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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.

Background and Aims: Pelvic floor muscle training (PFMT) is recommended for continent pregnant women and postnatal women experiencing urinary incontinence (UI). The app Tät® has been developed for the treatment of stress UI with a focus on PFMT. The aim of this study was to investigate factors associated with the improvement of incontinence symptoms and retained continence in pregnant and postnatal women who used the app.

Methods: A prospective cohort study was carried out based on user questionnaires from the app Tät®. We included pregnant and postnatal women who answered the inclusion questionnaire between June 19, 2019 and September 19, 2020. The questionnaire included questions about the frequency and amount of leakage, the impact that UI has on everyday life, and experienced improvements at follow-up. We analyzed factors associated with improvement and retained continence using logistic regression.

Results: We included 10,307 pregnant and 13,670 postnatal women, and 44% of the pregnant women and 52% of the postnatal women were incontinent. A total of 3680 women were included in the follow-up analysis, and 52% of the pregnant incontinent women and 73% of the postnatal incontinent women experienced improvement. Pregnant women who performed PFMT and used the app at least once per week had increased odds of improvement (odds ratio [OR]: 1.83, 95% confidence interval [CI]: 1.01–3.29 and OR: 3.38, 95% CI: 1.94–5.90, respectively) compared to those who performed no training and had no app usage. Postnatal women who used the app at least once per week and had more severe incontinence had increased odds of improvement (OR: 4.26, 95% CI: 2.37–7.64 and OR: 1.11, 95% CI: 1.05–1.16, respectively).

Conclusions: The app Tät® is widely used by pregnant and postnatal women in Sweden for the prevention and treatment of UI. Majority of the women with incontinence experienced improvement after using the app. Regular PFMT and app use seemed to be important factors for experiencing improvement.

Background: Quality of life (QoL) in women with urinary incontinence (UI) is mainly affected by UI severity, but it is also affected by the UI subtype, comorbidities, age, and socioeconomic status. e-Health is a new method for providing UI treatment. This study aimed to identify factors with the highest impact on QoL in women that turned to e-health for UI self-management.

Methods: We analysed data from three randomized controlled trials (RCTs) that evaluated e-health treatments for UI. We included baseline data for 373 women with stress urinary incontinence (SUI) and 123 women with urgency/mixed UI (UUI/MUI). All participants were recruited online, with no face-to-face contact. Participants completed two questionnaires: the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF, range: 0–21 points), for assessing UI severity, and the ICIQ Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol, range: 19–76 points), for assessing condition-specific quality of life (QoL). To identify factors that impacted QoL, we constructed a linear regression model.

Results: The mean ICIQ-LUTSqol score was 34.9 (SD 7.6). UI severity significantly affected QoL; the adjusted mean ICIQ-LUTSqol score increased by 1.5 points for each 1.0-point increase in the overall ICIQ-UI SF score (p < 0.001). The UI type also significantly affected QoL; the adjusted mean ICIQ-LUTSqol score was 2.5 points higher in women with UUI/MUI compared to those with SUI (p < 0.001).

Conclusions: We found that women that turned to e-health for UI self-management advice had a reduced QoL, as shown previously among women seeking UI care through conventional avenues, and that the severity of leakage had a greater impact on QoL than the type of UI. Condition-specific factors impacted the QoL slightly less among women that turned to e-health, compared to women that sought help in ordinary care. Thus, e-health might have reached a new group of women in need of UI treatment.

Objectives: The efficacy of app-based treatment for stress urinary incontinence (SUI) has been demonstrated in a randomised controlled trial (RCT). In this study, we investigate the user characteristics and the effectiveness of the same app when freely available, and compare these results with the RCT.

Design: Prospective cohort study.

Participants: During a 17-month period, 24 602 non-pregnant, non-postpartum women older than 18 years downloaded the app and responded anonymously to a questionnaire. Of these, 2672 (11%) responded to the 3-month follow-up.

Intervention: Three months' use of the app Tat, containing information, a pelvic floor muscle training programme and lifestyle advice.

Main outcome measures: Change in symptom severity (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)) and subjective improvement (Patient Global Impression of Improvement (PGI-I)).

Results: Of the respondents, 88% lived in Sweden and 75% (18 384/24 602) were incontinent with a mean age of 45.5 (SD 14.1) years. The UI types, based on symptoms, were SUI (53%), urgency UI (12%), mixed UI (31%) and undefined (4%). The mean ICIQ-UI SF score was 8.2 (SD 4.0) at baseline. The mean ICIQ-UI SF score reduction at follow-up was 1.31 (95% CI: 1.19 to 1.44) with a larger reduction in those with more severe incontinence at baseline (severe/very severe 3.23 (95% CI: 2.85 to 3.61), moderate 1.41 (95% CI: 1.24 to 1.59) and slight 0.24 (95% CI 0.06 to 0.42). When the results were weighted to match the distribution of severity in the RCT, the ICIQ-UI SF score reduction was 2.2 compared with 3.9 in the RCT. Regarding PGI-I, 65% experienced improvement compared with 92% in the RCT.

Conclusions: The app Tat was effective for self-management of UI even in the real world. Although the reduction in incontinence symptoms was less than in the RCT, two-thirds of the users improved. App-based treatment reaches many women without requiring resources from ordinary healthcare services.

Background

Urinary incontinence affects 25-45% of all women. The most common type is stress urinary incontinence, which is the leakage of urine on physical exertion. Pelvic floor muscle training is an effective first-line treatment for this condition but many women do not seek help from their ordinary health care service. There is a need to evaluate new methods to offer effective treatment, and internet-based treatment has previously been found to be effective for women with stress urinary incontinence.

Aim

To evaluate the mobile app Tät® which has a self-management program focused on pelvic floor muscle training for women with stress urinary incontinence, with respect to treatment effect, factors associated with successful treatment, user experience and use by pregnant and postnatal women.

Methods

Papers I, II and III are based on the same study population from a randomized controlled trial (RCT). We recruited adult women who had stress urinary incontinence at least weekly via our website. In total, 123 women  were randomized to the app group (n=62) or the control group (n=61). The app included information about incontinence, the pelvic floor and lifestyle factors associated with incontinence, pelvic floor muscle training exercises and functions for reminders and training statistics. Treatment outcome after three months was evaluated using validated questionnaires assessing incontinence symptoms, quality of life, subjective improvement and a leakage diary. Outcomes were compared between the two groups. Factors associated with a successful outcome in the app group were further analysed using logistic regression. We strategically selected 15 women who had used the app and interviewed them about their experiences of using the app. The interviews were analysed according to Grounded Theory. After closing the RCT we made the app freely available and continued to follow its use on a larger scale by incorporating an anonymous questionnaire that appeared within the app upon download and after three months. The data from these questionnaires is used in paper IV. 

Results

Participants in the RCT had a mean age of 44.7 years (range 27-72) and 120 of the 123 women had moderate/severe incontinence. The app group reported significant improvements in the primary outcomes, the incontinence symptom score (mean ICIQ-UI SF reduction 3.9, 95% CI 3.0-4.7) and the quality of life score (mean ICIQ LUTSqol reduction 4.8, 95% CI 3.4-6.2), and the difference between the groups was significant. The app group also reduced their number of leakages and use of incontinence aids compared to the control group. At follow-up 92% of women in the app group experienced subjective improvement and 56% had improved “much” or “very much” and were classified as having a successful treatment outcome.

Factors associated with a successful outcome were higher expectations of treatment effect (OR 11.38, 95% CI 2.02-64.19), weight control (OR 0.44 per kg gained, 95% CI 0.24-0.79), and self-assessed improvement of pelvic floor muscle strength (OR 35.54, 95% CI 4.96-254.61).

The main finding from the interviews was that women experienced that the app “enabled their independence”. They described that the app was “something new” that helped with “keeping motivation up” although they sometimes wondered whether their training efforts were “good enough”.

The freely available app was downloaded by 10,456 pregnant and postnatal women during a period of ten months (41% of all users). At inclusion 51% experienced incontinence and their mean ICIQ-UI SF score was 6.7 (SD 3.45). After three months, 1,805 women answered the follow-up. The majority of women with incontinence at inclusion experienced improvement with greater improvement in the postnatal group than in the pregnant group.

Conclusion

The mobile app Tät® offers a new, easily accessible and effective self-management program for women with stress urinary incontinence. Women appreciated that the app enabled them to manage their pelvic floor muscle training independently. Once the app was freely released it reached a large population with many pregnant and postnatal women. We believe that the app could be useful for the prevention of urinary incontinence among pregnant women. We also believe that the app could be used both as a stand-alone treatment and as a complement to other treatments provided by the ordinary health care service.

Bakgrund

Urininkontinens är vanligt och drabbar ca 25–45% av alla kvinnor. Den vanligaste typen är ansträngningsinkontinens vilket innebär att man läcker urin i samband med fysisk aktivitet, hosta eller nysning. Bäckenbottenträning är en effektiv förstahandsbehandling, men många kvinnor söker inte hjälp för sin inkontinens inom vården. Det finns ett behov av att kunna erbjuda behandling på nya sätt för att nå fler kvinnor och ett internetbaserat behandlingsprogram har tidigare visat sig ha god effekt vid ansträngningsinkontinens.

Syfte

Att utvärdera appen Tät® som innehåller ett program för egenbehandling av ansträngningsinkontinens med fokus på bäckenbottenträning, med avseende på behandlingseffekt, framgångsfaktorer, upplevelse av behandling och användning bland gravida och nyförlösta kvinnor.

Metod        

Artiklarna I, II och III baseras på material från en randomiserad kontrollerad studie. Till studien bjöd vi in vuxna kvinnor med ansträngningsinkontinens och urinläckage åtminstone en gång per vecka via vår hemsida tät.nu. Vi randomiserade 123 kvinnor till antingen appgruppen (62 kvinnor) eller kontrollgruppen (61 kvinnor). Appen innehöll information om inkontinens och bäckenbotten, livsstilsfaktorer som kan påverka inkontinens, bäckenbottenövningar och funktioner för påminnelser och statistik. Behandlingseffekten utvärderades efter tre månader med hjälp av validerade frågeformulär avseende inkontinenssymtom, livskvalitet och upplevd förbättring samt antalet episoder av urinläckage. Resultaten jämfördes mellan grupperna. Faktorer som kunde vara associerade med ett lyckat behandlingsresultat analyserades med logistisk regression. Vi gjorde ett strategiskt urval av 15 kvinnor från appgruppen och intervjuade dem om deras upplevelse av att använda appen. Intervjuerna analyserades enligt metoden Grounded Theory. Efter att vi avslutat studien släppte vi appen fritt tillgänglig och fortsatte att följa användningen genom att lägga in ett anonymt frågeformulär som kom upp automatiskt i appen när man laddade ner den och sen igen efter tre månader. Artikel IV baseras på data från dessa frågeformulär.

Resultat

Medelåldern i den randomiserade kontrollerade studien var 44,7 år (27 till 72 år) och 120 av 123 kvinnor hade medelsvår eller svår inkontinens. Appgruppen förbättrades signifikant avseende de primära utfallsmåtten inkontinenssymtom (ICIQ-UI SF medelförbättring 3,9 poäng, 95 % KI 3,0 – 4,7) och livskvalitet (ICIQ-LUTSqol medelförbättring 4,8 poäng, 95 % KI: 3,4 – 6,2) och skillnaden mellan grupperna var signifikant. Appgruppen minskade också antalet episoder av läckage per vecka och användningen av inkontinensskydd jämfört med kontrollgruppen. Vid uppföljningen upplevde 92% i appgruppen att de var bättre och 56% upplevde att de var mycket eller väldigt mycket bättre och bedömdes ha ett lyckat behandlingsresultat. De faktorer som var associerade med ett lyckat behandlingsresultat var högre förväntningar på behandlingsresultatet, viktstabilitet och självskattad förbättring av bäckenbottenstyrkan.

Det viktigaste fyndet i intervjustudien var att kvinnorna upplevde att appen ”möjliggjorde deras självständighet”. De beskrev att appen var ”något nytt” som hjälpte dem att ”hålla motivationen uppe” trots att de ibland undrade över om bäckenbottenträningen de gjorde var ”tillräckligt bra”.

Den fritt tillgängliga appen laddades hem av 10 456 gravida och nyförlösta kvinnor under 10 månader vilket motsvarade ca 41% av alla användare under den perioden. Vid inklusion hade 51% av kvinnorna inkontinens. Uppföljningsfrågorna efter tre månader besvarades av 1805 kvinnor. Bland kvinnorna som hade inkontinens vid inklusion upplevde en majoritet att de blivit förbättrade.

Slutsats

Appen Tät® är ett nytt, lättillgängligt och effektivt alternativ för egenbehandling av ansträngningsinkontinens hos kvinnor. Kvinnorna uppskattade att appen möjliggjorde för dem att genomföra sin bäckenbottenträning självständigt. Den fritt tillgängliga appen fick stor spridning och användes av många gravida och nyförlösta kvinnor. Vi tror att appen kan vara användbar för att förebygga urininkontinens hos gravida kvinnor. Vi tror också att appen kan användas både för självständig behandling och i kombination med andra behandlingar inom vården.

Background: Stress urinary incontinence (SUI) affects 10%-39% of women. Its first-line treatment consists of lifestyle interventions and pelvic floor muscle training (PFMT), which can be performed supervised or unsupervised. Health apps are increasing in number and can be used to improve adherence to treatments. We developed the Tät app, which provides a 3-month treatment program with a focus on PFMT for women with SUI. The app treatment was evaluated in a randomized controlled trial, which demonstrated efficacy for improving incontinence symptoms and quality of life. In this qualitative interview study, we investigated participant experiences of the app-based treatment.

Objective: This study aimed to explore women’s experiences of using an app-based treatment program for SUI.

Methods: This qualitative study is based on telephone interviews with 15 selected women, with a mean age of 47 years, who had used the app in the previous randomized controlled trial. A semistructured interview guide with open-ended questions was used, and the interviews were transcribed verbatim. Data were analyzed according to the grounded theory.

Results: The results were grouped into three categories: “Something new!” “Keeping motivation up!” and “Good enough?” A core category, “Enabling my independence,” was identified. The participants appreciated having a new and modern way to access a treatment program for SUI. The use of new technology seemed to make incontinence treatment feel more prioritized and less embarrassing for the subjects. The closeness to their mobile phone and app features like reminders and visual graphs helped support and motivate the women to carry through the PFMT. The participants felt confident that they could perform the treatment program on their own, even though they expressed some uncertainty about whether they were doing the pelvic floor muscle contractions correctly. They felt that the app-based treatment increased their self-confidence and enabled them to take responsibility for their treatment.

Conclusions: Use of the app-based treatment program for SUI empowered the women in this study and helped them self-manage their incontinence treatment. They appreciated the app as a new tool for supporting their motivation to carry through a slightly challenging PFMT program.

Trial Registration: ClinicalTrials.gov NCT01848938; https://clinicaltrials.gov/ct2/show/NCT01848938 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT01848938)

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 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.