Diversity in Patients With OAB

NCT05903105 | Not Yet Recruiting DMC

• 1 other identifier: ONZ-2023-0337
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Discrete choice questionnaire

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

  1 hour

Study Arms (1)

Overactive Bladder

Adult patients with overactive bladder

Other: Questionnaires

Interventions

Questionnaires OTHER

Patients fill in a questionnaire

Overactive Bladder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• OAB
• Adult

You may not qualify if:

• SNM or Botox in history

Sponsors & Collaborators

• University Hospital, Ghent: lead
• AZ Sint-Lucas Gent: collaborator
• AZ Jan Palfijn Gent: collaborator
• Algemeen Ziekenhuis Maria Middelares: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, East-Fanders, 9000, Belgium

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Irina Verbakel

CONTACT

003293322276; irina.verbakel@ugent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: June 15, 2023
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 30, 2024

Record last verified: 2024-10

Locations

BE (1)