NCT Number: NCT05170100
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
The National Maternity Hospital, Dublin, Ireland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: baseline and week 8
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
Time frame: baseline and week 8
Change from baseline patient-reported overactive bladder symptoms at week 8. Minimum score 0, maximum score 16. Greater values indicate increased symptom severity.
Time frame: baseline & week 8
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.
Time frame: data collected throughout the 8 week intervention.
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.
Time frame: week 4
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.
Time frame: week 8
One item questionnaire with Likert scale of 1 to 7. Greater values indicate disimproved condion.
Time frame: baseline and week 4
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.
Time frame: baseline and week 4
Change from baseline patient-reported overactive bladder symptoms at week 4. Minimum score 0, maximum score 16. Greater values indicate increased symptom severity.
National University of Ireland, Galway, Ireland
Other
Evaluating a Digital Intervention for Overactive Bladder: Protocol for a Single-arm, Multisite Pilot Clinical Trial
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