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Not yet recruitingNCT07545148REVEAL-OABUpdated May 6, 2026

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

An observational study in Overactive Bladder (OAB) and Overactive Bladder Syndrome, sponsored by European Association of Urology Research Foundation. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by European Association of Urology Research Foundation · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
2,000
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • 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
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
2,000 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Sexual matters

    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)

    Time frame: Past four weeks

  2. OAB symptom severity and frequency

    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)

    Time frame: Past four weeks

  3. Quality of Life relating to bladder symptoms

    1 is equivalent to 'none of the time' and 6 is equivalent to 'all of the time'

    Time frame: Past four weeks

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Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07545148
Lead sponsor
European Association of Urology Research Foundation
Collaborators
Medtronic, Astellas Pharma Europe B.V.
Responsible party
Sponsor
First posted
Apr 22, 2026
Start date
Jul 1, 2026 (estimated)
Primary completion
Nov 1, 2026 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
May 6, 2026

Study contacts

Joan E. Robijn
Contact
e.robijn@uroweb.org
+31263890680
Tiina Vaittinen, PhD
Contact
tiina@goodmess.global
+358(0)503745945
Eamonn T. Rogers, M Ch M Med Sci FRCSI FRCS(Urol
principal investigator · University College Hospital, Galway, Ireland

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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