Keep On Keep Up Bladder Health: Co-creating and Testing a Self-management Technological Solution for Ageing Well

NCT06583733 | Recruiting

• 1 other identifier: KOKU Bladder
• Study Type: interventional
• Target: 120
• Locations: 3 countries
• Sites: 4

Brief Summary

KOKU Bladder aims to develop and test an evidence based digital health program with behavior change techniques to improve bladder health of adults aged 50 and over. A novel module embedded in the approved app "Keep-on-Keep-up" (KOKU) will be co-created with end-users, researchers, health professionals, and stakeholders through a participatory and appreciative action and reflection methodology. After a comprehensive literature review and consultation with 4-6 experts, 6 focus groups will be undertaken in Kaunas(Lithuanian), Catalonia (Spain) and Manchester (UK) to co-create the contents of the module. Data will be analyzed using thematic analysis. Gamification and the Honeycomb model for user experience will be followed to achieve an appropriate technological solution that will be tested through a randomized controlled trial with at least 120 individuals. A mixed methods approach (quantitative/qualitative analysis) will be used to assess the feasibility and acceptability of the program. Open data and science, gender and ethical aspects, as well as a risk management plan are considered. A plan for communication, dissemination, exploitation of results will be considered. KOKU Bladder will be highly scalable and will have wide reach and impact. This proposal is in line with EU policy initiatives on Active and Healthy Ageing (bladder health and continence will be promoted), targeting aspects such as eHealth, Innovation and Digital Care Transformation, by supporting users to demand more responsive and integrated care programs for chronic conditions and enhancing self-management strategies, independence and health intelligence.

Conditions

Urinary Incontinence in Old Age

Keywords

pelvic health; urinary incontinence; aged; eHealth; behavior change; physical activity; sedentary behavior; bladder health; technology

Outcome Measures

Primary Outcomes (1)

• To co-create, develop and test an evidence based digital health program with behavior change techniques to decrease UI of community-dwelling adults aged 50 and over

  The primary aim of KOKU Bladder is to co-create and test an eHealth program to address bladder health (specifically urinary incontinence) in community-dwelling adults aged 50 and over

  3 years

Secondary Outcomes (5)

• To evaluate the life-impact related to UI (Incontinence Impact Questionnaire-7) of community-dwelling adults aged 50 and over.

  3 years

• To evaluate the lower urinary tract symptoms (International Prostate Symptom Score) of community-dwelling adults aged 50 and over.

  3 years

• To evaluate the Patient Global Impression of Improvement; SB (visual analogue scale, a 7-day recall period) of community-dwelling adults aged 50 and over

  3 years

• To evaluate the satisfaction with treatment of community-dwelling adults aged 50 and over.

  3 years

• To modify the severity of UI (International Consultation on Incontinence Questionnaire-UI short form) of community-dwelling adults aged 50 and over

  3 years

Study Arms (2)

control group

ACTIVE COMPARATOR

The control group which will receive recommendations for self- managing urinary symptoms. There will be at least 60 participants (men and women mixed) distributed in 3 countries. It is anticipated that the multicomponent intervention will last 12 weeks. After the intervention we will collect the results with a mixed (qualitative and quantitative) approach.

Behavioral: recommendations

intervention group

EXPERIMENTAL

The intervention group, which will receive the treatment with KOKU Bladder. There will be at least 60 participants (men and women mixed) distributed in 3 countries. It is anticipated that the multicomponent intervention will last 12 weeks. After the intervention we will collect the results with a mixed (qualitative and quantitative) approach.

Behavioral: KOKU Bladder

Interventions

KOKU Bladder BEHAVIORAL

In this intervention the participants will receive treatment with the KOKU app ( based digital health program with behavior change techniques to improve bladder health ) for 12 weeks. After the intervention we will collect the results with a mixed (qualitative and quantitative) approach. Qualitative information will be recorded and analysed through thematic analysis, and quantitative data will be collected with tests and questionnaires.

intervention group

recommendations BEHAVIORAL

In this intervention the participants will receive recommendations for self- managing urinary symptoms, which they must follow for 12 weeks. After the intervention we will collect the results with a mixed (qualitative and quantitative) approach. Qualitative information will be recorded and analysed through thematic analysis, and quantitative data will be collected with tests and questionnaires.

control group

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Red-flag symptoms (e.g., bleeding)
• Unstable health conditions.

Sponsors & Collaborators

• University of Vic - Central University of Catalonia: lead
• Hospital Universitari Santa Maria de Lleida (GSS): collaborator
• Institut de Recerca i Innovació en Ciències de la Vida i de la Salut a la Catalunya Central (IRIS): collaborator
• University of Manchester: collaborator
• Research Council of Lithuania: collaborator
• Lithuanian Sports University: collaborator
• Agencia Gestió Ajuts Universitaris i Recerca: collaborator
• Consorci Hospitalari de Vic (CHV): collaborator

Study Sites (4)

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

Related Publications (1)

• Jerez-Roig J, Aguila-Gimeno O, Brazaitis M, Solianik R, Karkauskiene E, Jarutiene L, Fuente-Vidal A, Borralleras-Fumana E, Gasteiger N, Stanmore E. Co-creating and testing a self-management digital solution for bladder health and urinary continence among people aged 50 and over: protocol for the international KOKU Bladder project. BMJ Open. 2025 Sep 11;15(9):e100487. doi: 10.1136/bmjopen-2025-100487.

  PMID: 40940057 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Motor Activity; Sedentary Behavior

Interventions

Health Planning Guidelines

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations

Study Officials

• Jerez-Roig, PhD

  University of Vic-Central University of Catalonia; Lithuanian Sports University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Jerez-Roig, Professor, PhD

CONTACT

+34 93 881 60 25; javier.jerez@uvic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Usually, in physiotherapist studies it is very difficult to do blinding, because the patients can do some physical activity or exercise. In this trial, participants blinding will not be possible because the patients know what treatment they do, they should do the different exercises with app or with a HB information. Also, it is necessary to do face-to-face assessment for the physiotherapist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of research group on Methodology, Methods, Models and Outcomes of Health and Social Science (M3O)

Model Details: 120 individuals will be simple randomised to a control (recommendations for self- managing urinary symptoms) or intervention (KOKU Bladder) group. It is anticipated that the multicomponent intervention will last 12 weeks and consist of health education, pelvic floor muscle exercises and BC techniques but this may vary according to the co-creation process. Measures will be assessed at baseline and end of intervention.

Study Record Dates

• First Submitted: September 1, 2024
• First Posted: September 4, 2024
• Study Start: March 24, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

ES (2); GB (1); LI (1)