A Mobile App for Self-management of Urgency and Mixed Urinary Incontinence in Women: Randomized Controlled Trial

Abstract

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

Quality of life in women with urinary incontinence seeking care using e-health

“…For all three RCTs, there was no face-to-face contact between the study participants, researchers, and healthcare providers throughout the recruitment and treatment processes. Treatment effectiveness was evaluated in the short term (three months) [ 17 – 19 ] and over the long term (up to two years) [ 20 , 21 ]. Previous studies found that UI treatments that focused mainly on PFMT, provided via the internet or a mobile app, showed clinically relevant improvements in symptoms and in QoL [ 17 – 21 ].…”

“…The enrolment process and the inclusion and exclusion criteria for the three RCTs are shown In Table 1 . More detailed data were published previously [ 17 – 19 ].…”

Quality of Life in Women with Urinary Incontinence Seeking Care Using E-Health

“…Community-dwelling women were recruited from all over Sweden, via the project's website (www.tät.nu), and throughout the process there was no face-to-face contact between the study participants, researchers, and healthcare providers in any of the three RCTs. The treatments have been evaluated with regard to effectiveness in the short (three months) [17][18][19] and long (up to two years) term. [20,21] UI treatment focusing on mainly PFMT, provided via internet or a mobile app, showed clinically relevant symptom improvement as well as improvement in QoL.…”

“…[20,21] UI treatment focusing on mainly PFMT, provided via internet or a mobile app, showed clinically relevant symptom improvement as well as improvement in QoL. [17][18][19][20][21] In Table 1, enrolment process information and inclusion and exclusion criteria for the three RCTs can be found. Further information is also available in the original articles.…”

“…Further information is also available in the original articles. [17][18][19] Table 1 Overall information, inclusion and exclusion criteria, and enrolment process, in three randomized studies for women with urinary incontinence (UI) using e-health.…”