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Evaluating a Digital Intervention for Overactive Bladder

NCT ID: NCT05170100

Last Updated: 2021-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2021-11-07

Brief Summary

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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.

Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

NUIG OAB App

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Enterprise Ireland

OTHER_GOV

Sponsor Role collaborator

National University of Ireland, Galway, Ireland

OTHER

Sponsor Role lead

Responsible Party

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Emma Carr

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brendan Staunton

Role: PRINCIPAL_INVESTIGATOR

National University of Ireland, Galway

Locations

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The Rotunda Hospital

Dublin, , Ireland

Site Status

The National Maternity Hospital

Dublin, , Ireland

Site Status

Galway University Hospital

Galway, , Ireland

Site Status

Countries

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Ireland

Other Identifiers

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CF20201467I

Identifier Type: -

Identifier Source: org_study_id