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NCT Number: NCT06583733

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

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.

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Key information

Conditions

Urinary Incontinence in Old Age Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Motor Activity Pathological Conditions, Signs and Symptoms Sedentary Behavior Signs and Symptoms Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lithuanian Sports University, Kaunas, Lithuania

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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

    Time frame: 3 years

    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

Secondary outcomes

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

    Time frame: 3 years

    We will use the Incontinence Impact Questionnaire-7 (IIQ-7) to assess it

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

    Time frame: 3 years

    We will use different questionnaires.

  3. 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

    Time frame: 3 years

    We will use a visual analogue scale to assess it

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

    Time frame: 3 years

    We will use different questionnaires.

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

    Time frame: 3 years

    We will use the International Incontinence Questionnaire-Short Form (ICIQ-SF) to assess it

Study contacts

Contact information is provided by the study sponsor or research team.

Javier Jerez-Roig, Professor, PhD

CONTACT

[email protected]

+34 93 881 60 25

Sponsors and collaborators

Lead sponsor

University of Vic - Central University of Catalonia

Other

Collaborators

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

Registry information

Official study title

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

Acronym: KOKU Bladder

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 4, 2024
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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