The ageing population in Europe is experiencing a significant rise in urinary incontinence (UI), which affects millions and incurs substantial healthcare costs. While conservative treatment (eg, behavioural strategies, pelvic floor exercises) can help manage UI, there is a need for evidence-based eHealth solutions to improve adherence and treatment outcomes. The KOKU Bladder project aims to co-create, develop and test an eHealth intervention to improve bladder health (BH) and UI in adults aged 50 and over.

Phase 1 will consist of the co-creation and technological development of the eHealth solution. First, a rapid review will be undertaken to identify eHealth solutions (ie, technologies and websites), including behaviour change techniques (BCTs) and elements of gamification for self-management of BH and UI in adults aged 50 and over. Also, a consultation with eight experts on BH/UI and/or BCTs will be conducted to explore recommendations for the new eHealth solution. The PROSECO framework will facilitate an assessment of the co-creation process. Phase 1 will additionally include the conduction of at least six focus groups, to be held in Kaunas (Lithuania), Catalonia (Spain) and Manchester (UK) to co-create the contents of the digital solution. Each focus group will include 10–12 community-dwelling adults aged 50+, with different physical conditions and continence status, as well as health professionals and other stakeholders. The information collected will be analysed thematically. First, we will hold three focus groups, one in each country, to find out the opinion of the participants. Once the focus groups are finished and the first version of the technological solution is created, participants will test it and provide feedback in three additional focus groups. Participants’ opinions will be taken into account to make modifications to the solution and co-create the final version. Gamification methods and the Honeycomb model for user experience will be followed in order to achieve a technological solution that is adequate for its target population.

Phase 2 will consist of a multicentre pilot study with a mixed method (quantitative and qualitative) approach to assess the feasibility and acceptability of the newly developed technological solution. At least 120 participants (40 per country) will be recruited and randomised into two groups: intervention (KOKU Bladder) and control (indirect health education). The primary outcome will be the severity of UI, according to the International Consultation on Incontinence Questionnaire-UI short form. Secondary outcomes will include quality of life (EuroQol 5-Dimension, 5-Level), life-impact related to UI (Incontinence Impact Questionnaire-7), lower urinary tract symptoms (Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-10 (LURN SI-10)), International Consultation Questionnaire on Incontinence Bowel Score, Patient Global Impression of Improvement; levels of physical activity and sedentary behaviour (accelerometer), as well as satisfaction with treatment (Client Satisfaction Questionnaire (CSQ-8)). The latter, together with recruitment, adherence, retention, attrition and data loss, will be used for measuring intervention feasibility and acceptability. Statistical and clinical significance, as well as effect size, will be calculated.

The project is approved by the Research Ethics Committee of IRIS-CC approved the project on 9 January 2025 (code 24/095), the Research Ethics Committee of Hospital Universitari Arnau de Vilanova of Lleida on 27 January 2025 (CEIC-3201), the Commission on Research Ethics of Lithuania on 3 March 2025 (SMTEK-31) and the Research Ethics Committee 3 of the University of Manchester on 13 August 2025 (2025-23619-43258). Participation and withdrawal will be voluntary. Informed consent will be obtained from candidates willing to join the project. Study results will be disseminated via publication of scientific articles, presentations at professional workshops, webinars and congresses, as well as through social media and lay summaries for participants and the general public.

NCT06583733.

CRD42024597624.

Around 885 000 people live with dementia in the UK, of whom around 50% experience a fall each year. ‘Keep On Keep Up’ (KOKU) is a National Health Service-approved gamified, digital health programme designed to maintain function and reduce falls through strength and balance exercises (Fitness and Mobility Exercise/OTAGO Exercise Programme (OTAGO)), and health literacy games. KOKU has been adapted to the needs of people living with dementia in the community (known as KOKU-LITE). This trial aims to test the feasibility and acceptability of trial processes and usability of KOKU-LITE.

A two-arm, parallel, non-blinded feasibility randomised controlled trial will be conducted using mixed methods. Participants aged ≥55 years with any type but varying levels of dementia from mild to moderate stages (ratings 1 and 2 on clinical dementia rating (CDR) scale) and meeting the eligibility criteria will be recruited from patient organisations across Greater Manchester, UK. The target sample size is 60 for the trial. Participants randomised into the intervention arm will use the KOKU-LITE programme for 30 min, 3 times a week for 6 weeks plus dementia-specific falls prevention leaflet and participants randomised into the control arm will receive dementia-specific falls prevention leaflet. Outcome measures: primary outcomes: recruitment, retention and adherence rates; secondary outcomes: quality of life, participants’ activities of daily living, physical activity levels, functional ability, lower limb strength, concerns about falling, falls risk, mood and user’s experience of the technology. Post-intervention interviews or focus groups with participants and health and social care professionals will explore the feasibility of trial processes and technology and evaluate the usability and acceptability of the intervention, respectively. Analyses will be descriptive.

Trial status: the first participants were recruited on 20 March 2024. Data collection is currently ongoing.

This feasibility trial has been reviewed and received favourable ethical approval from Yorkshire & The Humber—Bradford Leeds Research Ethics Committee, Newcastle upon Tyne (REC reference 23/YH/0262). The findings of the study will be disseminated through peer-reviewed scientific journals, at conferences, publication on University of Manchester, Applied Research Collaboration Greater Manchester and KOKU websites.

NCT06149702.