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| Name | Class |
|---|---|
| Enterprise Ireland | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NUIG OAB App | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NUIG OAB App | Behavioral | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brendan Staunton | National University of Ireland, Galway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Rotunda Hospital | Dublin | D01 P5W9 | Ireland | |||
| The National Maternity Hospital |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| 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 |
| Dublin |
| D02 YH21 |
| Ireland |
| Galway University Hospital | Galway | H91 YR71 | Ireland |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |