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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 (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.

OBJECTIVE: To assess the long-term effectiveness of app-based treatment for female stress, urgency, or mixed urinary incontinence (UI) compared to care-as-usual in 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. 262 women randomised equally to app or care-as-usual; 89 (68%) and 83 (63%) attended one year follow-up.INTERVENTIONS: 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: Effectiveness assessed by the change in symptom severity score (ICIQ-UI-SF) and the change in quality of life (ICIQ-LUTS-QoL) with linear regression on an intention-to-treat basis.RESULTS: Clinically relevant improvement of UI severity for both app (-2.17 ± 2.81) and care-as-usual (-3.43 ± 3.6), with a non-significant mean difference of 0.903 (-0.66 to 1.871).CONCLUSION: App-based treatment is a viable alternative to care-as-usual for UI in primary care in terms of effectiveness after one year.

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

AIMS: An increasing number of diagnostic and therapeutic medical devices are available to help patients and physicians manage pelvic floor symptoms in women. Many of these are presented at scientific conferences, and in the absence of a gold standard for evaluation, marketing has become more prominent than scientific evaluation. The goal of this study was to (a) provide an overview of pelvic floor devices for women that have been presented at recent annual meetings of leading scientific societies and (b) to summarize and review the scientific evidence underpinning these devices.METHODS: Manual searches were performed of all abstracts presented in 2016 and 2017 at annual meetings of the International Continence Society, the International Urogynecological Association, the European Association of Urology, and the American Urological Association. The exhibition floor of the 2017 International Continence Society was also searched. Subsequently, literature searches of both the MEDLINE and Embase databases were performed in November 2018 to identify original full-text publications related to the identified devices.RESULTS: We identified 11 devices from these sources, which were mainly used for the control of urinary incontinence. Only seven of these pelvic floor devices were covered by publications, with no full-text records identified for the remaining four devices.CONCLUSIONS: Sample sizes were small and there was a lack of convincing evidence for most devices. Despite this, many devices were available in the market. Our findings indicate that the process for introducing these new devices is in stark contrast with the strict requirements for introducing new drug classes.

Objective: Long-term cost-effectiveness of app-based treatment for female stress, urgency, or mixed urinary incontinence (UI) compared to care-as-usual in 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. 262 women randomised equally to app or care-as-usual; 89 (68%) and 83 (63%) attended follow-up. 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: Effectiveness assessed by the change in symptom severity score (ICIQ-UI-SF) and the change in quality of life (ICIQ-LUTS-QoL, EQ-5D-5L) on superiority with linear regression on an intention-to-treat basis. Cost-effectiveness and -utility from a societal perspective, based on Incontinence Impact Adjusted Life Years (IIALYs) and Quality Adjusted Life years (QALYs). Results: Clinically relevant improvement of UI severity for both app (-2.17 ± 2.81) and care-as-usual (-3.43 ± 3.6), with a non-significant mean difference of 0.903 (-0.66 to 1.871). Costs were lower for app-based treatment with \euro-161 (95%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 ICER (-3,696) and ICUR (\euro6,379). Conclusion: App-based treatment is a viable alternative to care-as-usual for UI in primary care in terms of long-term cost-effectiveness. Funding: Dutch Organisation for Health Research and Development (ZonMw: 837001508), sub-funding P.W. Boer Foundation Dutch Trial Register identifier: Trial NL4948 (www.trialregister.nl/trial/4948).

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.

HYPOTHESIS/AIMS OF STUDY: Over 100 apps for urinary incontinence are available in the app store and google play, but evidence on their effective-ness is scarce. Available studies focused on the treatment of stress urinary incontinence only (1). Mobile applications may support women with urinary continence, but it is unclear if the effect of such treatment equals care as usual. In many countries, general practitioners (GPs) provide frst line treatment of urinary incontinence. We studied if the effectiveness of an app-based treatment for stress-urgency-and mixed urinary incontinence is non-inferior to care as usual provided by GPs after 4 months. To assess the beneft of an app in real clinical practice, we chose a non-inferiority comparison to care as usual. STUDY DESIGN, MATERIALS AND METHODS: This trial was a pragmatic, block-randomized, two arm, parallel, non-inferiority design with participants receiving app-based treatment or care as usual for stress-, urgency-or mixed urinary incontinence (UI). We recruited participants through primary care practices, lay press and social media. Adult woman, with ≥ 2 urinary incontinence episodes per week, with access to a smartphone or tablet and willing to receive treatment were eligible. We excluded woman with conditions possibly related to stress-, urgency-or mixed incontinence, those who had previous surgery for incontinence or any other treatment for incontinence in the previous year, or those that were unable to complete a questionnaire in Dutch or had a terminal or mental illness. Participants signed an informed consent form before entering the study. The app contains a step-by-step program for the self-management of urinary incontinence. The app ofered information on incontinence and lifestyle advices, exercises focusing on awareness of the pelvic foor muscle and exercises to train the pelvic foor muscle and/or bladder. The type of incontinence directed treatment advices. Care as usual consisted of any or more of the following: instructions on pelvic foor muscle and/or bladder training; prescribing a pessary, drugs, or absorbent products; or referral to a continence nurse, a pelvic physiotherapist, or to secondary care. After inclusion and baseline assessment, the randomization was carried out using the validated web-based computer program ALEA to ensure full allocation concealment. The primary outcome was diference in change in urinary incontinence severity (assessed with the ICIQ-UI-short form) from baseline to 4 months. We used linear regression to compare the change of ICIQ-UI-SF symptom score between groups, in a per-protocol analysis, which is the most conservative for the non-inferiority design. For this, we included women from the app-group that logged in in the app at least once and women from the care as usual group that visited their GP for incontinence at least once. The non-inferiority margin is set at 1.5 points diference of change in UI severity between groups. This is based on the 1.58 points between-treatment minimum important difer-ence in change (MID) for the ICIQ-UI-SF, previously identifed among participants with stress UI (2). Assuming a power of 0.80 with a one-sided type I error of 0.025, we needed a sample of 100 evaluable participants per group. RESULTS: Participants were recruited through 88 GPs (n=201) and through (social) media (n=149). Of 350 participants screened, 262 were eligible and randomly allocated to either App-based treatment (n=131) or care as usual (n=131). The mean age of included women was 53 years (range 20-86), median duration of incontinence was 7 years (Interquartile range 4-14). Fifty percent of participants reported a mixed type of incontinence, 42% stress incontinence and 8% urgency incontinence.The incontinence severity was slight (10%) moderate (64%) or severe (26%). The per-protocol analysis included 96 (app-group) and 75 participants (care as usual). Both groups showed improvement after treatment with a mean change in incontinence severity of-2.15 (SD 2.56) points in the app group and-2.75 (3.62) points in the care as usual group. The mean diference of change of incontinence severity between both groups was 0.071 points (95% CI:-0.837 to 0.979), which did not reach the pre-specifed boundary of 1.5 points but did cross zero (Figure1). This means that the app-based treatment effect was non-inferior to the care as usual treatment effect, but not superior. INTERPRETATION OF RESULTS: This RCT shows that an app-based treatment for woman with stress-, urgency and mixed urinary incontinence is at least as effective as the best current treatment provided by GPs at 4 months. This is the frst study with a pragmatic comparison of an app-based treatment for urinary incontinence to care as usual and we believe our results provide a realistic reffec-tion of the treatment effect in a real life setting. Symptom improvement shown was clinically relevant in both groups. The three main types of incontinence can be treated by the same app, therefore increasing the applicability and relevance of app treatment. CONCLUDING MESSAGE: This is the frst study on an app-based treatment for women with stress-, urgency-, and mixed UI, showing that it is non-inferior compared to care as usual in primary care after 4 months. Further research is needed to study long-term effectiveness, and the cost-effectiveness of app-based treatment, and to understand the process underlying treatment success.

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.