Evaluating a Digital Intervention for Overactive Bladder

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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Behavioral: NUIG OAB App

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, D01 P5W9
    • The Rotunda Hospital
  • Dublin, Ireland, D02 YH21
    • The National Maternity Hospital
  • Galway, Ireland, H91 YR71
    • Galway University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National University of Ireland, Galway, Ireland
• Collaborators: Enterprise Ireland
• Investigators: Principal Investigator: Brendan Staunton, National University of Ireland, Galway

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2021
• Primary Completion (ACTUAL): November 7, 2021
• Study Completion (ACTUAL): November 7, 2021

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (ACTUAL): December 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 27, 2021
• Last Update Submitted That Met QC Criteria: December 10, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: CF20201467I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No