Study design
We performed a pragmatic, parallel arm, randomised controlled trial of patients with stress, urgency, or mixed UI to compare app-based treatment and care-as-usual in a general practice setting. The study design, recruitment challenges, and the primary outcome (non-inferiority of treatment after 4 months) have been published in detail elsewhere.7,12,13 In this report, we perform a secondary superiority analysis with a focus on the cost-effectiveness after 12 months.
We recruited adult Dutch women with stress, urgency or mixed UI via general practices, the lay press, and social media from July 2015 through July 2018. The full inclusion and exclusion criteria are presented in Appendix A. A baseline assessment was performed by a researcher/GP trainee (AMML and NJW), with participants asked to complete web-based questionnaires and a 3-day frequency-volume chart. Women then underwent a physical and urogynecological examination.14 The questionnaires and frequency-volume chart were repeated after 4 and 12 months.