Overactive Bladder (OAB)REVEAL-OABNCT07545148
Real-world Experiences and Voices Exploring the Actual Lived Burden of OAB: A Mixed-methods Multi-country PROMs Study on OAB Patients' Quality of Life
An observational study of Overactive Bladder (OAB) and Overactive Bladder Syndrome, run by European Association of Urology Research Foundation.
Trial summary
The main goal is to understand what it is truly like to live with OAB from the patient's perspective, including how it affects: daily activities, emotional wellbeing and mental health, social life and relationships, work and overall quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder (OAB), Overactive Bladder Syndrome
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Feb 2027
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CHU Grenoble Alpes, France; Tenon Academic Hospital Paris, France; Universitätsklinikum Münster, Germany; Fondazione Policlinico Universitario Campus Bio-Medico of Rome Italy; Policlinico Tor Vergata University Hospital, Rome Italy; Urology Clinic at the Orlowski Hospital in Warsaw, Poland; Hospital Universitario Vitgen De Valme, Seville Spain; Complejo Hospitalario Universitario Insular Materno Infantil (CHUIMI), Gran Canaria Spain; Karolinska Institutet Solna, Stockholm Area, Sweden; Rijnstate Hospital Arnhem, the Netherlands, Maastricht UMC, the Netherlands; Sheffield Teaching Hospitals NHS Trust, Sheffield, UK.
Who may be able to join
- If they are over 18 years old.
- They have been told by a doctor or other healthcare professional that they have symptoms that match OAB, or have been given a diagnosis of OAB.
- They live in France, Germany, Italy, the Netherlands, Poland, Spain, Sweden, or the UK.
- They have received the Patient Information Sheet from their health care provider, during an appointment, via email, or postal mail.
- They can confirm they understand the Patient Information Sheet and that they want to take part in this study.
Who cannot join
- They have not received information on this study from their own health care provider
- They have a confirmed neurological condition known to affect bladder function (for example: multiple sclerosis, Parkinson's disease, spinal cord injury).
- They have undergone major surgery directly involving the bladder, prostate, urethra, or pelvic structures that affect urinary function.
- They presently have a urinary tract infection (UTI).
- They have or have had cancer in their bladder, kidneys, prostate, or other urinary or reproductive organs
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: REVEAL-OAB. Real-world Experiences and Voices Exploring the Actual Lived Burden of OAB: A Mixed-methods Multi-country PROMs Study on OAB Patients' Quality of Life
The main goal is to understand what it is truly like to live with OAB from the patient's perspective, including how it affects: daily activities, emotional wellbeing and mental health, social life and relationships, work and overall quality of life.
Read the detailed description
The REVEAL-OAB (Real-world Experiences and Voices Exploring the Actual Lived burden of Overactive Bladder) study is a large, international, mixed-methods research program designed to capture both the measurable burden and the lived experience of overactive bladder (OAB).Quantitatively, it uses structured surveys and validated patient-reported outcome measures to assess symptom severity (e.g., urgency, frequency, incontinence), health-related quality of life, healthcare utilization, and treatment patterns across diverse populations. Qualitatively, it incorporates in-depth patient interviews, open-ended survey responses, and narrative data to explore how OAB affects emotional wellbeing, social functioning, relationships, and daily decision-making. By integrating these quantitative metrics with rich qualitative insights, the study aims to provide a comprehensive, patient-centered understanding of OAB, identify unmet needs in care, and inform more effective clinical management and health policy.
- Keywords
- Real-world evidence;, Patient-centred research, Mixed-method study, International, multi-country study, Observational study, Overactive bladder (OAB) burden, Quality of life (QoL), Emotional and psychosocial impact, Quantitative surveys, Patient-reported outcomes (PROs), Qualitative interviews, Evidence to inform clinical practice and policy, Unmet needs in care, Real-life disease impact, Symptom impact and severity, Lived patient experience
- Medical subject headings
- Urinary Bladder, Overactive
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual matters
Participants achieved a response if they scored a bother status of 0 or 1 on a scale ranging from 0 (not at all) to 10 (a lot)
Measured: Past four weeks
OAB symptom severity and frequency
Participants achieved a response if they scored a bother status of 0 or 1 on a scale ranging from 0 (not at all) to 10 (a great deal)
Measured: Past four weeks
Quality of Life relating to bladder symptoms
1 is equivalent to 'none of the time' and 6 is equivalent to 'all of the time'
Measured: Past four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Association of Urology Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Astellas Pharma Europe B.V.
- Responsible party
- Sponsor
- Investigators
- Eamonn T. Rogers, M Ch M Med Sci FRCSI FRCS(Urol, Principal investigator, University College Hospital, Galway, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545148
- Sponsor's protocol ID
- 100983
- Acronym
- REVEAL-OAB
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REVEAL-OAB. Real-world Experiences and Voices Exploring the Actual Lived Burden of OAB: A Mixed-methods Multi-country PROMs Study on OAB Patients' Quality of Life
- ClinicalTrials.gov ID
- NCT07545148
- Acronym / sponsor ID
- REVEAL-OAB / 100983
- Keywords
- Real-world evidence;, Patient-centred research, Mixed-method study, International, multi-country study, Observational study, Overactive bladder (OAB) burden, Quality of life (QoL), Emotional and psychosocial impact
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- European Association of Urology Research FoundationUniversity, hospital or other
- Collaborators
- Medtronic, Astellas Pharma Europe B.V.
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 22 Apr 2026 (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.
The main goal is to understand what it is truly like to live with OAB from the patient's perspective, including how it affects: daily activities, emotional wellbeing and mental health, social life and relationships, work and overall quality of life.
Detailed description
The REVEAL-OAB (Real-world Experiences and Voices Exploring the Actual Lived burden of Overactive Bladder) study is a large, international, mixed-methods research program designed to capture both the measurable burden and the lived experience of overactive bladder (OAB).Quantitatively, it uses structured surveys and validated patient-reported outcome measures to assess symptom severity (e.g., urgency, frequency, incontinence), health-related quality of life, healthcare utilization, and treatment patterns across diverse populations. Qualitatively, it incorporates in-depth patient interviews, open-ended survey responses, and narrative data to explore how OAB affects emotional wellbeing, social functioning, relationships, and daily decision-making. By integrating these quantitative metrics with rich qualitative insights, the study aims to provide a comprehensive, patient-centered understanding of OAB, identify unmet needs in care, and inform more effective clinical management and health policy.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CHU Grenoble Alpes, France; Tenon Academic Hospital Paris, France; Universitätsklinikum Münster, Germany; Fondazione Policlinico Universitario Campus Bio-Medico of Rome Italy; Policlinico Tor Vergata University Hospital, Rome Italy; Urology Clinic at the Orlowski Hospital in Warsaw, Poland; Hospital Universitario Vitgen De Valme, Seville Spain; Complejo Hospitalario Universitario Insular Materno Infantil (CHUIMI), Gran Canaria Spain; Karolinska Institutet Solna, Stockholm Area, Sweden; Rijnstate Hospital Arnhem, the Netherlands, Maastricht UMC, the Netherlands; Sheffield Teaching Hospitals NHS Trust, Sheffield, UK.
Key inclusion criteria (5 listed)
- If they are over 18 years old.
- They have been told by a doctor or other healthcare professional that they have symptoms that match OAB, or have been given a diagnosis of OAB.
- They live in France, Germany, Italy, the Netherlands, Poland, Spain, Sweden, or the UK.
- They have received the Patient Information Sheet from their health care provider, during an appointment, via email, or postal mail.
- They can confirm they understand the Patient Information Sheet and that they want to take part in this study.
Key exclusion criteria (5 listed)
- They have not received information on this study from their own health care provider
- They have a confirmed neurological condition known to affect bladder function (for example: multiple sclerosis, Parkinson's disease, spinal cord injury).
- They have undergone major surgery directly involving the bladder, prostate, urethra, or pelvic structures that affect urinary function.
- They presently have a urinary tract infection (UTI).
- They have or have had cancer in their bladder, kidneys, prostate, or other urinary or reproductive organs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sexual matters
Time frame: Past four weeks
Participants achieved a response if they scored a bother status of 0 or 1 on a scale ranging from 0 (not at all) to 10 (a lot)
OAB symptom severity and frequency
Time frame: Past four weeks
Participants achieved a response if they scored a bother status of 0 or 1 on a scale ranging from 0 (not at all) to 10 (a great deal)
Quality of Life relating to bladder symptoms
Time frame: Past four weeks
1 is equivalent to 'none of the time' and 6 is equivalent to 'all of the time'
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 6 May 2026.
- REVEAL-OAB webpage under constructionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Eamonn T. Rogers, M Ch M Med Sci FRCSI FRCS(Urol principal investigator
University College Hospital, Galway, Ireland
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder (OAB) and Overactive Bladder Syndrome, run by European Association of Urology Research Foundation.
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 5 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: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Joan E. Robijn (+31263890680, e.robijn@uroweb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual matters (time frame: Past four weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2026.