Self-Management of Urinary Incontinence Using eHealth : clinically relevant improvement, treatment effect and factors associated with success

Abstract: Background: Urinary incontinence is common among women, with prevalence most often reported to be between 25% and 45%. The most common type is stress urinary incontinence (SUI), defined as leakage upon exertion. First-line treatment includes pelvic floor muscle training (PFMT) and lifestyle advice. eHealth, the use of information and communication technology for health, can lower barriers to seeking help, save time and provide easily accessible care. In other conditions, the use of mobile technology has been argued to improve adherence to, and serve as a support for, self-management leading to improved symptom control.Aim: To evaluate self-management of urinary incontinence via eHealth with respect to clinically relevant improvement, treatment effect and factors associated with success. This thesis focuses on self-management of SUI via the mobile app Tät®.Methods: This thesis is based on four papers (I-IV) with data from three different studies (1-3). Studies 1 and 2 were randomised controlled trials, to which adult, community-dwelling women with at least weekly SUI were recruited via the website of the research project. In study 3, we studied the use of the Tät® app once it had been made freely available after study 2. All users with urinary incontinence that were 18 years of age or older were included. All interventions were developed within the research project, focused on PFMT and included lifestyle adviceIn study 1, participants were randomised to either internet-based or brochurebased SUI management. Data from both groups were analysed for correlation with the Patient Global Impression of Improvement (PGI-I) questionnaire and the changes in validated symptom (ICIQ-UI SF) questionnaire and in the quality of life (ICIQ-LUTSqol) questionnaire. We then determined a minimal important difference (MID) for non-face-to-face treatment of SUI. (Paper I)In study 2, participants were randomised to three months of self-management with the Tät® app or to control group (waiting list). The primary outcomes were ICIQ-UI SF and ICIQ-LUTSqol. These were analysed according to intention to treat using a linear mixed model. (Paper II) Data from the participants that were randomised to app management were analysed using logistic regression to identify factors associated with success. Success was defined as participants stating that they were much/very much better according to PGI-I. (Paper III)In study 3, users were asked to participate by completing questionnaires upon download of the app and three months thereafter. Background factors, PFMT iv frequency and app usage were analysed using logistic regression to identify factors associated with three outcomes: completion of three months of selfmanagement, improvement (according to PGI-I) and success (defined as described above). (Paper IV)Results: We found that the symptom and quality of life scores capture a clinically relevant improvement. The MIDs were determined to be a reduction of 2.52 points for ICIQ-UI SF and 3.71 points for ICIQ-LUTSqol. (Paper I)The Tät® app had a positive effect on symptoms with a mean ICIQ-UI SF reduction of 3.9 points (95% CI 3.0 -4.7), and improved quality of life with a mean ICIQ-LUTSqol reduction of 4.8 points (95% CI 3.4-6.2). These scores differed significantly from the control group and were well above the MIDs, and therefore clinically relevant improvements. Women in the intervention groups also had a greater decrease in incontinence episode frequency, and significantly reduced their pad use compared to the control group. In terms of patient satisfaction, 97% found the app to be “good” or “very good”. (Paper II)After three months of self-management with Tät®, 34 out of 61 participants (56%) stated that they were much or very much better. Three factors were associated with successful management: high expectations on treatment, weight control and self-assessed improvement in pelvic floor muscle strength. (Paper III)Once the app was freely available, 1 861 of 13 257 users (14%) completed the three-month follow-up. Four factors predicted completion: age, higher educational level, stress-type incontinence episodes and language. Together these factors accounted for 2.7% of the variability (Nagelkerke R2). Among the users that completed self-management, 68% improved and 29% were successful according to the PGI-I. Stress-type leakage and language were also associated with improvement. At least weekly PFMT and app usage predicted both improvement and successful self-management. (Paper IV)Conclusion: Self-management for urinary incontinence via a mobile app has clinically relevant effects on symptoms and quality of life. This is particularly the case for women with high expectations on app self-management and for those who used the app and exercised their pelvic floor at least weekly. Furthermore, beyond the study setting once the app was freely available, the majority of users’ symptoms improved if users completed three months of training.