverse outcome pathway (AOP) information in order to cover knowledge gaps and better interpret effect biomarker data. A comprehensive literature search was performed in PubMed to identify all the epidemiologic studies published in the last 10 years addressing the potential relationship between bisphenols exposure and alterations in biological parameters. A total of 5716 references were screened, out of which, 119 full-text articles were analyzed and tabulated in detail. This work provides first an overview of all epigenetics, gene transcription, oxidative stress, reproductive, glucocorticoid and thyroid hormones, metabolic and allergy/immune biomarkers previously studied. Then, promising effect biomarkers related to altered neurodevelopmental and reproductive outcomes including brainderived neurotrophic factor (BDNF), kisspeptin (KiSS), and gene expression of nuclear receptors are prioritized, providing mechanistic insights based on in vitro, animal studies and AOP information. Finally, the potential of omics technologies for biomarker discovery and its implications for risk assessment are discussed. To the best of our knowledge, this is the first effort to comprehensively identify bisphenol-related biomarkers of effect for HBM purposes.European Union Commission H2020-EJP-HBM4EU 733032HBM4EU Initiativ

POstLAparoscopic Reduction of pain By combining intraperitoneal normal salinE And the pulmonary Recruitment maneuver (POLAR BEAR trial). RCT to estimate reduction in pain after laparoscopic surgery when using a combination therapy of intraperitoneal normal saline and the pulmonary recruitment maneuver

Background: Shoulder pain and pain in the upper abdomen are common complaints after laparoscopy, sometimes surpassing the pain at incision sites. The incidence of shoulder pain ranges from 35 to 80%. Post-laparoscopic pain is caused by retention of carbon dioxide in the abdomen, which irritates the phrenic nerve and diaphragm, causing referred pain in the shoulder and in the upper abdomen. A promising strategy to reduce this post-laparoscopic pain is the pulmonary recruitment maneuver, which indirectly increases intraperitoneal pressure and thereby facilitates removal of residual carbon dioxide. An alternative strategy is the infusion of intraperitoneal normal saline. With normal saline infusion, carbon dioxide rises and escapes through the port sites. In addition, normal saline offers a physiologic buffer system to dissolve excess carbon dioxide. Methods/Design: This multicenter randomized controlled trial is conducted in two teaching hospitals in the Netherlands. Women between 18 and 65 years of age, with an ASA classification of Hl who are scheduled to undergo an elective laparoscopic procedure with benign gynecologic indication can participate. Following informed consent, participants are randomly allocated into two groups at the end of the surgical procedure. In the intervention group, the upper abdomen is filled with normal saline infusion with the patient in the Trendelenburg position. Then the anesthesiologist performs a standardized pulmonary recruitment maneuver with a pressure of 40 cm H2O. The trocar sleeve valves will be left open, so carbon dioxide can escape the abdominal cavity. With the patient in a neutral position the instruments are removed from the abdomen. In the control group, carbon dioxide is removed from the abdominal cavity at the end of surgery, with gentle abdominal pressure and passive exsufflation through the port sites, with open sleeve valves. The primary outcomes are the incidence and intensity of post-laparoscopic pain in the shoulder, upper abdomen and at the operation sites, at 8, 24 and 48 h after surgery. Secondary outcomes are postoperative use of analgesics, nausea, vomiting and pulmonary complications. Discussion: This study may reduce post-laparoscopic pain in women undergoing laparoscopy