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

On Any Page, Select Quit to Stop Entering Data. Data Entered on Previous Pages Will be Retained: To Complete Data Entry Later, Open the Record From the Home Page

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence in Old Age
• Intervention / Treatment: Behavioral: recommendations; Behavioral: KOKU Bladder

Detailed Description

Phase I (month-M1-3): Prepare and submit protocol to Ethics Committee, conduct an updated review of the on eHealth solutions to manage UI using BCTs (e.g. training, education) that have been designed or tested in older adults, and establish contact with the Lithuanian, Spanish and UK participating institutions. Phase1 is dedicated to the management of the project throughout its duration.

Phase II (M2-5): Consultation with 4-6 experts on Badder Health (BH) and/or behavioral interventions. Develop a first iteration of the eHealth method and module.

Conduct an initial online focus group with 10-12 co-creators of UK to explore their perceived acceptability and feasibility and preferences for the eHealth program (concept development through co-creation).

Develop a first iteration of the eHealth method and module (concept development) - by Reason Digital (tech company in Manchester)

Phase III (M6-14): Organize, conduct and analyze 5 more focus group (2 in Lithuania, 1 UK and 2 Spain) with 10-12 co-creators each (community-dwelling people aged 50+ of both genders with different physical conditions and UI, health professionals and stakeholders with different backgrounds) to explore their perceived acceptability and feasibility and preferences for the eHealth program (concept development through co-creation). Secondment in University of Manchester.

Phase IV (M14-M20): Further develop the eHealth module (concept development) - by Reason Digital (tech company in Manchester)

Phase V (M21-36): Multicenter two-armed feasibility RCT study with at least 120 participants (WP3). Participants will be randomized to a control (recommendations for self- managing urinary symptoms) or intervention (KOKU Bladder) group.

Phase VI: Early and open communication and dissemination (WP4). Analysis of results.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Javier Jerez-Roig, Professor, PhD; Phone Number: +34 93 881 60 25; Email: javier.jerez@uvic.cat

Study Locations

• Lithuania
  • Kaunas, Lithuania
    • Recruiting
    • Lithuanian Sports University
    • Contact: Marius Brazaitis, PhD, Professor; Phone Number: 8-670-59637; Email: marius.brazaitis@lsu.lt
• Spain
  • Lleida, Spain
    • Recruiting
    • Hospital Santa Maria
    • Contact: Oscar Águila, PhD student; Phone Number: 973 72 72 22; Email: oscarkinelleida@gmail.com
  • Vic, Spain
    • Recruiting
    • Hospital Consortium of Vic
    • Contact: Eva Borralleras-Fumaña
• United Kingdom
  • Manchester, United Kingdom
    • Not yet recruiting
    • University of Manchester
    • Contact: Emma Stanmore, PhD; Phone Number: +44 (0) 161 306 600; Email: emma.stanmore@manchester.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; 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; 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.
Experimental: intervention group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the life-impact related to UI (Incontinence Impact Questionnaire-7) of community-dwelling adults aged 50 and over.	We will use the Incontinence Impact Questionnaire-7 (IIQ-7) to assess it	3 years
To evaluate the lower urinary tract symptoms (International Prostate Symptom Score) of community-dwelling adults aged 50 and over.	We will use different questionnaires.	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	We will use a visual analogue scale to assess it	3 years
To evaluate the satisfaction with treatment of community-dwelling adults aged 50 and over.	We will use different questionnaires.	3 years
To modify the severity of UI (International Consultation on Incontinence Questionnaire-UI short form) of community-dwelling adults aged 50 and over	We will use the International Incontinence Questionnaire-Short Form (ICIQ-SF) to assess it	3 years

Collaborators and Investigators

• Sponsor: University of Vic - Central University of Catalonia
• Collaborators: University of Manchester; Lithuanian Sports University; Research Council of Lithuania; Hospital Universitari Santa Maria de Lleida (GSS); Institut de Recerca i Innovació en Ciències de la Vida i de la Salut a la Catalunya Central (IRIS); Agencia Gestió Ajuts Universitaris i Recerca; Consorci Hospitalari de Vic (CHV)
• Investigators: Principal Investigator: Jerez-Roig, PhD, University of Vic-Central University of Catalonia; Lithuanian Sports University

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: September 1, 2024
• First Submitted That Met QC Criteria: September 3, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: physical activity; eHealth; sedentary behavior; technology; aged; urinary incontinence; behavior change; pelvic health; bladder health
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: KOKU Bladder

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No