The impact of a mobile application-based treatment for urinary incontinence in adult women: Design of a mixed-methods randomized controlled trial in a primary care setting

Anne M.M. Loohuis, Nienke J. Wessels* (Corresponding Author), Petra Jellema, Karin M. Vermeulen, Marijke C. Slieker-ten Hove, Julia E.W.C. van Gemert-Pijnen, Marjolein Y. Berger, Janny H. Dekker, Marco H. Blanker

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

3 Citations (Scopus)
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Abstract

Aims: We aim to assess whether a purpose-developed mobile application (app) is non-inferior regarding effectiveness and cost-effective when used to treat women with urinary incontinence (UI), as compared to care as usual in Dutch primary care. Additionally, we will explore the expectations and experiences of patients and care providers regarding app usage. Methods: A mixed-methods study will be performed, combining a pragmatic, randomized-controlled, non-inferiority trial with an extensive process evaluation. Women aged ≥18 years, suffering from UI≥2 times per week and with access to a smartphone or tablet are eligible to participate. The primary outcome will be the change in UI symptom scores at 4 months after randomization, as assessed by the International Consultation on Incontinence Modular Questionnaire UI Short Form. Secondary outcomes will be the change in UI symptom scores at 12 months, as well as the patient-reported global impression of improvement, quality of life, change in sexual functioning, UI episodes per day, and costs at 4 and 12 months. In parallel, we will perform an extensive process evaluation to assess the expectations and experiences of patients and care providers regarding app usage, making use of interviews, focus group sessions, and log data analysis. Conclusion: This study will assess both the effectiveness and cost-effectiveness of app-based treatment for UI. The combination with the process evaluation, which will be performed in parallel, should also give valuable insights into the contextual factors that influence the effectiveness of such a treatment.

Original languageEnglish
Pages (from-to)2167-2176
Number of pages10
JournalNeurourology and Urodynamics
Volume37
Issue number7
DOIs
Publication statusPublished - 1 Sep 2018

Keywords

  • UT-Hybrid-D
  • Mixed methods
  • Mobile applications
  • Randomized controlled trial
  • Self-management
  • Urinary incontinence
  • Women
  • EHealth

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