Background Many women experience urgency (UUI) and mixed (MUI) urinary incontinence but commonly hesitate to seek care. Treatment access and self-management for these conditions can be supported through eHealth approaches. Objective This study aimed to investigate the efficacy of the mobile app Tät II for self-management of UUI and MUI in women. Methods This randomized controlled trial included women ≥18 years old with UUI or MUI and ≥2 leakages per week. Those with red-flag symptoms were excluded. Participants were recruited via analog and digital advertisements and screened for initial selection through a web-based questionnaire. Data were collected using another questionnaire and a 2-day bladder diary. A telephone interview confirmed the symptom diagnosis. Participants were randomized (1:1) to receive access to a treatment app (including pelvic floor muscle training, bladder training, psychoeducation, lifestyle advice, tailored advice, exercise log, reinforcement messages, and reminders) or an information app (control group), with no external treatment guidance provided. The primary outcome was incontinence symptoms at the 15-week follow-up, measured using the International Consultation on Incontinence Questionnaire (ICIQ)−Urinary Incontinence Short Form (ICIQ-UI SF). Urgency symptoms were assessed using the ICIQ−Overactive Bladder Module (ICIQ-OAB) and quality of life using the ICIQ−Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol). Incontinence episode frequency (IEF) was calculated per bladder diary entries. Improvement was measured using the Patient’s Global Impression of Improvement. All outcomes were self-reported. Cure was defined as no leakages per the bladder diary. Intention-to-treat analysis was performed. Results Between April 2017 and March 2018, 123 women (mean age 58.3, SD 9.6 years) were randomized to the treatment (n=60, 2 lost to follow-up) or information (n=63) group. Of these, 35 (28%) women had UUI, and 88 (72%) had MUI. Mean ICIQ-UI SF score at follow-up was lower in the treatment group than in the information group (estimated difference −3.1, 95% CI −4.8 to −1.3). The estimated between-group difference was −1.8 (95% CI −2.8 to −0.99) for mean ICIQ-OAB score and −6.3 (95% CI −10.5 to −2.1) for the mean ICIQ-LUTSqol score at follow-up. IEF reduction from baseline to follow-up was greater in the treatment group (−10.5, IQR −17.5 to −3.5) than in the information group (P<.001). Improvement was reported by 87% (52/60) of treatment group participants and by 30% (19/63) of information group participants. The cure rate was 32% in the treatment group, and 6% in the information group (odds ratio 5.4, 95% CI 1.9-15.6; P=.002). About 67% (40/60) of the treatment group participants used the app more than thrice a week. Conclusions The treatment app was effective for improving urgency and mixed incontinence in women. When self-management is appropriate, this app may be a good alternative to pharmacological treatment or other conservative management, thus increasing access to care. Trial Registration ClinicalTrials.gov NCT03097549; https://clinicaltrials.gov/ct2/show/NCT03097549

Aims To evaluate the long‐term effect of the Tät®II app for treatment of urgency (UUI) and mixed urinary incontinence (MUI). Methods Long‐term follow‐up of a randomized controlled trial, including 123 women ≥18 years old with UUI or MUI, without red‐flag symptoms, and ≥2 leakages per week. All participants, regardless of group, had received the intervention, a treatment app, at the long‐term follow‐up. Long‐term data were collected through web‐based questionnaires 15 months after participants received the intervention. The app included pelvic floor muscle training, bladder training, psychoeducation, lifestyle advice, an exercise log, reminders, reinforcement messages, and tailored advice. The primary outcome was a change in incontinence symptoms (International Consultation on Incontinence Questionnaire [ICIQ]—Urinary Incontinence Short Form [ICIQ‐UI SF]), from baseline to follow‐up. Other outcomes were urgency symptoms (ICIQ—Overactive Bladder Module (ICIQ‐OAB)), quality of life (ICIQ—Lower Urinary Tract Symptoms Quality of Life Module [ICIQ‐LUTSqol]), and improvement (Patient's Global Impression of Improvement [PGI‐I]). Results Of the 123 women, 102 (83%) completed the long‐term follow‐up. The ICIQ‐UI SF mean score improved from 11.5 to 7.6 (mean difference 4.0, 95% CI 3.2–4.7). The ICIQ‐OAB improved from 6.7 to 5.5 (mean difference 1.3, 95% CI 0.9–1.6) and the ICIQ‐LUTSqol improved from 38.0 to 30.9 (mean difference 7.1, 95% CI 5.7–8.5). Of the 102 women, 74 (73%) reported improvement. Conclusions Self‐management with the Tät®II app for UUI and MUI had a significant effect across all outcome measures also long‐term and might serve as an alternative first‐line treatment for these conditions.

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BACKGROUND Many women experience urgency and mixed urinary incontinence, but commonly hesitate to seek care. Treatment access and self-management can be supported through eHealth methods. OBJECTIVE This study investigated the efficacy of a mobile app for self-management of urgency and mixed urinary incontinence. METHODS This randomised controlled trial was conducted in Sweden. We included women of ≥18 year old, with urgency or mixed urinary incontinence and ≥2 leakages/week, excluding those with alarm symptoms. The women were recruited via information on TV, radio, and newspapers, and via Facebook advertisements. Initial selection was performed using a web-based screening questionnaire at our webpage. Data was then collected using an inclusion questionnaire and a two-day bladder diary. Symptom diagnosis was confirmed through a telephone interview. Participants were randomised to a treatment app (pelvic floor muscle training, bladder training, psychology, lifestyle advice, individual advice, statistics, reinforcement messages, and reminders) or brief information app (control). No guidance on the treatment was provided outside of the apps. The primary outcome was incontinence symptoms at follow-up (15 weeks), measured by ICIQ-UI SF score. Urgency symptoms were assessed via ICIQ-OAB score, and quality of life via ICIQ-LUTSqol score. Improvement was measured using Patient’s Global Impression of Improvement (PGI-I). These outcomes were patient reported. Cure was defined as no leakages (based on bladder diary). Intention-to-treat analysis was performed. RESULTS Between April 2017 and March 2018, 123 women were randomised to treatment (n=60, two lost to follow-up) or information (n=63). Of the included women, 28% had symptoms of urgency urinary incontinence, and 72% had mixed urinary incontinence. The mean age was 58.3 (SD 9.6) years and the majority had a university education. Half of the women were overweight or obese. Baseline characteristics did not differ between the two groups. The mean follow-up ICIQ-UI SF score was lower in the treatment group than the information group (estimated difference 3.1; 95% CI −4.8 to −1.3). For the follow-up ICIQ-OAB score, the estimated between-groups difference was −1∙8 (95% CI −2∙8 to −0∙99) and for the ICIQ-LUTSqol, the estimated between-groups difference was -6.3 (95% CI -10.5 to -2.1). Of women in the treatment group 90% reported an improvement, compared to 30% in the information group. Cure was reported by 19 women in the treatment group, and 4 in the control group (OR 5.38, 95% CI 1.86 to 15.57, p=0.002). During the 15-week treatment period, 69% of women in the treatment group used the app daily, and 10% used it at least three times per day. CONCLUSIONS The tested treatment app was effective for improvement and cure of urgency and mixed incontinence in women. It may be a good alternative to pharmacological treatment or other conservative management, increasing access to care. CLINICALTRIAL ClinicalTrials.gov NCT03097549