Which patient reported outcomes (PROs) and patient reported outcome measures (PROMs) do researchers select in stress urinary incontinence surgical trials? - a systematic review

Introduction and hypothesis The mesh controversy has highlighted the need for robust evidence of treatment safety and efficacy, particularly in the surgical treatment of stress urinary incontinence (SUI). Current trials demonstrate heterogeneity in outcomes reported as well as outcome measures used, restricting the ability to synthesize data and produce robust research evidence (Doumouchtsis et al. 5). Patient-reported outcomes (PROs) should be a focus when evaluating SUI surgery given the quality-of-life nature of this condition affecting 25-45% women worldwide (Milsom and Gyhagen 1). As part of the first step in developing a core outcome set (COS) and measures set (COMS), we aimed to systematically review RCTs evaluating SUI surgery and extract PROs and outcome measures (PROMs) used. Materials and methods We searched databases including MEDLINE and Cochrane for RCTs evaluating SUI surgical treatments from inception to January 2020. Eligibility criteria included English language and female-only subjects. PROs and PROMs were extracted and grouped into a structured inventory. PROMs were assigned to domains based on predominant theme. Results Of 123 eligible RCTs, 116 (94%) included PROs. Forty-four different PROMs were utilized; most frequent was Patient Global Impression of Improvement (PGI-I). Fifteen PROMs were used once. The top five PROMs have evidence of validity and are highly recommended. Conclusions There is no consensus amongst relevant stakeholders regarding PROs or PROMs used in SUI surgery research. We propose that this consensus is required to standardize measurements and reporting and promote use of validated and reliable outcome measures. This systematic review forms the first step in the development process.