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NCT Number: NCT07545148

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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)

  3. 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'

Study contacts

Contact information is provided by the study sponsor or research team.

Joan E. Robijn

CONTACT

[email protected]

+31263890680

Tiina Vaittinen, PhD

CONTACT

[email protected]

+358(0)503745945

Sponsors and collaborators

Lead sponsor

European Association of Urology Research Foundation

Other

Collaborators

  • Astellas Pharma Europe B.V.
  • Medtronic

Registry information

Official study 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

Acronym: REVEAL-OAB

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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