Outcome reporting in randomized controlled trials (RCTs) on the pharmacological management of idiopathic overactive bladder (OAB) in women; a systematic review for the development of core outcome sets (COS)

Introduction and hypothesis
Evidence on OAB management remains suboptimal and methodological limitations in randomized control trials (RCTs) affect their comparability. High quality meta-analyses are lacking. This study aimed to compare selection and reporting of outcomes and outcome measures across RCTs as well as evaluate methodological quality and outcome reporting quality as a first stage in the process of developing core outcome sets (COS).

Methods
RCTs were searched using Pubmed, EMBASE, Medline, Cochrane, ICTRP and Clinicaltrials.gov from inception to January 2020, in English language, on adult women. Pharmacological management, interventions, sample size, journal type and commercial funding were documented. Methodological and outcome reporting quality were evaluated using JADAD and MOMENT scores.

Results
Thirty-eight trials (18,316 women) were included. Sixty-nine outcomes were reported, using 62 outcome measures. The most commonly reported outcome domains were efficacy (86.8%), safety (73.7%) and QoL (60.5%). The most commonly reported outcomes in each domain were urgency urinary incontinence episodes (UUI) (52.6%), antimuscarinic side effects (76.3%) and change in validated questionnaire scores (36.8%).

A statistically significant correlation was found between JADAD and MOMENT (Spearman’s rho?=?0.548, p?
Conclusions
Development of COS and core outcome measure sets will address variations and lead to higher quality evidence. We recommend the most commonly reported outcomes in each domain, as interim COS. For efficacy we recommend: UUI episodes, urgency and nocturia episodes; for safety: antimuscarinic adverse events, other adverse events and discontinuation rates; for QoL: OAB-q, PPBC and IIQ scores.

Contributors

Reem Moussa, Maria Patricia Rada, Constantin Durnea, Gabriele Falconi, Cornelia Betschart, Jorge Milhem Haddad, Philip Sedgwick, Stergios K. Doumouchtsis & CHORUS: An International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women’s Health (i-chorus.org)

Publication

Journal: Int Urogynecol J
Volume:
Issue:
Pages: -
Year: 2022
DOI: 10.1007/s00192-021-05040-1

Further Study Information

Current Stage: Completed
Date:
Funding source(s):

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Method(s)

- Systematic review

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