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Background: Urinary incontinence is a common condition among women[1], affecting approximately one in every three women in Sweden. The three most common types of urinary incontinence are stress urinary incontinence (SUI, leakage upon physical exertion); urgency urinary incontinence (UUI, leakage with a sense of urgency); and mixed urinary incontinence (MUI, a combination of SUI and UUI). Previous studies have shown that app-based interventions are effective treatments for SUI.  

Aim of the thesis: The focus of this thesis was a new app-based intervention, the Tät® II app, which was designed for the self-management of UUI and MUI. The aim was to evaluate the short-term and long-term effects of its use, and to study aspects related to treatment satisfaction.  

Methods: This thesis is based on data from two studies: a randomized controlled trial, followed by a cohort study to assess long-term effects. The results of these two studies are presented in three separate papers. The study participants were women ≥18 years old with UUI or MUI, diagnosed via telephone interview, who experienced ≥2 leakages per week, and who enrolled in a randomized controlled trial (ClinicalTrials.gov, NCT03097549). The intervention was the Tät® II treatment app, which included information and treatment programs on pelvic floor muscle training (PFMT) and bladder training; psychoeducation; lifestyle advice; automated feedback; tailored advice; training statistics; and optional reminder notifications. The control was a limited version of the Tät® II app, featuring only brief information on the different topics.  

The participants were randomized into receiving access to either the treatment app or the control app. Short-term efficacy was evaluated at 15 weeks based on the difference in urinary incontinence symptoms between the treatment group and control group, using the validated International Consultation on Incontinence Questionnaire − Urinary Incontinence Short Form (ICIQ-UI SF) (Paper I). After this, the control group also received the intervention. 

A long-term follow-up was performed 15 months after the participants had received the treatment app; the participants were considered to be one cohort, regardless of their previous allocation. The long-term effects were evaluated using the change in urinary incontinence symptoms (ICIQ-UI SF score) between baseline and the 15-month follow-up (Paper II). 

In addition, a selection of factors measured at baseline and the short-term follow-up were analyzed for correlation with treatment satisfaction at the long-term follow-up (Paper III). All participants who answered “yes” to the question “Do you currently consider that the treatment you have undergone is satisfactory?” were defined as satisfied. 

Results: A total of 123 women were included and randomized to the treatment app (n=60) or the control app (n=63). The mean age of the participants was 58 (SD 9) years. Approximately one quarter had UUI, and three quarters had MUI. The incontinence was classified as severe or very severe in 38% of the participants and moderate in 59%, based on the Incontinence Severity Index. Two participants were lost to the short-term follow-up, and an additional 17 participants were lost to the long-term follow-up. 

At the short-term follow-up, the mean ICIQ-UI SF score (incontinence symptoms) improved from 11.7 to 7.0 in the treatment group, and from 11.4 to 9.8 in the control group. The estimated between-group difference for ICIQ-UI SF score at the short-term follow-up was −3.1 (95% CI, −4.8 to −1.3, p<0.001), in favor of the treatment group. 

The cohort analysis at the long-term follow-up yielded improvements of a similar magnitude: the ICIQ‐UI SF mean score changed from 11.5 at baseline to 7.6 at the long-term follow-up (mean difference 4.0, 95% CI 3.2–4.7, p<0.001).  

In total, 58% of the women were satisfied with the treatment at the long-term follow-up. The most important variables associated with satisfaction were higher incontinence-related quality of life (ICIQ−Lower Urinary Tract Symptoms Quality of Life module, ICIQ-LUTSqol) (OR 0.91, 95% CI 0.58–0.97) at baseline; as well as 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) at the 15-week follow-up.  

Conclusion: The research presented in this thesis showed that the Tät® II treatment app is effective in improving UUI and MUI in women, and that the effect was clinically significant in the long term. Furthermore, the majority of the study participants were satisfied with the treatment long-term—in particular those who had a higher quality-of-life pre-treatment, and who exhibited confidence in their ability in PFMT and better bladder control post-treatment.  

App-based self-management represents a good alternative or complement to pharmacological and other conservative treatments for these conditions. It may be offered as a first-line treatment, especially for patients who are suited for and capable of utilizing this method effectively. 

 [1] In this thesis, ‘woman’ refers to someone who was assigned female gender at birth. A brief discussion of the reason for this definition is given in the ‘Methods’ section.

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.

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.

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.