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.
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.
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.
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.
International urogynecology journal. 2022 Mar 07 [Epub ahead of print]
Jemina Loganathan, Josephine Coffey, Stergios K Doumouchtsis, CHORUS: An International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women’s Health
Department of Obstetrics and Gynaecology, Epsom and St Helier University Hospitals NHS Trust, Dorking Road, London, UK. ., St George's University of London, London, UK., Department of Obstetrics and Gynaecology, Epsom and St Helier University Hospitals NHS Trust, Dorking Road, London, UK.