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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Association of Urology Research Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial 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.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

European Association of Urology Research Foundation

Lead sponsor

Medtronic

Collaborator

Astellas Pharma Europe B.V.

Collaborator

This trial is not recruiting at the moment. You can still explore other options: