Overactive BladderNCT05170100
Evaluating a Digital Intervention for Overactive Bladder
A study testing NUIG OAB App in people with Overactive Bladder, run by National University of Ireland, Galway, Ireland at 3 sites in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- NUIG OAB App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesIreland
- Study dates
- 1 Sep 2021to 7 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 18 years or older
- Own a smartphone
Who cannot join
- Active/Recurrent urinary tract infection
- Urinary retention
- Bladder Pain Syndrome/ interstitial cystitis
- Pelvic/gynae cancer
- Pregnant
- Dementia
Show all 9Show fewer
- Kidney problems
- Stroke
- Have/had a neuro-stimulation implant for treatment of OAB
Trial locations and contacts
3 sites in 1 country.
Ireland3 sites
The Rotunda Hospital
Dublin, D01 P5W9
The National Maternity Hospital
Dublin, D02 YH21
Galway University Hospital
Galway, H91 YR71
About this study
Official title: 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.
- Conditions
- Overactive Bladder
- Being tested
- NUIG OAB App
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NUIG OAB AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: NUIG OAB App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: baseline & week 8
Secondary outcomes (5)
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.
Measured: 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.
Measured: week 4
Patient Global impression of improvement
One item questionnaire with Likert scale of 1 to 7. Greater values indicate disimproved condion.
Measured: 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.
Measured: 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.
Measured: baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start1 Sep 2021
- Primary completion7 Nov 2021
- Study completion7 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Enterprise Ireland
- Responsible party
- Principal investigator, Emma Carr, National University of Ireland, Galway, Ireland
- Investigators
- Brendan Staunton, Principal investigator, National University of Ireland, Galway, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170100
- Sponsor's protocol ID
- CF20201467I
- Status last verified
- Dec 2021
- First submitted
- 29 Oct 2021
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Digital Intervention for Overactive Bladder: Protocol for a Single-arm, Multisite Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT05170100
- Acronym / sponsor ID
- CF20201467I
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Collaborators
- Enterprise Ireland
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 7 Nov 2021 (actual)
- Study completion
- 7 Nov 2021 (actual)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NUIG OAB App | Experimental | Behavioral: NUIG OAB AppDigital 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- 18 years or older
Key exclusion criteria (9 listed)
- Active/Recurrent urinary tract infection
- Urinary retention
- Bladder Pain Syndrome/ interstitial cystitis
- Pelvic/gynae cancer
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NUIG OAB AppAn 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. | Behavioural | NUIG OAB App |
Primary outcome
Change in International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module (ICIQ-OABqol)
Time frame: 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)
Time frame: 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
Time frame: 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.
5 secondary outcomes
Programme adherence
Time frame: data collected throughout the 8 week intervention.
Mobile Applications Rating Scale, user version (MARSu)
Time frame: week 4
Patient Global impression of improvement
Time frame: week 8
Change in International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module (ICIQ-OABqol)
Time frame: baseline and week 4
Change in International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB)
Time frame: baseline and week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brendan Staunton principal investigator
National University of Ireland, Galway, Ireland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NUIG OAB App in people with Overactive Bladder, run by National University of Ireland, Galway, Ireland at 3 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module (ICIQ-OABqol) (time frame: baseline and week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2021; AzTrials last refreshed its copy on 27 Oct 2026.