Evaluating a Digital Intervention for Overactive Bladder

Study Overview
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Brief Summary
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Overactive Bladder is characterised by (I) Urgency: the sudden and compelling desire to pass urine with or without accidental leakage; (II) Frequency: the need to pass urine far more regularly than is considered normal; and (III) Nocturia: the need to pass urine several times during the night. This study aims to investigate the feasibility, acceptability and preliminary efficacy of a digital intervention (the NUIG OAB App) for overactive bladder. Furthermore, this study will help determine the most appropriate outcomes for use in the future definitive RCT and the effect size for future sample size calculations. Participants will complete an 8-week intervention designed to reduce the symptoms of OAB, delivered through the NUIG OAB App. Participants will be asked to complete online surveys at baseline, 4 weeks and 8 weeks and an in-app Bladder Diary at weeks 1 and 8. There will be no in-person contact with participants by the study team.

Official Title
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Evaluating a Digital Intervention for Overactive Bladder: Protocol for a Single-arm, Multisite Pilot Clinical Trial

Conditions
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Overactive Bladder

Intervention / Treatment
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* Behavioral: NUIG OAB App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: On waiting list for Urogynaecologist at participating hospital Referred for Overactive bladder from GP Symptoms of Overactive bladder to include at least one of the following: urgency of urination, frequency of urination or urge incontinence. Female 18 years or older Own a smartphone Exclusion Criteria: Active/Recurrent urinary tract infection Urinary retention Bladder Pain Syndrome/ interstitial cystitis Pelvic/gynae cancer Pregnant Dementia Kidney problems Stroke Have/had a neuro-stimulation implant for treatment of OAB

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NUIG OAB App<br>Digital behaviour change intervention. Software-delivered intervention including best-practice behavioural therapy, and evidence-based dietetics, physiotherapy and psychology treatments to reduce the symptoms of overactive bladder. | Behavioral: NUIG OAB App<br>* An interactive software-delivered 8-week intervention accessed through the patients' mobile device. It provides best-practice behavioural therapy, and delivers evidence-based dietetics, physiotherapy and psychology treatments to reduce the symptoms of overactive bladder.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module (ICIQ-OABqol) | Change from baseline patient-reported overactive bladder related quality of life at week 8. Minimum score 25, maximum score 160. Greater values indicating increased impact on quality of life | baseline and week 8 | 
| Change in International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB) | Change from baseline patient-reported overactive bladder symptoms at week 8. Minimum score 0, maximum score 16. Greater values indicate increased symptom severity. | baseline and week 8 | 
| Change in Digital Bladder Diary frequency of urination | Change from baseline frequency of urination at week 8. Frequency of urination measured in-app, in real-time as number of urinations per day logged by user for 3 days at baseline and 3 days in week 8. | baseline & week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Programme adherence | Total number of seconds spent on app from day 1 of week 1 to day 7 of week 8. Total number of times app accessed between day 1 of week 1 and day 7 of week 8. Total number of in-app 'challenges' completed throughout the 8 week intervention. | data collected throughout the 8 week intervention. | 
| Mobile Applications Rating Scale, user version (MARSu) | User reported ratings of app quality based on Engagement, Functionality, Aesthetics, and Information. Minimum score 20, maximum score 100. Greater values indicate higher app quality. | week 4 | 
| Patient Global impression of improvement | One item questionnaire with Likert scale of 1 to 7. Greater values indicate disimproved condion. | week 8 | 
| Change in International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module (ICIQ-OABqol) | Change from baseline patient-reported overactive bladder related quality of life at week 4. Minimum score 25, maximum score 160. Greater values indicate increased impact on quality of life. | baseline and week 4 | 
| Change in International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB) | Change from baseline patient-reported overactive bladder symptoms at week 4. Minimum score 0, maximum score 16. Greater values indicate increased symptom severity. | baseline and week 4 |