Evaluating a Digital Intervention for Overactive Bladder

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05170100
• Other study ID #: CF20201467I
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: November 7, 2021

Study information

• Verified date: December 2021
• Source: National University of Ireland, Galway, Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 7, 2021
• Est. primary completion date: November 7, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Behavioral:
• NUIG OAB App
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.

Locations

Country	Name	City	State
Ireland	The National Maternity Hospital	Dublin
Ireland	The Rotunda Hospital	Dublin
Ireland	Galway University Hospital	Galway

Sponsors (2)

Lead Sponsor	Collaborator
National University of Ireland, Galway, Ireland	Enterprise Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.
Secondary	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
Secondary	Patient Global impression of improvement	One item questionnaire with Likert scale of 1 to 7. Greater values indicate disimproved condion.	week 8
Secondary	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
Secondary	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