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.