To evaluate the feasibility of future research to validate the hypothesis that the developed app (Fig.1) can improve PFMT adherence and symptoms of UI, as well as to examine its usability.

Female patients who visited two medical clinics with the complaint of UI were enrolled. The study design’s feasibility and app’s usability were evaluated after eight weeks. Feasibility outcomes included recruitment rate, retention rate, understanding of the questionnaire, PFMT adherence, and safety. Usability was assessed by the System Usability Scale (SUS), a tool for evaluating software or applications. UI severity was measured by the 24-hr pad test before and after the intervention. Participants also completed the International Consultation on Incontinence - Short Form (ICIQ-SF) and King’s Health Questionnaire (KHQ) via the app; answers were collected automatically in email format. The daily PFMT regimen consisted of 10 contractions, each held for 5 seconds followed by 10 seconds of rest, three times per day. The contraction positions may be different.   The app sent push notifications to participants’ smartphones at set times, and signaled the timing of when to contract and relax the pelvic floor muscles via vibrations and sounds.

Nine women were enrolled during the three-month recruitment period (age: 52.3±9.5 y, BMI: 3.7±5.7 kg/m2 [mean±SD]; duration of incontinence symptoms: 15(8-28) y [median (IQR)]). Five of them completed the entire eight-week intervention. One of the four who dropped out was unable to download the app, while the other did so successfully but was unable to operate it; two subjects were lost for unknown reasons. The seven participants who could download and utilize the app had the following subtypes of UI at baseline: stress incontinence (n=2, 28.6%), mixed incontinence (n=5, 71.4%). PFMT adherence for the five subjects who completed the entire intervention were: total contractions: 680(124-1365) times; 22(4-56) days. Mean SUS score was 72.6 at the end of the intervention. No adverse events were reported throughout the study period.

We encountered difficulty enrolling a sufficiently high number of cases, as few women visited clinics with the complaint of UI. Given their relatively high age, many of them may not have been used to operating a smartphone. We experienced no technical issues in collecting participants’ responses via the app; however, the eight-week dropout rate was high, reflecting poor PFMT adherence. However, the app seems to be safe, since no adverse events were reported, and suggests it is very usable, since the SUS score at eight weeks was higher than the reference.

We therefore conclude this pilot study’s design would not be very feasible for future research, necessitating a review of the methodology.