Evaluating a Digital Intervention for Overactive Bladder

Not Applicable

Completed

• Conditions: Overactive Bladder
• Interventions: Behavioral: NUIG OAB App

• Registration Number: NCT05170100
• Lead Sponsor: National University of Ireland, Galway, Ireland

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-10-29
• Primary Completion: 2021-11-07
• Study Completion: 2021-11-07
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-10
• Last Update Submitted: 2021-12-10
• Study First Posted: 2021-12-27
• Last Update Posted: 2021-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

Inclusion Criteria

1. On waiting list for Urogynaecologist at participating hospital
2. Referred for Overactive bladder from GP
3. Symptoms of Overactive bladder to include at least one of the following: urgency of urination, frequency of urination or urge incontinence.
4. Female
5. 18 years or older
6. Own a smartphone

Exclusion Criteria

1. Active/Recurrent urinary tract infection
2. Urinary retention
3. Bladder Pain Syndrome/ interstitial cystitis
4. Pelvic/gynae cancer
5. Pregnant
6. Dementia
7. Kidney problems
8. Stroke
9. Have/had a neuro-stimulation implant for treatment of OAB

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NUIG OAB App	NUIG OAB App	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.

Primary Outcome Measures

Name	Time	Method
Change in International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module (ICIQ-OABqol)	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
Change in International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB)	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.
Change in Digital Bladder Diary frequency of urination	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.

Secondary Outcome Measures

Name	Time	Method
Programme adherence	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.
Patient Global impression of improvement	week 8	One item questionnaire with Likert scale of 1 to 7. Greater values indicate disimproved condion.
Change in International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module (ICIQ-OABqol)	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.
Change in International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB)	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.
Mobile Applications Rating Scale, user version (MARSu)	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.

Trial Locations

Locations (3)

Galway University Hospital; 🇮🇪 Galway, Ireland

The Rotunda Hospital; 🇮🇪 Dublin, Ireland

The National Maternity Hospital; 🇮🇪 Dublin, Ireland