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

  • Review Article
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International Urogynecology Journal Aims and scope Submit manuscript

Abstract

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.

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Funding

Author SKD has previously had expenses paid by Contura (please see disclosure form). There are no funding disclosures for this review article.

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Authors and Affiliations

  1. Department of Obstetrics and Gynaecology, Epsom and St Helier University Hospitals NHS Trust, Dorking Road, London, UK

    Jemina Loganathan & Stergios K. Doumouchtsis

  2. St George’s University of London, London, UK

    Josephine Coffey & Stergios K. Doumouchtsis

  3. Laboratory of Experimental Surgery and Surgical Research “N.S. Christeas”, National and Kapodistrian University of Athens, Medical School, Athens, Greece

    Stergios K. Doumouchtsis

  4. School of Medicine, American University of the Caribbean, Cupecoy, Sint Maarten

    Stergios K. Doumouchtsis

  5. School of Medicine, Ross University, Miramar, FL, USA

    Stergios K. Doumouchtsis

Authors
  1. Jemina Loganathan
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  2. Josephine Coffey
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  3. Stergios K. Doumouchtsis
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Consortia

CHORUS: An International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women’s Health

Contributions

J Loganathan: Data collection and analysis, manuscript writing and editing.

J Coffey: Data collection and analysis, manuscript editing.

S Doumouchtsis: Conception of the idea. Project development, data analysis and manuscript editing.

Corresponding author

Correspondence to Jemina Loganathan.

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Loganathan, J., Coffey, J., Doumouchtsis, S.K. et al. Which patient reported outcomes (PROs) and patient reported outcome measures (PROMs) do researchers select in stress urinary incontinence surgical trials? – a systematic review. Int Urogynecol J 33, 2941–2949 (2022). https://doi.org/10.1007/s00192-022-05123-7

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  • DOI: https://doi.org/10.1007/s00192-022-05123-7

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