The majority of women with urinary incontinence (UI) experience barriers to seek help. Often when they do seek help, they receive suboptimal care. This may lead to inadequate treatment and unnecessary high costs for society. An eHealth application could both improve care and reduce costs. Previously, we showed effectiveness of an app-based treatment for stress-, urgency- and mixed type UI after 4 months. Until now, long-term effectiveness and cost-effectiveness were not assessed in comparison to care-as-usual. 
The aims of this study are to assess effectiveness and cost-effectiveness of an app-based treatment for female stress-, urgency- and mixed type UI after 12 months in comparison to care-as-usual in primary care.

We performed a pragmatic, parallel arm, randomized controlled non-inferiority trial in Dutch primary care of female patients with ≥2 episodes per week of stress-, urgency-, or mixed type UI. 
Women were recruited through general practices and (social) media from 2015 through July 2018. We compared a stand-alone app-based treatment with pelvic floor muscle and bladder training to care-as-usual through a general practitioner according to Dutch and international guidelines for treatment of urinary incontinence. Assessment of the primary outcome measure, effectiveness after 4 months, was previously published.[1]
Now, we present effectiveness and cost-effectiveness after 12 months, which are defined as secondary outcomes. Outcomes of effectiveness were change of symptom severity from baseline (ICIQ-UI-SF) and change of impact on disease-specific and general quality of life (ICIQ-LUTS-QoL and EQ-5D-5L), these were assessed for superiority. Also we compared total costs, cost-effectiveness based on IIALY (Incontinence Impact Adjusted Life Years score) and cost-utility based on Quality Adjusted Life Years (QALY) score from a 1 year societal perspective.

In total, 262 women were eligible and randomized equally. In the app-based treatment group 89 (68%) women completed follow up, as for 83 (63.3%) women in the care-as-usual group. Both groups showed improvement with between group differences of 0.903 (95%CI -0.66 to 1.871) for severity of incontinence, 0.445 (-1.125 to 2.015) for impact of incontinence on quality of life and 0.001 (-0.041 to 0.043) for improvement of general quality of life. No treatment was superior over the other. Women in the intervention group gained, on average, 0.71 IIALYs and 0.89 QALYs. Women in the control group gained on average 0.66 IIALYs and 0.91 QALYs. Mean direct and indirect costs per participant per year in the app-based treatment group were €1520 including €87 UI specific costs and in the care-as-usual group €1680 including €191 UI specific costs. The incremental cost-effectiveness ratio was €3696 and the incremental cost-utility ratio was €-6379. In total, 65.6% of the 5000 replications in the bootstrap simulation were in the lower halve of the incremental cost-effectiveness plan, which means that they represented lower costs for the app-based treatment, shown in figure 1. The mean difference of effect between groups was minimal and smaller than the known margin for clinical relevance. Sensitivity analysis for increased costs for app-based treatment, and stratification for UI type and recruitment showed similar results.

After 12 months of treatment, both app-based treatment and care-as-usual for female stress-, urgency and mixed UI showed clinically relevant improvements of UI-symptoms and quality of life. There was no significant or clinically relevant difference between groups. 
App-based treatment was less expensive than care-as-usual, with a mean difference in total costs of €161 and in UI specific costs of €87 per patient per year. These results remained steady in scenario’s with higher costs for app-development and did not depend on type of incontinence (stress versus urgency) or recruitment method (through general practitioner or (social) media).

The app-based treatment for female stress-, urgency- and mixed UI is an equally effective, and cost-effective alternative for care-as-usual in general practice.

Loohuis AMM, Wessels NJ, Dekker JH, van Merode NAM, Slieker-ten Hove MC, Kollen BJ, Berger MY, van der Worp H, Blanker MH. App-based treatment for urinary incontinence non-inferior to care as usual in primary care. Results of a pragmatic, randomized controlled trial. Annals of Family Medicine 2020 (In press).