Clinical trial NCT05903105: Diversity in Patients With OAB
Official title: The Preference of a Culturally and Linguistic Diverse (CALD) Population for Second Line OAB Therapy: a Discrete Choice Experiment
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Overactive Bladder
Diversity
Onabotulinum Toxin A
Sacral Neuromodulation
Discrete Choice Experiment
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: AZ Sint-Lucas Gent
name: AZ Jan Palfijn Gent
name: Algemeen Ziekenhuis Maria Middelares
First posted: 2023-06-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: Inclusion Criteria:

* OAB
* Adult

Exclusion Criteria:

* SNM or Botox in history

Primary outcomes:
measure: Discrete choice questionnaire
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: East-Fanders
Study officials:
References: