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

NCT07545148 — Not yet recruiting, 2000 participants, European Association of Urology Research Foundation

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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

RegistryNCT07545148, acronym REVEAL-OAB
StatusNot yet recruiting
Study typeObservational
Enrollment2000 (Estimated)
SponsorEuropean Association of Urology Research Foundation (Other); collaborators: Medtronic, Astellas Pharma Europe B.V.
ConditionsOveractive Bladder (OAB), Overactive Bladder Syndrome
Datesstart 2026-07-01 (estimated), primary completion 2026-11-01 (estimated), completion 2027-02-01 (estimated), first posted 2026-04-22, last updated 2026-05-06

Related Papers Related Patents Related Grants Related Experts
All trials for Overactive Bladder (OAB) All trials for Overactive Bladder Syndrome

-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.

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+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.

+Outcome measures

Primary outcomes

  • Sexual matters [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 [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 [Past four weeks]: 1 is equivalent to 'none of the time' and 6 is equivalent to 'all of the time'

+Eligibility

Sex: All, ages: 18 Years to any

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

+Investigators