Diversity in Patients With OAB

NCT05903105 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2024-10-30

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

Questionnaires

Patients fill in a questionnaire

Sponsors & Collaborators

  • AZ Sint-Lucas Gent

    collaborator OTHER
  • AZ Jan Palfijn Gent

    collaborator OTHER
  • Algemeen Ziekenhuis Maria Middelares

    collaborator OTHER
  • University Hospital, Ghent

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05903105 on ClinicalTrials.gov