Evaluating Single-incision Slings in Female Stress Urinary Incontinence: The Usefulness of the CONSORT Statement Criteria

OBJECTIVE To evaluate the usefulness and applicability of the Consolidated Standards of Reporting Trials (CONSORT) for journal articles reporting randomized, controlled trials evaluating single-incision slings in the treatment of female stress urinary incontinence. METHODS Original articles reporting randomized, controlled trials assessing single-incision slings in the treatment of female stress urinary incontinence were searched for in the PubMed and Embase databases in 2011. Reporting quality was studied by 2 hospital pharmacists and 2 urologic surgeons. Primary outcome was the score out of 20 in the abstract CONSORT checklist. Secondary outcomes were the scores in the standard CONSORT checklist and the extension CONSORT additional items for trials assessing nonpharmacologic treatments. RESULTS Among 135 articles retrieved, 8 met the inclusion criteria and were assessed. Abstract scores ranged from 4.7-14.1. Standard scores were >10.0 out of 20 for most articles; the extension scores did not exceed 5.0 out of 10. Four reported trials were not identified as randomized in the title. The interventions were incompletely reported. Four articles reported whether blinding was achieved but lack of blinding was never discussed as a potential source of bias. Few articles reported the operators and centers characteristics and their impact on statistical analysis. The combination of the 3 checklists was considered a useful guideline to enhance and assess the reporting quality of a surgical trial. CONCLUSION Our results support the further use of CONSORT criteria as a basic standardized tool in all stages of clinical evaluation for any prosthetic device in female pelvic surgery. UROLOGY 80: 535-541, 2012. (c) 2012 Elsevier Inc.