1,721,252 research outputs found

    Erectile Recovery After Radical Pelvic Surgery: Methodological Challenges and Recommendations for Data Reporting

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    INTRODUCTION: Erectile function (EF) outcomes after radical pelvic surgery vary widely among different studies, partly as a consequence of heterogeneity with regard to the data assessment and reporting methodology. AIM: Review the methodology of data assessment and reporting of studies evaluating EF outcomes after radical prostatectomy (RP), radical cystectomy (RC), and rectal surgery (RS) and provide detailed recommendations to conduct future high-quality research. METHODS: The MEDLINE database was searched for randomized clinical trials and open-label prospective or retrospective studies. MAIN OUTCOME MEASURE: The panel reviewed the modality of data assessment and reporting concerning 3 specific areas: preoperative patients assessment, surgical technique description, and postoperative patients management and follow-up. RESULTS: Overall, 280, 36, and 73 studies investigating EF after RP, RC, and RS, respectively, were included. Baseline EF was largely reported (88%) in studies on RP, but only 67% of the studies on either RC or RS assessed EF before surgery. Baseline comorbidities that could impact postoperative EF were reported in 62%, 64%, and 85% of studies on RP, RC, and RS, respectively. The type of surgical approach was provided in all studies, and surgical details relevant to EF (eg, nerve- or organ-sparing surgery) were reported by 86%, 81%, and 62% of studies on RP, RC, and RS, respectively. Conversely, surgeon experience was rarely reported across all studies. Validated tools were commonly used to assess postoperative EF (64% of studies for RP, 78% for RC, and 71% for RS). Only 41%, 17%, and 29% of studies on RP, RC, and RS, respectively, reported a follow-up of at least 2 years. Use of erectile dysfunction treatment after surgery was assessed by only 39%, 17%, and 4.1% of studies on RP, RC, and RS, respectively. Factors potentially influencing EF recovery (eg, urinary or fecal continence, urinary diversion) were commonly reported, but sexual desire after surgery was reported by only 18%, 42%, and 37% of studies on RP, RC, and RS, respectively. CLINICAL IMPLICATIONS: The use of a shared methodology for the assessment and reporting of data on EF outcomes after pelvic surgery would allow better estimation of EF outcomes after pelvic surgery. STRENGTHS & LIMITATIONS: The modality of data assessment and reporting among studies investigating EF outcome after pelvic surgery was systematically investigated to provide recommendations allowing a proper interpretation of data. CONCLUSION: Studies on EF outcomes after radical pelvic surgery should fulfill specific criteria concerning preoperative patient assessment, reporting of surgical details, and postoperative functional outcome evaluation and management. Capogrosso P, Pozzi EP, Celentano V, et al. Erectile Recovery After Radical Pelvic Surgery: Methodological Challenges and Recommendations for Data Reporting. J Sex Med 2020;17:7-16

    A Systematic Review of the Literature Demonstrates Some Errors in the Use of Decision Curve Analysis but Generally Correct Interpretation of Findings

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    Background. Decision curve analysis (DCA) is a widely used methodology in clinical research studies. Purpose. We performed a literature review to identify common errors in the application of DCA and provide practical suggestions for appropriate use of DCA. Data Sources. We first conducted an informal literature review and identified 6 errors found in some DCAs. We then used Google Scholar to conduct a systematic review of studies applying DCA to evaluate a predictive model, marker, or test. Data Extraction. We used a standard data collection form to collect data for each reviewed article. Data Synthesis. Each article was assessed according to the 6 predefined criteria for a proper analysis, reporting, and interpretation of DCA. Overall, 50 articles were included in the review: 54% did not select an appropriate range of probability thresholds for the x-axis of the DCA, with a similar proportion (50%) failing to present smoothed curves. Among studies with internal validation of a predictive model and correction for overfit, 61% did not clearly report whether the DCA had also been corrected. However, almost all studies correctly interpreted the DCA, used a correct outcome (92% for both), and clearly reported the clinical decision at issue (81%). Limitations. A comprehensive assessment of all DCAs was not performed. However, such a strategy would not influence the main findings. Conclusions. Despite some common errors in the application of DCA, our finding that almost all studies correctly interpreted the DCA results demonstrates that it is a clear and intuitive method to assess clinical utility

    Phase I and phase II clinical trials for the treatment of male sexual dysfunction-a systematic review of the literature

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    INTRODUCTION: The prevalence of sexual dysfunctions has increased over the last decades; despite a number of available treatments for erectile dysfunction (ED), premature ejaculation (PE), and Peyronie's disease (PD), still several unmet therapeutic needs deserve to be fulfilled. The aim of this review is to detail on phase I and II clinical trials investigating novel medical treatments for ED, PE, and PD. AREAS COVERED: We conducted a systematic review of the literature including both published and ongoing phase I and II registered trials focused on medical treatment of ED, PE, and PD during the last 5 years. A total of 35 trials have been identified. Most studies (63%) investigated ED treatments and 26% were still ongoing. Stem cells (SCs) therapy was assessed in 28% of trials. EXPERT OPINION: SCs therapy represent a promising treatment for ED although only few patients have been treated to date. Likewise, the oral selective oxytocin receptor antagonists for treating PE showed excellent safety profile and deserve further investigations in phase III trials. Preliminary results of novel topical treatments for PD with fibrinolytic and antiinflammatory drugs are encouraging, but urgently need to be confirmed in large placebo-controlled trials
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