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 DMC

• 1 other identifier: 100983
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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)

  Past four weeks

• 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)

  Past four weeks

• Quality of Life relating to bladder symptoms

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

  Past four weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• European Association of Urology Research Foundation: lead
• Medtronic: collaborator
• Astellas Pharma Europe B.V.: collaborator

Related Links

• REVEAL-OAB webpage under construction

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eamonn T. Rogers, M Ch M Med Sci FRCSI FRCS(Urol

  University College Hospital, Galway, Ireland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joan E. Robijn

CONTACT

+31263890680; e.robijn@uroweb.org

Tiina Vaittinen, PhD

CONTACT

+358(0)503745945; tiina@goodmess.global

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share