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.