Evaluating a Digital Intervention for Overactive Bladder

NCT05170100 | Completed

• 1 other identifier: CF20201467I
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Programme adherence

  data collected throughout the 8 week intervention.

• Mobile Applications Rating Scale, user version (MARSu)

  week 4

• Patient Global impression of improvement

  week 8

• Change in International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module (ICIQ-OABqol)

  baseline and week 4

• Change in International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB)

  baseline and week 4

Study Arms (1)

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.

Behavioral: NUIG OAB App

Interventions

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.

NUIG OAB App

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Active/Recurrent urinary tract infection
• Urinary retention
• Bladder Pain Syndrome/ interstitial cystitis
• Pelvic/gynae cancer
• Pregnant
• Dementia
• Kidney problems
• Stroke
• Have/had a neuro-stimulation implant for treatment of OAB

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead
• Enterprise Ireland: collaborator

Study Sites (3)

The Rotunda Hospital

Dublin, D01 P5W9, Ireland

Location

The National Maternity Hospital

Dublin, D02 YH21, Ireland

Location

Galway University Hospital

Galway, H91 YR71, Ireland

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brendan Staunton

  National University of Ireland, Galway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: December 27, 2021
• Study Start: September 1, 2021
• Primary Completion: November 7, 2021
• Study Completion: November 7, 2021
• Last Updated: December 27, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

IE (3)