Introduction. Published randomised controlled trials (RCTs) on surgery for female stress urinary incontinence (SUI) evaluated the efficacy and safety of different surgical options using a variety of outcomes and outcome measures. Our objective was to perform a systematic review of the primary and secondary outcomes, analyse their selection in different RCTs and evaluate research choices and priorities. Methods. A literature search was conducted using Embase, Medline and Cochrane databases. The primary and secondary outcomesreported across trials were analysed. We grouped different outcomes into domains (categories). Results. One hundred twenty-five RCTs, which enrolled 20757 women, were included in this study. A total of 4 primary and 7 secondary outcome domains were reported. The most prevalent primary outcome domain involved cure rates, being reported by 86.2% of the included RCTs. Complication rates had the highest prevalence among secondary outcome domains, being reported by 71% of RCTs. Sample size calculations were performed in approximately two thirds of studies that used 1 primary outcome and in an even smaller fraction of studies that reported 2 primary outcomes. Conclusions. A variation in selection of different primary and secondary outcomes as well as domains was confirmed. Complications may have been underreported as the majority of trials were potentially underpowered to evaluate complication rates
ContributorsMARIA-PATRICIA RADA1,2, CORNELIA BETSCHART3, VASILIOS PERGIALIOTIS4, JORGE MILHEM HADDAD5, GABRIELE FALCONI6, STERGIOS K. DOUMOUCHTSIS1,4,7,8CHORUS, an International Collaboration for Harmonising Outcomes, Research and Standards in Urogynaecology and Women’s health (i-chorus.org)
1 Department of Obstetrics and Gynaecology, Epsom & St Helier University Hospitals NHS Trust, United Kingdom 2 2nd Department of Obstetrics and Gynaecology, “Iuliu Hatieganu” University of Medicine and Pharmacy, Cluj-Napoca, Romania 3 Department of Gynecology, University Hospital of Zurich, Zurich, Switzerland 4 Laboratory of Experimental Surgery and Surgical Research N S Christeas, Athens University Medical School, Athens, Greece 5 Department of Obstetrics and Gynaecology, Urogynaecology Division, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil6 Department of Obstetrics and Gynaecology, San Bortolo Hospital, Vicenza, Italy 7 St George’s University of London, London, United Kingdom 8 The American University of the Caribbean School of Medicine
Disease Category: Gynaecology
Disease Name: Stress urinary incontinence
Age Range: Unknown
Sex: Female
Nature of Intervention: Surgery
- None
- Systematic review of outcomes measured in trials
- Systematic review