Developing a digital health program for bladder health in older adults
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This study is testing a new digital health program to improve bladder health for adults aged 50 and older by getting feedback from users and health experts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 50 Years to 100 Years |
| Sex | All |
| Sponsor | University of Vic - Central University of Catalonia Academic / other |
| Locations | 4 sites (Kaunas and 3 other locations) |
| Trial ID | NCT06583733 on ClinicalTrials.gov |
What this trial studies
The KOKU Bladder initiative aims to create and evaluate a digital health program designed to enhance bladder health among adults aged 50 and older. Utilizing a participatory approach, the program will be co-developed with input from end-users, health professionals, and researchers across multiple countries, including Lithuania, Spain, and the UK. The project will involve focus groups to gather insights and preferences, followed by the implementation of a randomized controlled trial to assess the program's feasibility and acceptability. A mixed methods approach will be employed to analyze both quantitative and qualitative data.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 50 and over who experience urinary incontinence and have access to a mobile device.
Not a fit: Patients with unstable health conditions or red-flag symptoms such as bleeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve bladder health management and quality of life for older adults experiencing urinary incontinence.
How similar studies have performed: Other studies have shown promise in using digital health solutions for managing urinary incontinence, indicating that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥50 (range used in the literature covering the late-life process, including prostate issues and the perimenopause period) * Self-reported UI (at least 1 leakage/month) * Ability to read and understand the national languages * Have a mobile phone/tablet * Sign informed consent. Exclusion Criteria: * Red-flag symptoms (e.g., bleeding) * Unstable health conditions.
Where this trial is running
Kaunas and 3 other locations
- Lithuanian Sports University — Kaunas, Lithuania (Recruiting)
- Hospital Santa Maria — Lleida, Spain (Recruiting)
- Hospital Consortium of Vic — Vic, Spain (Recruiting)
- University of Manchester — Manchester, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Jerez-Roig, PhD — University of Vic-Central University of Catalonia; Lithuanian Sports University
- Study coordinator: Javier Jerez-Roig, Professor, PhD
- Email: javier.jerez@uvic.cat
- Phone: +34 93 881 60 25
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.