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Overactive BladderDOABNCT05903105

Diversity in Patients With OAB

An observational study of Overactive Bladder and Diversity, run by University Hospital, Ghent at 1 site in Belgium.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

An overactive bladder (OAB) is a condition characterized by frequent en nightly voiding, small bladder capacity and the occurrence of sudden urge to void, with or without urinary incontinence. The prevalence of OAB with bothersome complaints is around 11% in women and 9% in men with an increasing incidence with age. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Questionnaires
How many people
1,000 participants
Where
1 siteBelgium
Study dates
Jan 2025to Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All adult patients with an overactive bladder are eligible to participate in the study. Patients who received intravesical botox or had/have a SNM implanted are not eligible.

Who may be able to join

  • OAB
  • Adult

Who cannot join

  • SNM or Botox in history

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Belgium1 site
  • Ghent University Hospital

    Ghent, East-Fanders, 9000

    Irina Verbakel, 003293322276, irina.verbakel@ugent.be

Other trials in Belgium

About this study

Official title: The Preference of a Culturally and Linguistic Diverse (CALD) Population for Second Line OAB Therapy: a Discrete Choice Experiment

An overactive bladder (OAB) is a condition characterized by frequent en nightly voiding, small bladder capacity and the occurrence of sudden urge to void, with or without urinary incontinence. The prevalence of OAB with bothersome complaints is around 11% in women and 9% in men with an increasing incidence with age. OAB is not an illness or disease but nevertheless had a significant impact on both the individual as society. First-line treatment for OAB consists out of behavioral and physiotherapy. Anticholinergic medication can be associated to improve bothersome symptoms, but has the downside of causing unwanted side effects. If the formentioned treatment is not sufficient, second line treatment can be discussed. Depending on the patient's characteristics and the physician's preference intravesical injections of Botox or the implantation of a sacral neuromodulator (SNM) can be considered.

Both options are equal and effective, but many individual differences exist in preference. Regarding outcome, some factors have been described to prefer one therapy above the other, for example in case of concomitant fecal incontinence, frequent urinary tract infections,… The personal preference of doctors and patients has been investigated, but currently no study has focused on therapy preference in a culturally and linguistic divers (CALD) population. The latter broadly describes a population with ethnical, cultural, religious and/or language characteristics and is a general accepted measure of diversity.

Read more

In the current study, the investigators aim to describe the different (dis)advantages of both second line treatments for OAB in a discrete choice experiment. The study population will consist of a diverse group of patients with OAB from different hospitals. The goal is to investigate if CALD patients make a different choice in treatment and what factors contribute to that decision in order to provide more tailored information regarding the treatment options in the future. Taking a patient's context into account in the shared decision making between a patient and physician increases therapy compliance and satisfaction of the chosen treatment.

The total questionnaire will consist out of general demographic info, the EQ-5D, the International Consultation on Incontinence Questionnaire (ICIQ)-OAB and the discrete choice questionnaire in which patients make a choice between two fictional treatment options consisting of a combination of different therapy characteristics. The questionnaire will be translated into different languages in order to lower the threshold for participation.

Being tested
Questionnaires
Medical subject headings
Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnairesOther

    Patients fill in a questionnaire

Study groups in NCT05903105
Study groupRoleWhat they receive
Overactive BladderAdult patients with overactive bladder
Receives: Other: Questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Discrete choice questionnaire

    Patients choose between two fictive therapies, each option comes with it's own botox and sacral neurmodulator (SNM) characteristics

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study startJan 2025 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05903105
Sponsor's protocol ID
ONZ-2023-0337
Acronym
DOAB
Status last verified
Oct 2024
First submitted
19 May 2023
Last updated
30 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Overactive Bladder and Diversity, run by University Hospital, Ghent at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Irina Verbakel (003293322276, irina.verbakel@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Discrete choice questionnaire (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.

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