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| Name | Class |
|---|---|
| Caritas Medical Centre, Hong Kong | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Water sound | Experimental | Standard urodynamics + running water sound |
|
| Control | No Intervention | Standard urodynamics |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auditory intervention with running water sound | Behavioral | standardized audio via smartphone during pressure flow study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum urinary flow rate (Qmax) measured by urodynamic pressure-flow study | 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. | During the pressure-flow study phase of the urodynamic procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety level before urodynamic procedure measured by Visual Analogue Scale (VAS) | 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. | Immediately before the start of the urodynamic procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Siu Chung Wong, MBBS | Contact | +85266916410 | jackiejpwsc@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Siu Chung Wong | Princess Margaret Hospital, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Caritas Medical Centre | Recruiting | Hong Kong | 00000 | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25733264 | Background | Suskind AM, Clemens JQ, Kaufman SR, Stoffel JT, Oldendorf A, Malaeb BS, Jandron T, Cameron AP. Patient perceptions of physical and emotional discomfort related to urodynamic testing: a questionnaire-based study in men and women with and without neurologic conditions. Urology. 2015 Mar;85(3):547-51. doi: 10.1016/j.urology.2014.11.001. | |
| 28834330 |
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1/12/2027, 30/11/2030
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 6, 2026 | Feb 13, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 12, 2025 | Feb 28, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| Anxiety level during pressure-flow study measured by Visual Analogue Scale (VAS) | 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). | During the pressure-flow study phase of the urodynamic procedure |
| Anxiety level within 15 minutes after urodynamic procedure measured by Visual Analogue Scale (VAS) | 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. | Within 15 minutes after completion of the urodynamic procedure |
| Detrusor pressure at maximum flow rate (PdetQmax) measured by urodynamic pressure-flow study | 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. | During the pressure-flow study phase of the urodynamic procedure |
| Proportion of participants able to micturate (void) during pressure-flow study phase | 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. | During the pressure-flow study phase of the urodynamic procedure |
| Bladder Outlet Obstruction Index (BOOI) calculated from urodynamic 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). | At the point of maximum urinary flow rate during the pressure-flow study |
| Bladder Contractility Index (BCI) calculated from urodynamic 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). | At the point of maximum urinary flow rate during the pressure-flow study |
| Princess Margaret Hospital | Recruiting | Hong Kong | 00000 | Hong Kong |
|
| Ozturk E, Hamidi N, Yikilmaz TN, Ozcan C, Basar H. Effect of Listening to Music on Patient Anxiety and Pain Perception during Urodynamic Study: Randomized Controlled Trial. Low Urin Tract Symptoms. 2019 Jan;11(1):39-42. doi: 10.1111/luts.12191. Epub 2017 Aug 23. |
| 25978378 | Background | Kwon WA, Kim SH, Kim S, Joung JY, Chung J, Lee KH, Lee SJ, Seo HK. Changes in urination according to the sound of running water using a mobile phone application. PLoS One. 2015 May 15;10(5):e0126798. doi: 10.1371/journal.pone.0126798. eCollection 2015. |
| 37798889 | Background | Culha Y, Ak ES, Culha MG. The Effect of Running Water Sound Listened to Patients During Urodynamics on Anxiety and Urodynamic Parameters. Int Neurourol J. 2023 Sep;27(3):217-223. doi: 10.5213/inj.2346116.058. Epub 2023 Sep 30. |