Urinary Incontinence Research: Compliance With Research Standards for Clinical Studies

Abstract

Objective: To perform an updated literature review to assess compliance with outcomes use and reporting guidelines. In 1997, the Urodynamics Society recommended standards of efficacy to be used for evaluation of treatment outcomes in urinary incontinence (UI). Studies published shortly after the release of these standards reported generally low rates of adherence.

Methods: We reviewed all 2017 articles related to UI in 3 urologic journals (Journal of Urology [JU], Neurourology and Urodynamics [NU], and Urology [UR]). Articles were assessed for compliance with 19 standards across 3 categories (methodology, pretreatment, and post-treatment). Analysis focused on overall and category specific compliance, as well as comparison of compliance between journals.

Results: A total of 78 articles met inclusion criteria for analysis. The mean overall compliance was 52% for all standards. JU demonstrated a higher compliance (63%) as compared to NU (50%) and UR (46%) (P <.01). No articles reviewed demonstrated 100% compliance with all standards. Only 23%, 6%, and 12% of JU, NU, and UR articles, respectively, demonstrated at least 75% compliance with all standards. In comparison of subcategory compliance, JU demonstrated a statistically higher methodology compliance (P <.01). In contrast, compliance with both pre- and post-treatment standards across all 3 journals demonstrated no statistically significant differences.

Conclusion: Overall, we found that a significant percentage of recent study on UI fails to meet suggested standards for use and reporting of outcomes. These data suggest that continued efforts are needed to improve the quality and reporting of UI research.