Urinary Incontinence in Old AgeKOKU BladderNCT06583733
Keep On Keep Up Bladder Health: Co-creating and Testing a Self-management Technological Solution for Ageing Well
A study testing KOKU Bladder and recommendations in people with Urinary Incontinence in Old Age, run by University of Vic - Central University of Catalonia at 4 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Urinary Incontinence in Old Age
- What is being tested?
- KOKU Bladder and recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 24 Mar 2025to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Red-flag symptoms (e.g., bleeding)
- Unstable health conditions.
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Spain2 sites, 2 recruiting
- Recruiting
Hospital Santa Maria
Lleida
Oscar Águila, PhD student, 973 72 72 22, oscarkinelleida@gmail.com
- Recruiting
Hospital Consortium of Vic
Vic
Eva Borralleras-Fumaña
Lithuania1 site, 1 recruiting
- Recruiting
Lithuanian Sports University
Kaunas
Marius Brazaitis, PhD, Professor, 8-670-59637, marius.brazaitis@lsu.lt
United Kingdom1 site, 1 recruiting
- Not yet recruiting
University of Manchester
Manchester
Emma Stanmore, PhD, +44 (0) 161 306 600, emma.stanmore@manchester.ac.uk
About this study
Official 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
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.
Read the 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.
- Conditions
- Urinary Incontinence in Old Age
- Being tested
- KOKU Bladder, recommendations
- Keywords
- pelvic health, urinary incontinence, aged, eHealth, behavior change, physical activity, sedentary behavior, bladder health, technology
- Medical subject headings
- Urinary Incontinence, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KOKU BladderBehavioural
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.
recommendationsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: KOKU Bladder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
We will use the Incontinence Impact Questionnaire-7 (IIQ-7) to assess it
Measured: 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.
Measured: 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
Measured: 3 years
To evaluate the satisfaction with treatment of community-dwelling adults aged 50 and over.
We will use different questionnaires.
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start24 Mar 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Incontinence in Old AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vic - Central University of Catalonia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari Santa Maria, Spain, Institut de Recerca i Innovació en Ciències de la Vida i de la Salut a la Catalunya Central (IRIS), University of Manchester, Research Council of Lithuania, Lithuanian Sports University, Agencia Gestió Ajuts Universitaris i Recerca, Consorci Hospitalari de Vic
- Responsible party
- Principal investigator, Javier Jerez Roig, University of Vic - Central University of Catalonia
- Investigators
- Jerez-Roig, PhD, Principal investigator, University of Vic-Central University of Catalonia; Lithuanian Sports University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583733
- Sponsor's protocol ID
- KOKU Bladder
- Acronym
- KOKU Bladder
- Status last verified
- Mar 2025
- First submitted
- 1 Sep 2024
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40940057
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06583733
- Acronym / sponsor ID
- KOKU Bladder / KOKU Bladder
- Conditions
- Urinary Incontinence in Old Age
- Keywords
- pelvic health, urinary incontinence, aged, eHealth, behavior change, physical activity, sedentary behavior, bladder health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Vic - Central University of CataloniaUniversity, hospital or other
- Collaborators
- Hospital Universitari Santa Maria, Spain, Institut de Recerca i Innovació en Ciències de la Vida i de la Salut a la Catalunya Central (IRIS), University of Manchester, Research Council of Lithuania, Lithuanian Sports University, Agencia Gestió Ajuts Universitaris i Recerca, Consorci Hospitalari de Vic
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 4 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Behavioral: recommendationsThe 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. |
| intervention group | Experimental | Behavioral: KOKU BladderThe 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. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Red-flag symptoms (e.g., bleeding)
- Unstable health conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KOKU BladderIn 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. | Behavioural | intervention group |
| recommendationsIn 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. | Behavioural | control group |
Primary outcome
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
5 secondary outcomes
To evaluate the life-impact related to UI (Incontinence Impact Questionnaire-7) of community-dwelling adults aged 50 and over.
Time frame: 3 years
To evaluate the lower urinary tract symptoms (International Prostate Symptom Score) of community-dwelling adults aged 50 and over.
Time frame: 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
Time frame: 3 years
To evaluate the satisfaction with treatment of community-dwelling adults aged 50 and over.
Time frame: 3 years
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 40940057Jerez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jerez-Roig, PhD principal investigator
University of Vic-Central University of Catalonia; Lithuanian Sports University
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KOKU Bladder and recommendations in people with Urinary Incontinence in Old Age, run by University of Vic - Central University of Catalonia at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, Lithuania, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Javier Jerez-Roig, Professor, PhD (+34 93 881 60 25, javier.jerez@uvic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06583733, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.