Long-term results of app-based self-management of urgency and mixed urinary incontinence in women

Wadensten T1, Nyström E2, Nord A1, Lindam A3, Sjöström M1, Samuelsson E1

Research Type

Clinical

Abstract Category

E-Health

Abstract 234
Best Conservative Management 1
Scientific Podium Session 16
Friday 9th September 2022
10:05 - 10:20
Hall K1/2
Urgency Urinary Incontinence Mixed Urinary Incontinence Conservative Treatment Female New Devices
1. Family Medicine, Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden, 2. Unit of Research, Education, and Development, Östersund Hospital, Östersund, Sweden; Family Medicine, Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden, 3. Unit of Research, Education, and Development, Östersund Hospital, Östersund, Sweden
Online
Presenter
Links

Abstract

Hypothesis / aims of study
Urgency (UUI) and mixed (MUI) urinary incontinence are common conditions affecting up to a quarter of all women, often with a significant impact on quality of life. UUI is defined as urinary leakage upon a sense of urgency, and MUI is defined as a combination of urgency and stress-related urinary leakages. 
The behavioral interventions recommended as first-line treatments for UUI and MUI include pelvic floor muscle training (PFMT) and lifestyle changes. In addition, bladder training, or scheduled voiding, is recommended in some cases. Pharmacological therapy is widely prescribed, but treatment satisfaction is lower than with behavioral interventions, and discontinuation is common – partly due to unwanted side-effects. 
In the last years, telehealth interventions such as mobile apps have been shown to have potential as aids for long-term self-management in various chronical conditions, and an additional boost for telehealth has been predicted subsequent to the Covid-19 pandemic. Recent reviews have examined the effect and implementation of apps and other telehealth interventions in several urological conditions, including urinary incontinence, and found that they are an effective treatment alternative that can be implemented successfully. However, studies of the long-term result of behavioral interventions in general, and telehealth interventions in particular, targeting urinary incontinence are scarce.
A recent RCT showed that a new app was effective for self-management of UUI and MUI in women. After 15 weeks of treatment, women who received the app had a clinically relevant improvement in all outcomes, including incontinence symptoms and quality of life (1). However, there is a knowledge gap regarding the long-term effect of treatment specifically for UUI and MUI, both regarding app-based interventions and other interventions. Therefore, the aim of this study was to evaluate the long-term effect of the app for treatment of UUI and MUI in women.
Study design, materials and methods
This was a long-term follow-up of a randomized controlled trial (RCT), including 123 women ≥18 years old with UUI or MUI, without red-flag symptoms, and ≥2 leakages per week. The original RCT was well powered and registered on ClinicalTrials.org and monitored on-site by an independent monitor (1). 
All participants, regardless of their original allocation to intervention or control, had received the intervention, a treatment app, at the long-term follow-up. Long-term data was collected through web-based questionnaires 15 months after participants received the intervention. 
The app was developed based on scientific evidence and clinical experience. It included pelvic floor muscle training, bladder training, psychoeducation, lifestyle advice, an exercise log, reminders, reinforcement messages, and tailored advice. The primary outcome was 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)). The Incontinence Catastrophizing (IC) Scale (0-21 points) was used to assess the participant’s tendency to catastrophize over their incontinence. It was adapted from the validated Pain Catastrophizing Scale (short version) and contains 7 items covering fear of leakage and urgency.
A paired t-test was used to estimate the change in mean score for continuous variables. Comparisons were made between baseline and long-term follow-up, and between short-term and long-term follow-up. 
The software IBM SPSS version 25 was used for all analyses.
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), the ICIQ-LUTSqol improved from 38.0 to 30.9 (mean difference 7.1, 95% CI 5.7-8.5) and the IC score improved from 4.8 to 2.5 (mean difference 2.2, 95% CI 1.6 to 2.8). The difference between baseline and the long-term follow-up score was statistically significant for all outcomes (Table 1). There were no significant differences in any of the scores between the short-term and long-term follow-up (Figure 1).
According to the PGI-I, improvement in incontinence symptoms from baseline to the long-term follow-up was reported by 73% (74/102) of the women.
Interpretation of results
This is the first study of the long-term results of using a complex app for self-management of UUI and MUI specifically. The results show that treatment with the app resulted in significant and clinically relevant long-term improvement of UUI and MUI regarding all parameters measured: incontinence symptoms (ICIQ-UI SF), urgency (ICIQ-OAB), quality of life (ICIQ-LUTSqol), and catastrophizing (IC-Scale). Furthermore, the improvement at the short-term follow-up was sustained at the long-term follow-up for all outcomes. The full results of this study were reported in a paper published in March 2022 (2).
Our study participants had a mean ICIQ-UI SF score improvement of -4.0 points at the long-term follow-up. This improvement is of similar, or slightly larger, magnitude compared with other long-term studies. A recent long-term study found a mean improvement in the ICIQ-UI SF score of -2.17 for app-based treatment of UUI, MUI or stress urinary incontinence, compared with -3.43 for care-as-usual (3). 
One limitation of this long-term follow-up study is the lack of a control group. The original control group from the RCT received the intervention after the initial follow-up and was analyzed together with the original intervention group.
Concluding message
This study showed that self-management with the app was effective for long-term reduction of urinary leakage and urgency symptoms, and improved incontinence-related quality of life, for women with UUI and MUI. An app providing an extensive intervention for these conditions might be a valuable addition to other first-line treatments, both over the short and long term.
Figure 1 Table 1. Continuous outcomes at baseline and at the long-term follow-up. aAnalyzed using a paired t test.
Figure 2 Figure 1. Overview of the change over time for the symptom mean scores. The error bars represent 95% CI. aPlease note that the lowest possible score for the ICIQ-LUTSqol is 19.
References
  1. Wadensten T, Nystrom E, Franzen K, Lindam A, Wasteson E, Samuelsson E. A Mobile App for Self-management of Urgency and Mixed Urinary Incontinence in Women: Randomized Controlled Trial. J Med Internet Res. 2021;23(4):e19439.
  2. Wadensten T, Nyström E, Nord A, Lindam A, Sjöström M, Samuelsson E. App-based self-management of urgency and mixed urinary incontinence in women: One-year follow-up. Neurourol Urodyn. 2022 Mar 9. doi: 10.1002/nau.24898. Epub ahead of print. PMID: 35266189.
  3. Loohuis AMM, Van Der Worp H, Wessels NJ, Dekker JH, Slieker-Ten Hove MCP, Berger MY, et al. One year effectiveness of an app-based treatment for urinary incontinence in comparison to care as usual in Dutch general practice: A pragmatic randomised controlled trial over 12 months. BJOG. 2021.
Disclosures
Funding Our study was funded by the Kamprad Family Foundation; the Region Jämtland Härjedalen; and Visare Norr, Northern County Councils, Sweden. These organizations provided grants but had no role in the study design, data collection, data analysis, data interpretation, or writing of the manuscript. Clinical Trial Yes Registration Number Clinicaltrials.gov NCT03097549 RCT No Subjects Human Ethics Committee The regional ethical review board of Umeå, Sweden Helsinki Yes Informed Consent Yes
Citation

Continence 2S2 (2022) 100323
DOI: 10.1016/j.cont.2022.100323

20/11/2024 22:40:02