Clinical trials for stress urinary incontinence (SUI) require a robust, reliable, and responsive tool for objective assessment of SUI post-intervention. The Aberdeen Home Continence Stress Test (HCST) is a novel patient-reported objective assessment tool, aimed to be patient-friendly and reduce attrition rates by avoiding hospital appointments and prolonged pad-wearing.
We aim to describe the HCST for the first time and evaluate its reliability, diagnostic accuracy, and response to change.
A secondary analysis of the Single-Incision Mini-Slings (SIMS) study (a prospective multicentre randomised control trial (RCT) comparing two surgical treatments of SUI was performed. In SIMS (n = 600 women), the objective outcome was assessed by the 24-h pad test, while the patient-reported success rates were assessed using the Patient Global Impression of Improvement (PGI-I) at 15 months, 2 years and 3 years post-randomisation. Participants were instructed to perform the HCST before and after the 24-h pad test. The HCST was analysed in relation to reliability, validity, and the relationship between the 24-h pad test and HCST results and finally with regard to its responsiveness to change in PGI-I. (Trial registration-number ISRCTN93264234, registration date 14/01/2014).
Compared to the 24-h pad test, the sensitivity of the HCST ranged from 0.81-0.95, specificity was 0.76-0.79, negative predictive value was 0.96-0.99 and positive predictive value was 0.32-0.43. Reliability was indicated by high-performing Cronbach's alpha value (> 0.7). An improvement of ≥ 2 leakage groups on the HCST (for example from Large at baseline to Small leakage at follow-up) was strongly associated with patient-reported success on PGI-I (OR 4.38, 95% CI 2.31, 8.31).
The HCST is a valid and reliable patient-reported objective assessment tool that can be used for assessing SUI in surgical trials with good specificity, sensitivity, and consistency.
International urogynecology journal. 2023 Apr 13 [Epub ahead of print]
Catriona Young, David Cooper, Alyaa Mostafa, Mohamed Abdel-Fattah
The Aberdeen Centre for Women's Health Research, University of Aberdeen, Foresterhill, AB25 2ZD, Aberdeen, UK. ., Health Services Research Unit, University of Aberdeen, Aberdeen, UK., The Aberdeen Centre for Women's Health Research, University of Aberdeen, Foresterhill, AB25 2ZD, Aberdeen, UK.
PubMed http://www.ncbi.nlm.nih.gov/pubmed/37052645