Overactive Bladder Clinical Trial
— DOABOfficial 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. 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.
| Status | Not yet recruiting |
| Enrollment | 1000 |
| Est. completion date | December 2025 |
| Est. primary completion date | December 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - OAB - Adult Exclusion Criteria: - SNM or Botox in history |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Ghent University Hospital | Ghent | East-Fanders |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Ghent | Algemeen Ziekenhuis Maria Middelares, AZ Jan Palfijn Gent, AZ Sint-Lucas Gent |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Discrete choice questionnaire | Patients choose between two fictive therapies, each option comes with it's own botox and sacral neurmodulator (SNM) characteristics | 1 hour |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04578899 -
"The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity"
|
N/A | |
| Active, not recruiting |
NCT03556891 -
Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence
|
N/A | |
| Not yet recruiting |
NCT05977634 -
Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder
|
N/A | |
| Completed |
NCT01955408 -
Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment
|
N/A | |
| Recruiting |
NCT06201013 -
Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children
|
N/A | |
| Recruiting |
NCT03727711 -
TPTNS: Home vs Hospital Treatment for Overactive Bladder
|
N/A | |
| Completed |
NCT00768521 -
A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)
|
Phase 1 | |
| Completed |
NCT03625843 -
Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing
|
N/A | |
| Completed |
NCT02211846 -
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder
|
Phase 1 | |
| Completed |
NCT02857816 -
PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB
|
N/A | |
| Completed |
NCT02835846 -
Investigation of the Effect of the Female Urinary Microbiome on Incontinence
|
Phase 4 | |
| Completed |
NCT02202031 -
Controlling Urgency Through Relaxation Exercises
|
N/A | |
| Withdrawn |
NCT02320201 -
Foot Neuromodulation for Overactive Bladder in Children
|
N/A | |
| Not yet recruiting |
NCT01409512 -
Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder
|
N/A | |
| Not yet recruiting |
NCT01423838 -
Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder
|
Phase 4 | |
| Completed |
NCT01458197 -
A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder.
|
Phase 2 | |
| Completed |
NCT01437670 -
Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin
|
N/A | |
| Withdrawn |
NCT01210859 -
Effects of Antimuscarinic Drugs on Overactive Bladder (OAB) Symptoms After Insertion of Ureteral Stents
|
N/A | |
| Terminated |
NCT01758848 -
Physical Therapy for Overactive Bladder
|
N/A | |
| Terminated |
NCT01003249 -
Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen
|
Phase 4 |