Lower Urinary Tract Symptoms (LUTS)
Conditions
Keywords
Urodynamics, Anxiety, Running water sound, Maximum flow rate
Brief summary
This study aims to see if listening to recorded running water sounds during a bladder function test (urodynamic study) helps patients feel calmer and makes it easier for them to empty their bladder during the test. Bladder tests can cause anxiety or discomfort, which sometimes affects results. Playing running water sounds may help patients relax and improve their experience, based on earlier research. Participants will be randomly placed into one of two groups. One group will listens to running water sounds during the test while the other group will have the test done in the usual way without additional auditory intervention. Participants rate their anxiety before, during, and after the test using simple scales. Parameters of the test will be recorded for analysis.
Interventions
BEHAVIORALAuditory intervention with running water sound
standardized audio via smartphone during pressure flow study
Sponsors
Princess Margaret Hospital, Hong Kong
Caritas Medical Centre, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Chinese women aged 18-90 years scheduled for urodynamic study. * Understand written traditional Chinese. * Willing to participate and provide a written informed consent.
Exclusion criteria
* Patients who refuse to participate or provide written consent. * Patients who do not understand or comprehend written traditional Chinese. * Patients with severe cognitive impairment or inability to complete the VAS. * Patients with known psychiatric conditions that may confound anxiety measurements. * Patients with hearing impairments that would prevent perception of the running water sound.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum urinary flow rate (Qmax) measured by urodynamic pressure-flow study | During the pressure-flow study phase of the urodynamic procedure | Maximum urinary flow rate (Qmax), defined as the peak flow rate during voluntary voiding with an indwelling catheter in place, measured in milliliters per second (mL/s) using standard urodynamic equipment. This parameter reflects bladder outlet function and is recorded automatically by the urodynamic system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety level before urodynamic procedure measured by Visual Analogue Scale (VAS) | Immediately before the start of the urodynamic procedure | Anxiety level assessed using the Visual Analogue Scale (VAS), a 10-cm horizontal line where 0 = no anxiety and 10 = extreme anxiety (higher scores indicate worse anxiety). Participants mark their current anxiety level immediately before the urodynamic procedure begins. |
| Anxiety level during pressure-flow study measured by Visual Analogue Scale (VAS) | During the pressure-flow study phase of the urodynamic procedure | Anxiety level assessed using the Visual Analogue Scale (VAS), a 10-cm horizontal line where 0 = no anxiety and 10 = extreme anxiety (higher scores indicate worse anxiety). Participants mark their anxiety level during the pressure-flow study phase of the urodynamic procedure (while listening to running water sound or in the control condition). |
| Anxiety level within 15 minutes after urodynamic procedure measured by Visual Analogue Scale (VAS) | Within 15 minutes after completion of the urodynamic procedure | Anxiety level assessed using the Visual Analogue Scale (VAS), a 10-cm horizontal line where 0 = no anxiety and 10 = extreme anxiety (higher scores indicate worse anxiety). Participants mark their current anxiety level within 15 minutes after completion of the urodynamic procedure. |
| Detrusor pressure at maximum flow rate (PdetQmax) measured by urodynamic pressure-flow study | During the pressure-flow study phase of the urodynamic procedure | Detrusor pressure at maximum flow rate (PdetQmax), defined as the detrusor pressure (in cmH₂O) recorded at the point of maximum urinary flow rate during voluntary voiding with an indwelling catheter in place. This is measured using simultaneous intravesical and intra-abdominal pressure transducers in the standard urodynamic pressure-flow study, and it reflects detrusor contractility and outlet resistance. |
| Proportion of participants able to micturate (void) during pressure-flow study phase | During the pressure-flow study phase of the urodynamic procedure | Proportion (percentage) of participants who successfully micturate (void urine) with an indwelling catheter in place during the pressure-flow study phase of the urodynamic procedure. This binary outcome (yes/no) is assessed and recorded by the urodynamicist based on direct observation and urodynamic system data (presence of urine flow \>0 mL/s during voluntary voiding attempt). It evaluates whether the auditory intervention (running water sound) facilitates voiding under catheterized conditions. |
| Bladder Outlet Obstruction Index (BOOI) calculated from urodynamic pressure-flow study | At the point of maximum urinary flow rate during the pressure-flow study | Bladder Outlet Obstruction Index (BOOI), a calculated index of bladder outlet obstruction, derived from the formula: BOOI = PdetQmax - (2 × Qmax), where PdetQmax is detrusor pressure at maximum flow rate (cmH₂O) and Qmax is maximum urinary flow rate (mL/s). Measured during the pressure-flow study phase using standard urodynamic equipment. Higher BOOI values indicate greater degree of bladder outlet obstruction (worse outcome). |
| Bladder Contractility Index (BCI) calculated from urodynamic pressure-flow study | At the point of maximum urinary flow rate during the pressure-flow study | Bladder Contractility Index (BCI), a calculated index of bladder contractility, derived from the formula: BCI = PdetQmax + (5 × Qmax), where PdetQmax is detrusor pressure at maximum flow rate (cmH₂O) and Qmax is maximum urinary flow rate (mL/s). Measured during the pressure-flow study phase using standard urodynamic equipment. Higher BCI values indicate stronger bladder contractility (better outcome). |
Countries
Hong Kong
Contacts
CONTACTSiu Chung Wong, MBBS
PRINCIPAL_INVESTIGATORSiu Chung Wong
Princess Margaret Hospital, Canada
Outcome results
None listed