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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.

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.

Introduction: Pregnancy and childbirth are risk factors for developing urinary incontinence (UI). The prevalence of UI has been reported at 58% in late pregnancy and at around 30% in the three months after childbirth. Pelvic floor muscle training (PFMT) during pregnancy can prevent the onset of UI. We developed the mobile app Tät with a PFMT program for women with stress urinary incontinence. We evaluated its efficacy in a randomized controlled trial and found that the app group experienced fewer incontinence symptoms, fewer leakages, and better quality of life compared to the control group. The app is now freely available, and the aim of this study was to investigate the use of the app by pregnant and postnatal women.

Methods: We included pregnant and postnatal (childbirth in the last three months) women who had downloaded the app between January 16 and November 15 2018 and answered the inclusion questionnaire within the app. Questions included age, gender, country, place of residence, education, reason for download, pregnancy, childbirth in the last three months, and incontinence symptoms according to the ICIQ-UI SF. After three months a follow-up questionnaire appeared in the app. All answers were sent anonymously to our research database.

Results: 10 456 women were included (4 607 pregnant, 5 849 postnatal). The mean age was 31 years and 95% lived in Sweden. 47% of the pregnant women and 55% of the postnatal women reported having UI. The mean ICIQ-UI SF score of those with UI was 6.7 (SD 3.4). 1 805 women answered the follow-up and almost three quarters had used the app and performed PFMT at least weekly. Of those with incontinence, the majority experienced improvement with mean ICIQ-UI SF scores improving significantly at follow-up, except in the subgroup “pregnant both at inclusion and follow-up”.

Conclusion: The Tät app is widely used by pregnant and postnatal women in Sweden for prevention and treatment of UI. Postnatal women with incontinence experienced the largest improvements and reductions in ICIQ-UI SF score. With this study design we cannot say if this effect relates to the use of the app or is the natural improvement of UI over time.

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)

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: 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.