A systematic review on outcome reporting in randomised controlled trials on surgical interventions for female stress urinary incontinence: a call to develop a core outcome set.

BACKGROUND

Several meta-analyses have identified methodological limitations in female stress urinary incontinence (SUI) trials, precluding the synthesis of primary studies and high-quality evidence.

OBJECTIVES

Evaluation of outcome measure selection and outcome reporting in randomised controlled trials (RCTs) on surgery for SUI.

SEARCH STRATEGY

Systematic review of RCTs identified from bibliographical databases, including Medline, Cochrane, and EMBASE.

SELECTION CRITERIA

Randomised controlled trials evaluating the efficacy and safety of surgical interventions for the management of female SUI.

DATA COLLECTION AND ANALYSIS

Two researchers independently assessed the included studies and documented outcomes.

MAIN RESULTS

Overall, 108 studies were identified that included 422 reported outcomes and 119 outcome measures. The three most common outcomes were cure rates (87 studies), quality of life (85 studies), and overactive bladder (78 studies). The median methodological quality rating was 3 (range 0-3) and the outcome reporting quality rating was 3 (range 0-5). Multinomial logistic regression analysis revealed that the methodological quality and use of validated questionnaire were significant predictors of the quality of outcome reporting (β = 0.538, P < 0.001; β = 0.218, P = 0.011, respectively).

CONCLUSIONS

Outcome reporting in SUI trials is highly variable. Until a core outcome set is developed and implemented, we propose an interim use of three commonly reported outcomes in each domain (treatment success rate - complete cure, partial improvement, or failure of response; urodynamic evaluation outcomes - overactive bladder (OAB), voiding dysfunction, and urodynamic stress incontinence; patient-reported outcomes - quality of life, sexual dysfunction, and patient satisfaction) with the use of validated questionnaires for patient-reported outcomes and subjective success rates. Complications should be also explicitly and comprehensively reported using validated outcome measures.

TWEETABLE ABSTRACT

There is significant variation in outcome reporting in SUI trials. Our systematic review findings aim to form the basis for the development of a core outcome set.