Page 120 - Bladder Dysfunction in the Context of the Bladder-Brain Connection - Ilse Groenendijk.pdf

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Chapter 6
MATERIALS AND METHODS
Study design
This is a single-center, prospective cohort validation study, for which approval was obtained by the Ethics Review Board.
Patient group
All patients seen at the Urology outpatient clinic in between April 2018 and February 2019 diagnosed with OAB were eligible for screening. OAB was defined as urinary urgency, with or without urinary incontinence. Inclusion criteria were age ≥18 years and being flu- ent and literate in the Dutch language. Exclusion criteria consisted of urinary diversions, a history of/or active malignant tumors of the urinary tract, hematuria, bladder stones, neurogenic bladder, dementia, mental retardation and symptomatic urinary tract infec- tion. The treating physician explained the study to patients eligible for inclusion and invited to participate. After signing informed consent patients were asked to complete the questionnaires during the inclusion visit (test) and 2 weeks later at home (retest). Characteristics of the included patients were extracted from the medical records.
Reference group
Patients who visited the department of Allergology outpatient clinic between Septem- ber 2019 and December 2019 were invited as reference group. Inclusion criteria were age ≥18 years and being fluent and literate in the Dutch language. Exclusion criteria consisted of a urological medical history or current bladder problems, dementia and mental retardation. We considered these patients as a proper control group as allergy pathology has no relationship with bladder problems; those with bladder problems were indeed not eligible for inclusion in the reference group. Patients who met inclusion criteria were informed by their treating physician and if willing to participate, informed consent was signed and one set of questionnaires was completed.
Questionnaires
The questionnaire set included 4 questionnaires: the OAB-q SF, the EQ-5D-5L, the Uro- genital Distress Inventory 6 (UDI-6) and the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB).
- The OAB-q SF is a 19-item, self-administered disease specific instrument derived
from the OAB-q.9,10 The OAB-q SF contains two main subscales: Symptom bother (6 items) and Health Related Quality of Life (HRQOL, 13 items). Each item is rated on a six-point Likert scale, for the symptom bother scale ranging from 0 (not at all) to 6 (a very great deal) and for the HRQOL scale from 0 (none of the time) to 6 (all of the time). The two subscales are separately summed and, on the guidance of the