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 (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

A systematic review on reporting outcomes and outcome measures in trials on synthetic mesh procedures for pelvic organ prolapse: Urgent action is needed to improve quality of research.

The use of synthetic mesh in pelvic organ prolapse surgery is being closely scrutinized because of serious concerns regarding life-changing complications such as erosion, pain, infection, bleeding, dyspareunia, organ perforation, and urinary problems. Randomized trials and their syntheses in meta-analysis offer a unique opportunity to assess efficacy and safety. However, outcomes and outcome measures need to be consistently selected, collected, and reported across randomized trials to be effectively combined in systematic reviews. AIMS: We evaluated outcome and outcome measure reporting across randomized controlled trials on surgical interventions using synthetic mesh for pelvic organ prolapse. METHODS: Systematic review of randomized controlled trials using synthetic mesh for the treatment of pelvic organ prolapse. The selected studies were evaluated using Jadad and MOMENT criteria. Outcomes and outcome measures were systematically identified and categorized. RESULTS: Seventy-one randomized trials were included. Twenty-four different types of mesh were identified. Included trials reported 110 different outcomes and 60 outcome measures. Erosion (40 trials, 78%), pain (29 trials, 56%), bleeding (31 trials, 61%), and dyspareunia (25 trials, 49%) were the most frequently reported outcomes. The longest follow up was 74 months. CONCLUSIONS: Most randomized trials evaluating surgical interventions using synthetic mesh for pelvic organ prolapse failed to report on clinically important outcomes and to evaluate efficacy and safety over the medium- and long-term. Developing and implementing a minimum data set, known as a core outcome set, in future vaginal prolapse trials could help address these issues

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

A systematic review of outcome and outcome-measure reporting in randomised trials evaluating surgical interventions for anterior-compartment vaginal prolapse: a call to action to develop a core outcome set

INTRODUCTION: We assessed outcome and outcome-measure reporting in randomised controlled trials evaluating surgical interventions for anterior-compartment vaginal prolapse and explored the relationships between outcome reporting quality with journal impact factor, year of publication, and methodological quality. METHODS: We searched the bibliographical databases from inception to October 2017. Two researchers independently selected studies and assessed study characteristics, methodological quality (Jadad criteria; range 1-5), and outcome reporting quality Management of Otitis Media with Effusion in Cleft Palate (MOMENT) criteria; range 1-6], and extracted relevant data. We used a multivariate linear regression to assess associations between outcome reporting quality and other variables. RESULTS: Eighty publications reporting data from 10,924 participants were included. Seventeen different surgical interventions were evaluated. One hundred different outcomes and 112 outcome measures were reported. Outcomes were inconsistently reported across trials; for example, 43 trials reported anatomical treatment success rates (12 outcome measures), 25 trials reported quality of life (15 outcome measures) and eight trials reported postoperative pain (seven outcome measures). Multivariate linear regression demonstrated a relationship between outcome reporting quality with methodological quality (β = 0.412; P = 0.018). No relationship was demonstrated between outcome reporting quality with impact factor (β = 0.078; P = 0.306), year of publication (β = 0.149; P = 0.295), study size (β = 0.008; P = 0.961) and commercial funding (β = -0.013; P = 0.918). CONCLUSIONS: Anterior-compartment vaginal prolapse trials report many different outcomes and outcome measures and often neglect to report important safety outcomes. Developing, disseminating and implementing a core outcome set will help address these issues

Risk of pregnancy complications in living kidney donors: A systematic review and meta-analysis

Living kidney donation is associated with glomerular hyperfiltration, predisposing for the development of chronic kidney disease. The present meta-analysis aims to gather current evidence and clarify whether kidney donors are at increased risk of future pregnancy complications. Medline, Scopus, Web of Science, CENTRAL and Google Scholar were systematically searched from inception to August 29, 2021. Observational studies comparing the rates of adverse pregnancy outcomes among kidney donors and non-donors were selected. Random-effects models were fitted to provide meta-analysis estimates, while the quality of evidence was appraised with the Grading of Recommendations Assessment, Development and Evaluation approach. Five studies were included, comprising 430 donors and 23,540 non-donors. Living kidney donation was associated with significantly higher risk of preeclampsia (OR: 2.86, 95% CI: 1.62–5.05, moderate quality of evidence), gestational hypertension (OR: 2.53, 95% CI: 1.11–5.74, low quality of evidence) and preterm birth (OR: 1.32, 95% CI: 1.01–1.74, moderate quality of evidence). The anticipated absolute rates of preeclampsia, gestational hypertension and preterm birth were 7.4%, 5.4% and 8.3%, respectively. The risk of gestational diabetes, cesarean delivery, low birthweight and fetal death was similar between the two groups (low quality of evidence). In conclusion, women with history of kidney donation are at significantly increased risk of preeclampsia, gestational hypertension and preterm birth in subsequent pregnancies, although the absolute rate of complications remains below 10%. Future studies should confirm these effects and improve potential donor counseling by individualizing the risk of adverse perinatal outcomes. © 2021 Elsevier B.V

Doppler parameters of renal hemodynamics in women with preeclampsia: A systematic review and meta-analysis

The present meta-analysis aims to compare renal arterial and venous Doppler parameters in women with preeclampsia and healthy pregnant controls. Medline, Scopus, Cochrane Central Register of Controlled Trials, Clinicaltrials.gov, and Google Scholar databases were systematically searched from inception to December 04, 2019. All observational studies reporting renal resistive index, pulsatility index, renal interlobar vein impedance, or pulse transit time among preeclamptic and healthy pregnant women were held eligible. Subgroup analysis was conducted on the basis of disease onset and side of measurement. Both pair-wise and network meta-analysis were performed using Review Manager 5.3 and R-3.4.3 software. Fourteen studies were included, with a total of 1118 women. No difference of renal resistive (MD: 0.00, 95% CI: [−0.03, 0.04]) and pulsatility index (MD: −0.01, 95% CI: [−0.14, 0.12]) was evident between the two groups. Renal interlobar vein impedance was estimated to be significantly higher in preeclampsia (MD: 0.07, 95% CI: [0.06, 0.09]), while venous pulse transit time was significantly lower (MD: −0.10, 95% CI: [−0.14, −0.05]) in women with the disease. Subgroup analysis indicated that early-onset preeclampsia was associated with significantly elevated renal interlobar vein impedance and lower venous pulse transit time than late-onset disease. The outcomes of the present meta-analysis suggest that preeclampsia is characterized by venous hemodynamic dysfunction as it is associated with significantly elevated renal interlobar vein impedance and shorter venous pulse transit time. Future large-scale prospective studies should introduce cutoff values and determine the optimal timing of measurement in order to achieve optimal predictive accuracy. © 2020 Wiley Periodicals LL