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AIMS: To evaluate the effect of a mobile app treatment for stress urinary incontinence (SUI) in women.

METHODS: Randomized controlled trial, conducted 2013-2014 in Sweden. Community-dwelling adult women with ≥1 SUI episode/week recruited through our website and randomized to app treatment (n = 62) or control group (postponed treatment, n = 61). One participant from each group was lost to follow-up. Intervention was the mobile app Tät(®) with a treatment program focused on pelvic floor muscle training (PFMT), and information about SUI and lifestyle factors. Primary outcomes, 3 months after randomization: symptom severity (International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form [ICIQ-UI SF]); and condition-specific quality of life (ICIQ Lower Urinary Tract Symptoms Quality of Life [ICIQ-LUTSqol]).

RESULTS: One hundred and twenty-three women were included (mean age 44.7), with moderate/severe SUI (97.5%, 120/123), mean ICIQ-UI SF score 11.1 (SD 2.8) and mean ICIQ-LUTSqol score 34.4 (SD 6.1) at baseline. At follow-up, the app group reported improvements in symptom severity (mean ICIQ-UI SF score reduction: 3.9, 95% confidence interval 3.0-4.7) and condition-specific quality of life (mean ICIQ-LUTSqol score reduction: 4.8, 3.4-6.2) and the groups were significantly different (mean ICIQ-UI SF score difference: -3.2, -4.3to -2.1; mean ICIQ-LUTSqol score difference: -4.6, -7.8 to -1.4). In the app group, 98.4% (60/61) performed PFMT at follow-up, and 41.0% (25/61) performed it daily.

CONCLUSIONS: The mobile app treatment was effective for women with SUI and yielded clinically relevant improvements. This app may increase access to first-line treatment and adherence to PFMT.

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 advice

In 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.

Background: This study aimed to evaluate clinically relevant improvement after conservative self-management of urinary incontinence via a mobile app. It further aimed to establish Minimum Important Differences (MIDs) based on the severity and type of urinary incontinence.

Methods: Data was collected in a prospective cohort study that evaluated the freely available app Tät®. The app provided pelvic floor muscle training (PFMT) and life-style advice. Non-pregnant, non-postpartum women (≥ 18 years) who downloaded the app to treat urinary incontinence were included, if they completed the Patient Global Impression of Improvement (PGI-I) question at the 3-month follow-up (n = 1,733). Participants answered the International Consultation on Incontinence Questionnaire (ICIQ-UI SF) at baseline and after 3 months. The score change was analysed for correlation (Spearman) with the PGI-I. We then analysed one-way ANOVAs to determine whether there were significant differences between the groups based on the answers to the PGI-I. The MID was set to the mean change of the group that selected the answer “a little better” to the PGI-I question.

Results: The one-way ANOVA showed significant differences between PGI-I groups (p < 0.001). The MID for the general group was set to 1.46 (95% Confidence Interval [CI] 1.26–1.67). In the sub-group analyses, a MID for the group with slight incontinence could not be determined. For the group with moderate severity the MID was determined to be 1.33 (95% CI 1.10–1.57) and for the severe/very severe group it was 3.58 (95% CI 3.08–4.09). Analysis of different types of incontinence showed no difference in MIDs.

Conclusions: The MID for self-management via a mobile app was lower than previously established MIDs, but differed depending on baseline severity. This study shows that MIDs need adjustment for baseline severity and treatment intensity when interpreting clinical trial results. If using MIDs as exact numbers, the study population and the treatment must be comparable.

Introduction and hypothesis: Stress urinary incontinence is common among women. First-line treatment includes pelvic floor muscle training (PFMT) and lifestyle advice, which can be provided via a mobile app. The efficacy of app-based treatment has been demonstrated in a randomized controlled trial (RCT). In this study, we aimed to analyze factors associated with successful treatment.

Methods: Secondary analysis of data from the RCT. At baseline and 3-month follow-up, participants (n = 61) answered questions about symptoms, quality of life, background, and PFMT. Success was defined as rating the condition as much or very much better according to the validated Patient Global Impression of Improvement questionnaire. Factors possibly associated with success were analyzed with univariate logistic regression; if p < 0.20, the factor was entered into a multivariate model that was adjusted for age. Variables were then removed stepwise.

Results: At follow-up, 34 out of 61 (56%) of participants stated that their condition was much or very much better. Three factors were significantly associated with success: higher expectations for treatment (odds ratio [OR] 11.38, 95% confidence interval [CI] 2.02-64.19), weight control (OR 0.44 per kg gained, 95% CI 0.25-0.79), and self-rated improvement of pelvic floor muscle strength (OR 35.54, 95% CI 4.96-254.61). Together, these factors accounted for 61.4% (Nagelkerke R-2) of the variability in success.

Conclusion: These results indicate that app-based treatment effects are better in women who are interested in and have high expectations of such treatment. Also, the findings underline the importance of strengthening the pelvic floor muscles and offering lifestyle advice.

AIMS: To determine whether changes in questionnaire scores on symptoms and condition-specific quality of life reflect clinically relevant improvements in women with stress urinary incontinence (SUI).

METHODS: We retrospectively analyzed questionnaires collected during a randomized controlled trial in women with SUI, that received pelvic floor muscle training (PFMT) in two different formats. We included 218 women that answered validated self-assessment questionnaires at baseline and at a 4-month follow-up. We registered changes on two questionnaires, the International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) and the Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol). We compared these score changes to responses from the Patient Global Impression of Improvement (PGI-I) questionnaire. Differences were analyzed with the Spearman rho and one-way-ANOVA. The minimum important difference (MID) was the mean change in score for women that experienced a small improvement.

RESULTS: The PGI-I correlated significantly to both the ICIQ-UI SF (r = 0.547, P < 0.0001) and ICIQ-LUTSqol (r = 0.520, P < 0.0001). Thus, larger reductions in symptoms or quality of life scores were associated with greater impressions of improvement. The changes in ICIQ-UI SF and ICIQ-LUTSqol scores were significant across all PGI-I groups from "no change" to "very much improved" (P < 0.05). The MIDs were 2.52 (SD 2.56) for ICIQ-UI SF and 3.71 (SD 4.95) for ICIQ-LUTSqol.

CONCLUSIONS: The change in ICIQ-UI SF and ICIQ-LUTSqol scores after PFMT reflected clinically relevant improvements in women with SUI. The MIDs established for this population may facilitate future research, treatment evaluations, and comparisons between studies. 

Background: Pelvic floor muscle training (PFMT) is first-line treatment for urinary incontinence (UI) in women. Self-management via a mobile app is a new cost-effective method for PFMT delivery. This study analyzes factors associated with improvement among app users.

Methods: A pragmatic observational study in a community setting. Upon downloading the app Tät®, users answered questions regarding their age, education, residence, and UI symptoms. After 3 months, users answered follow-up questions regarding symptoms and frequency of training and app usage, and the validated Patient Global Impression of Improvement (PGI-I) questionnaire. Only non-pregnant, non-postpartum adult women with UI who answered the PGI-I questionnaire were included. Multivariate logistic regression was used to analyze possible associations between these factors with any improvement and with great improvement according to the PGI-I. The models were adjusted for age.

Results: The study included 2,153 participants who had completed self-management, that is, 11.5% of eligible women who completed the baseline questionnaire. Of these participants, 65.6% reported improvement of UI. Any improvement was associated with age, frequency of PFMT, and app use, accounting for 27.9% of variability (Nagelkerke R2). Lower incontinence severity, frequency of PFMT, and app use were associated with great improvement.

Conclusion: Self-management of urinary incontinence is easily accessible to many women and improvement rates are comparable with other forms of PFMT. Demographic factors and incontinence severity showed no or incongruent association, whereas regular PFMT and app use predicted any and great improvement. App use showed an additional effect beyond frequency of training.

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.

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.

Purpose: App-based treatment of urgency (UUI) and mixed (MUI) urinary incontinence has proved to be effective. To further improve treatment, it will be beneficial to analyze baseline and treatment-related factors that are associated with satisfaction.

Methods: A secondary analysis was conducted of data from a randomized controlled trial (RCT) assessing an app for UUI or MUI treatment, encompassing 98 women for whom there was long-term treatment satisfaction data. All participants completed a short-term (15 weeks) and a long-term (15 months) follow-up questionnaire after being given access to treatment. The outcome was a 3-item question on current treatment satisfaction at the long-term follow-up. Factors potentially associated with the outcome were analyzed using the chi-square test, Student’s t test or logistic regression.

Results: At the long-term follow-up, 58% of the women were satisfied with the treatment. The most important baseline variable associated with satisfaction was incontinence-related quality of life (International Consultation on Incontinence Questionnaire (ICIQ) − Lower Urinary Tract Symptoms Quality of Life Module) (OR 0.91, 95% CI 0.58–0.97). Short-term follow-up variables associated with long-term treatment satisfaction were improvement in the ability to endure urgency (OR 4.33, 95% CI 1.43–13.12), and confidence in pelvic floor contraction ability (OR 2.67, 95% CI 1.04–6.82).

Conclusion: App-based treatment for UUI and MUI may be an alternative first-line treatment that is satisfactory to many women over the long-term. Furthermore, short-term treatment that focuses on improving the ability to endure urgency, and confidence in pelvic floor contraction ability, can also be recommended for long-term satisfaction.