JMIR Publications

ABSTRACT

Background:

Many women experience urgency and mixed urinary incontinence, but commonly hesitate to seek care. Treatment access and self-management can be supported through eHealth methods.

Objective:

This study investigated the efficacy of a mobile app for self-management of urgency and mixed urinary incontinence.

Methods:

This randomised controlled trial was conducted in Sweden. We included women of ≥18 year old, with urgency or mixed urinary incontinence and ≥2 leakages/week, excluding those with alarm symptoms. The women were recruited via information on TV, radio, and newspapers, and via Facebook advertisements. Initial selection was performed using a web-based screening questionnaire at our webpage. Data was then collected using an inclusion questionnaire and a two-day bladder diary. Symptom diagnosis was confirmed through a telephone interview. Participants were randomised to a treatment app (pelvic floor muscle training, bladder training, psychology, lifestyle advice, individual advice, statistics, reinforcement messages, and reminders) or brief information app (control). No guidance on the treatment was provided outside of the apps. The primary outcome was incontinence symptoms at follow-up (15 weeks), measured by ICIQ-UI SF score. Urgency symptoms were assessed via ICIQ-OAB score, and quality of life via ICIQ-LUTSqol score. Improvement was measured using Patient’s Global Impression of Improvement (PGI-I). These outcomes were patient reported. Cure was defined as no leakages (based on bladder diary). Intention-to-treat analysis was performed.

Results:

Between April 2017 and March 2018, 123 women were randomised to treatment (n=60, two lost to follow-up) or information (n=63). Of the included women, 28% had symptoms of urgency urinary incontinence, and 72% had mixed urinary incontinence. The mean age was 58.3 (SD 9.6) years and the majority had a university education. Half of the women were overweight or obese. Baseline characteristics did not differ between the two groups. The mean follow-up ICIQ-UI SF score was lower in the treatment group than the information group (estimated difference 3.1; 95% CI −4.8 to −1.3). For the follow-up ICIQ-OAB score, the estimated between-groups difference was −1∙8 (95% CI −2∙8 to −0∙99) and for the ICIQ-LUTSqol, the estimated between-groups difference was -6.3 (95% CI -10.5 to -2.1). Of women in the treatment group 90% reported an improvement, compared to 30% in the information group. Cure was reported by 19 women in the treatment group, and 4 in the control group (OR 5.38, 95% CI 1.86 to 15.57, p=0.002). During the 15-week treatment period, 69% of women in the treatment group used the app daily, and 10% used it at least three times per day.

Conclusions:

The tested treatment app was effective for improvement and cure of urgency and mixed incontinence in women. It may be a good alternative to pharmacological treatment or other conservative management, increasing access to care. Clinical Trial: ClinicalTrials.gov NCT03097549