Clinical trial NCT05170100: Evaluating a Digital Intervention for Overactive Bladder
Official title: Evaluating a Digital Intervention for Overactive Bladder: Protocol for a Single-arm, Multisite Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
Collaborators: name: Enterprise Ireland
First posted: 2021-12-27
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module (ICIQ-OABqol)
timeFrame: baseline and week 8
measure: Change in International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB)
timeFrame: baseline and week 8
measure: Change in Digital Bladder Diary frequency of urination
timeFrame: baseline & week 8
Secondary outcomes:
measure: Programme adherence
timeFrame: data collected throughout the 8 week intervention.
measure: Mobile Applications Rating Scale, user version (MARSu)
timeFrame: week 4
measure: Patient Global impression of improvement
timeFrame: week 8
measure: Change in International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Module (ICIQ-OABqol)
timeFrame: baseline and week 4
measure: Change in International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB)
timeFrame: baseline and week 4
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: The Rotunda Hospital
city: Dublin
country: Ireland
facility: The National Maternity Hospital
city: Galway
country: Ireland
facility: Galway University Hospital
Study officials:
affiliation: National University of Ireland, Galway
name: Brendan Staunton
role: PRINCIPAL_INVESTIGATOR
References: