Original Article

Analysis of primary and secondary outcome domains reported in randomised trials on surgery for female stress urinary incontinence. A systematic review

10.34057/PPj.2019.38.04.006

  • MARIA-PATRICIA RADA
  • CORNELIA BETSCHART
  • VASILIOS PERGIALIOTIS
  • JORGE MILHEM HADDAD
  • GABRIELE FALCONI
  • STERGIOS K. DOUMOUCHTSIS

Pelviperineology 2019;38(4):122-125

Introduction:

Published randomised controlled trials (RCTs) on surgery for female stress urinary incontinence (SUI) evaluated the efficacy and safety of different surgical options using a variety of outcomes and outcome measures. Our objective was to perform a systematic review of the primary and secondary outcomes, analyse their selection in different RCTs and evaluate research choices and priorities.

Methods:

A literature search was conducted using Embase, Medline and Cochrane databases. The primary and secondary outcomesreported across trials were analysed. We grouped different outcomes into domains (categories).

Results:

One hundred twenty-five RCTs, which enrolled 20757 women, were included in this study. A total of 4 primary and 7 secondary outcome domains were reported. The most prevalent primary outcome domain involved cure rates, being reported by 86.2% of the included RCTs. Complication rates had the highest prevalence among secondary outcome domains, being reported by 71% of RCTs. Sample size calculations were performed in approximately two thirds of studies that used 1 primary outcome and in an even smaller fraction of studies that reported 2 primary outcomes.

Conclusions:

A variation in selection of different primary and secondary outcomes as well as domains was confirmed. Complications may have been underreported as the majority of trials were potentially underpowered to evaluate complication rates.

Keywords: Stress urinary incontinence; Randomised controlled trials; Surgical interventions outcomes; Core outcome sets