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
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- European Association of Urology Research Foundation
- Enrollment
- 2,000
- Primary Endpoint
- Sexual matters
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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: Pats 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'
Secondary Outcomes
No secondary outcomes reported