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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07545148
Acronym
REVEAL-OAB
Enrollment
2000
Registered
2026-04-22
Start date
2026-07-01
Completion date
2027-02-01
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder (OAB), Overactive Bladder Syndrome

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

Brief 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.

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.

Interventions

None listed

Sponsors

European Association of Urology Research Foundation
Lead SponsorOTHER
Medtronic
CollaboratorINDUSTRY
Astellas Pharma Europe B.V.
CollaboratorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Sexual mattersPast four weeksParticipants 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 frequencyPast four weeksParticipants 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 symptomsPast four weeks1 is equivalent to 'none of the time' and 6 is equivalent to 'all of the time'

Contacts

CONTACTJoan E. Robijn
e.robijn@uroweb.org+31263890680
CONTACTTiina Vaittinen, PhD
tiina@goodmess.global+358(0)503745945
PRINCIPAL_INVESTIGATOREamonn T. Rogers, M Ch M Med Sci FRCSI FRCS(Urol

University College Hospital, Galway, Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026