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)

April 30, 2026 updated by: European Association of Urology Research Foundation

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Past four weeks
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'
Past four weeks
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)
Past four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Association of Urology Research Foundation

Collaborators

Medtronic
Astellas Pharma Europe B.V.

Investigators

  • Principal Investigator: Eamonn T. Rogers, M Ch M Med Sci FRCSI FRCS(Urol, University College Hospital, Galway, Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100983

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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