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Diversity in Patients With OAB

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05903105
Acronym
DOAB
Enrollment
1000
Registered
2023-06-15
Start date
2025-01-31
Completion date
2025-12-31
Last updated
2024-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Discrete Choice Experiment, Diversity, Onabotulinum Toxin A, Overactive Bladder, Sacral Neuromodulation

Brief 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. 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. 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.

Interventions

OTHERQuestionnaires

Patients fill in a questionnaire

Sponsors

AZ Sint-Lucas Gent
CollaboratorOTHER
AZ Jan Palfijn Gent
CollaboratorOTHER
Algemeen Ziekenhuis Maria Middelares
CollaboratorOTHER
University Hospital, Ghent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* OAB * Adult

Exclusion criteria

* SNM or Botox in history

Design outcomes

Primary

MeasureTime frameDescription
Discrete choice questionnaire1 hourPatients choose between two fictive therapies, each option comes with it's own botox and sacral neurmodulator (SNM) characteristics

Countries

Belgium

Contacts

Primary ContactIrina Verbakel
irina.verbakel@ugent.be003293322276

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026