Overactive Bladder Syndrome (OAB) is defined by urgency, frequency, and nocturia, with or without urgency urinary incontinence in the absence of pathological causes of these symptoms. This condition affects patients worldwide and can have a great effect on their quality of life. This study aims to investigate the feasibility, acceptability, and preliminary efficacy of a digital intervention, the OAB App, for the conservative management of overactive bladder syndrome. Particularly, this study looks at if the intervention improves the symptoms experienced by patients with overactive bladder syndrome. Furthermore, this study looks at if the participants experience any decrease in the degree of bother on participants due to these symptoms and if there is any improvement in participants’ quality of life. Finally, this study will help to determine the most appropriate outcomes for the OAB app use in a future definitive RCT and the effect size for future sample size calculations.

Participants were selected from clinic waiting lists at each study site. The consultant at each site reviewed patient referral letters from their general practitioner and selected patients that fit the trial inclusion and exclusion criteria (Figure 1). The clinic contacted the patient on behalf of the trial team. An email was sent with a brief description of the study, a recommendation to participate and an online ‘consent to be contacted’ form. If participants were interested in hearing more about the trial or participating, they completed the ‘consent to be contacted’ form. This provided their contact details to the study team who then contacted the participant inviting them to participate in the trial. The email contained a participant information leaflet and an informed consent form as an online link. If participants had any questions about the trial, they either replied to the email or requested a phone call from a member of the study team. 

All participants that agreed to participate and completed the informed consent form downloaded the OAB app. They then completed an 8-week programme; The app guided the participants through 8 evidence-based modules. Each week a new module was made available to the participants. Participants were asked to do bladder retraining with the use of urge suppression techniques and delayed toileting. They also were guided through low-risk physical exercises including pelvic floor exercises, walking, stretching, and body weight strengthening activities. There were also elements of cognitive behaviour therapy they engaged in such as journaling, behaviour retraining, and goal setting. 

Participants completed three study surveys weeks 1, 4, and 8. These surveys contained validated measures to assess the study outcomes and demographic measures to describe the study population. The app collected usage data throughout the 8-week programme. At weeks 1 and 8 participants were prompted by the app to complete a Bladder Diary using the app. 
Outcomes measured included the mean voids in 24 hours, followed through the in-app bladder diary. Patient-reported urgency, frequency of urination, symptom bother and symptom impact on quality of life were also evaluated through the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) (1) and the International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life (ICIQ-OAB-QoL) (2) validated questionnaires. Programme adherence was measured through website analytics based on the percent of the programme completed and programme acceptability was measured through an acceptability questionnaire based on the Patient Global Impression Improvement (PGI-I) (3).

Overall, 100% of our participants reported a reduction in their OAB symptoms and 82% reported an improvement in their quality of life. Paired samples t-tests were conducted as Shapiro-Wilk tests demonstrated that the distribution of the differences in the ICIQ-OAB and ICIQ-OABqol scores was normal. A Bonferroni correction was applied to control for multiple comparisons. The alpha level was adjusted to .017. The intervention significantly reduced patients’ OAB symptoms in 4 weeks and this reduction was maintained to 8 weeks. There was a significant difference in ICIQ-OAB scores between baseline (M=7.13, SD=2.53) and week 4 (M=5.19, SD=2.46; t(15)=3.78, p=.002, d=.78) and between baseline and week 8 (M=5.00, SD=2.52; t(16)=5.28, p<.001, d=.8’). The intervention significantly improved patients’ quality-of-life scores at 4 weeks and this change was maintained to 8 weeks. There was a significant difference in ICIQ-OAB-QoL scores between baseline (M=84.45, SD=20.50) and week 4 (M=69.06, SD=22.14; t(15)=3.12, p=.007, d=.72) and between baseline and week 8 (M=62.41, SD=31.28; t(16)=3.52, p=.003, d=.78). 

Behavioural data were collected from participants in week 1 and week 8 through the in-app digital bladder diary. Participants logged the number of times they went to the toilet daily to create the variable Frequency of Urination. Paired samples t-tests were conducted as a Shapiro-Wilk test demonstrated that the distribution of the differences in Frequency of Urination scores was normally distributed. There was a significant difference in the Frequency of Urination between baseline and week 8 (t(6)=3.28, p=.017, d=.1.07). Participants experienced a significant reduction in the number of times they went to the toilet with the average dropping from 10.19 visits per day at week 1 (SD=3.41) to 6.71 visits at week 8 (SD=1.25). 

Participants also logged the number of incontinence episodes they experienced. Although it was not possible to conduct paired samples t-tests on this data as the Shapiro-Wilk test demonstrated that the distribution of the differences at baseline and week 8 was not normally distributed, participants experienced a reduction in episodes of incontinence with the average dropping from 10 (SD=15.17) at baseline to 3.57 at week 8 (SD=4.58).

The use of the OAB app over an 8 week period lead to significant improvements in participants’ ICIQ-OAB scores. Lower scores are equivalent to improvements in patients’ symptoms of frequency, nocturia, urgency, incontinence, and symptom bother. After the 8 week intervention, lower ICIQ-OABqol were also noted; this indicates improvements in participants’ quality of life concerning their OAB symptoms and experiences. This questionnaire also encompasses an evaluation of participants’ self-confidence and any relationship or mental strain placed on them due to their OAB symptoms. The variable Frequency of Urination, calculated from behavioural data from weeks 1 and 8, also showed a significant decrease between the beginning and end of the intervention. Finally, there was a notable decrease in the average number of incontinence episodes experienced by participants between weeks 1 and 8.

Overactive bladder syndrome has a significant effect on the lives of patients experiencing it. The symptoms of urgency, frequency, and nocturia not only bother patients but also affect their capacity to fulfil daily activities without advanced planning and preparation. This is particularly true in the setting of incontinence. Furthermore, these symptoms may also affect the patients’ views of themselves and their interpersonal relationships. The use of the OAB app has a significant and positive effect on the outcomes measured through the ICIQ-OAB and ICIQ-OABqol validated questionaries. Its use can, therefore, be beneficial in the conservative management of patients with OAB. Furthermore, this intervention can also be implemented to conservatively manage patient symptoms while they are awaiting appointments for clinics.

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Srikrishna S., Robinson D., & Cardozo L., Validation of the Patient Global Impression of Improvement Prolapse. International Urogynecology Journal. 2010; 21(5): 523-528.

Continence 2S2 (2022) 100421
DOI: 10.1016/j.cont.2022.100421