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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

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.