Cost-effectiveness of an app-based treatment for urinary incontinence in comparison with care-as-usual in Dutch general practice: a pragmatic randomised controlled trial over 12 months.

OBJECTIVE: To assess the cost-effectiveness of app-based treatment for female stress, urgency or mixed urinary incontinence (UI) compared with care-as-usual in Dutch primary care. DESIGN: A pragmatic, randomised controlled, superiority trial. SETTING: Primary care in the Netherlands from 2015 to 2018, follow-up at 12 months. POPULATION: Women with ≥2 UI-episodes per week, access to mobile apps, wanting treatment. METHODS: The standalone app included conservative management for UI with motivation aids (e.g. reminders). Care-as-usual delivered according to the Dutch GP guideline for UI. MAIN OUTCOME MEASURES: Costs and cost-effectiveness and -utility were assessed from a societal perspective, based on incontinence impact adjusted life years (IIALYs), quality adjusted life years (QALYs) and medical, non-medical and productivity costs. Information on costs was obtained with the iMCQ and iPCQ questionnaires (medical consumption and productivity cost questionnaires). RESULTS: In all, 262 women were andomised equally to app or care-as-usual; 89 (68%) and 83 (63%) attended follow-up, respectively. Costs were lower for app-based treatment with € -161 (95% confidence interval [CI -180 to -151) per year. Cost-effectiveness showed small mean differences in effect for IIALY (0.04) and QALY (-0.03) and thus larger incremental cost-effectiveness ratios (ICER: -€3696) and incremental cost-utility ratios (ICUR: €6379). CONCLUSION: App-based treatment is a cost-effective alternative to care-as-usual for women with UI in Dutch primary care. TWEETABLE ABSTRACT: App-treatment for female urinary incontinence cost-effective compared to care-as-usual in general practice after 12 months.

Barriers and Facilitators Associated With App-Based Treatment for Female Urinary Incontinence: Mixed Methods Evaluation.

BACKGROUND: App-based treatment for urinary incontinence is a proven effective and cost-effective alternative to care as usual, but successful implementation requires that we identify and address the barriers and facilitators associated with app use. OBJECTIVE: The goal of the research was to explore the factors influencing app-based treatment for urinary incontinence and identify which barriers or facilitators are associated with treatment success or failure. METHODS: We used a sequential explanatory mixed methods design to connect the results of a randomized controlled trial with data from semistructured interviews. This previous RCT had shown the noninferiority of app-based treatment compared with care as usual for urinary incontinence over 4 months. Participants who reported success or failure with app-based treatment, as measured by the change in International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form symptom score, were selected for telephone interview by purposive sampling (n=17). This study reports mainly on the qualitative component of our mixed methods study. Qualitative analyses were conducted in two ways. First, we analyzed the qualitative data of all interviewed participants and discussed the relationships between the main themes. Second, the experiences between the success (n=9) and failure group (n=8) were compared and contrasted to explore factors that were positively or negatively associated with the quantitative effect of app-based treatment. These factors were then interpreted as barriers to and facilitators of successful app-based treatment. RESULTS: Four interrelated themes were identified as affecting the app based treatment effect: adherence, personal factors, app factors, and awareness. Qualitative analyses of the relationships between the themes showed that adherence-related factors directly influenced treatment effect in both a positive and negative matter. In turn, adherence was also positively and negatively influenced by the other 3 themes. Additionally, awareness was positively influenced by the treatment effect. Within these themes, several factors were identified that acted as barriers (eg, unrealistic expectation of time investment and interfering personal circumstances), facilitators (eg, strict integration of exercises and prior pelvic floor muscle therapy), or both (eg, personality traits and increased awareness of symptoms). CONCLUSIONS: This study shows that the effect of app-based treatment for urinary incontinence is mainly influenced by adherence, which in turn is affected by personal factors, app-based factors, and awareness. The identified factors could function as both facilitators and barriers depending on the user and interaction with other themes. Insight into these facilitators and barriers could lead to improved implementation and increased treatment effectiveness by targeting women most likely to benefit and through further development of the app. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1002/nau.23507.

App-Based Treatment in Primary Care for Urinary Incontinence: A Pragmatic, Randomized Controlled Trial.

PURPOSE: Electronic application (app)-based treatment is promising for common diseases with good conservative management options, such as urinary incontinence (UI) in women, but its effectiveness compared with usual care is unclear. This study set out to determine if app-based treatment for women with stress, urgency, or mixed UI was noninferior to usual care in the primary care setting. METHODS: The URinControl trial is a pragmatic, noninferiority randomized controlled trial in Dutch primary care including adult women with 2 episodes of UI per week. From July 2015 to July 2018, we screened 350 women for eligibility. A stand-alone app-based treatment with pelvic floor muscle and bladder training (URinControl) was compared with usual care according to the Dutch general practitioner guideline for UI treatment. Outcomes measured were change in symptom severity score from baseline to 4 months (primary outcome), impact on disease-specific quality of life, patient-perceived improvement, and number of UI episodes. Noninferiority (<1.5 points) was assessed with linear regression analysis. RESULTS: A total of 262 eligible women were randomized equally; 195 of them had follow-up through 4 months. The change in symptom severity with app-based treatment (-2.16 points; 95% CI, -2.67 to -1.65) was noninferior to that with usual care (-2.56 points; 95% CI, -3.28 to -1.84), with a mean difference of 0.058 points (95% CI, -0.776 to 0.891) between groups. Neither treatment was superior to the other, and both groups showed improvements in outcome measures after treatment. CONCLUSIONS: App-based treatment for women with UI was at least as effective as usual care in the primary care setting. As such, app-based treatments, with their potential advantages of privacy, accessibility, and lower cost, may provide women with a good alternative to consultation.

User Experiences and Preferences Regarding an App for the Treatment of Urinary Incontinence in Adult Women: Qualitative Study.

BACKGROUND: Although several apps are available to support the treatment of urinary incontinence (UI), little has been reported about the experiences and preferences of their users. OBJECTIVE: The objective of this study was to explore the experiences and preferences of women using a mobile app for the treatment of UI and to identify potential improvements to the app. We developed this app for three types of UI: stress UI, urgency UI, and mixed UI. METHODS: The participants in this qualitative study were women with self-reported stress UI, urgency UI, or mixed UI who used an app-based treatment to manage their condition for at least six weeks. Following the intervention, semistructured interviews were conducted to explore the participants' experiences and preferences regarding the app. All interviews were audio-recorded, transcribed verbatim, and analyzed separately by two researchers. RESULTS: Data saturation was reached after interviewing 9 women (aged 32-68 years) with stress UI (n=1, 11%), urgency UI (n=3, 33%), or mixed UI (n=5, 56%). Accessibility, awareness, usability, and adherence emerged as the main themes. On the one hand, participants appreciated that the app increased their accessibility to care, preserved their privacy, increased their awareness of therapeutic options, was easy to use and useful, and supported treatment adherence. On the other hand, some participants reported that they wanted more contact with a care provider, and others reported that using the app increased their awareness of symptoms. CONCLUSIONS: This qualitative study indicates that women appreciate app-based treatment for UI because it can lower barriers to treatment and increase both awareness and adherence to treatment. However, the app does not offer the ability of face-to-face contact and can lead to a greater focus on symptoms.

Recruitment through media and general practitioners resulted in comparable samples in an RCT on incontinence.

OBJECTIVES: The objective of the study was to assess the impact of recruitment strategy on the baseline characteristics of patients recruited in a randomized controlled trial for treating women with urinary incontinence. STUDY DESIGN AND SETTING: We conducted a cross-sectional analysis of baseline data from an earlier trial. Women were recruited through the media (including social media) or from participating general practices. Baseline characteristics were compared by univariate testing. Logistic regression analysis was performed to study the association between recruitment type and multiple baseline characteristics. RESULTS: The only differences between recruitment methods were in patient age, with those recruited through the media being significantly older than those recruited through general practice. The mean age difference was 5.0 years (95% confidence interval: 2.2-7.9). CONCLUSION: Samples recruited through the media and through case identification were largely comparable. Therefore, recruitment through the media may be a viable alternative to recruitment through primary care. This may be especially relevant for research on eHealth treatment for conditions with which patients experience barriers when seeking health care.

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.

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.