RCT on Running Water Sound During Urodynamic

Impact of Running Water Sound on Anxiety and Urodynamic Parameters: A Multi-Center Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Lower Urinary Tract Symptoms (LUTS)
• Intervention / Treatment: Behavioral: Auditory intervention with running water sound

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Siu Chung Wong, MBBS; Phone Number: +85266916410; Email: jackiejpwsc@gmail.com

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 00000
    • Recruiting
    • Caritas Medical Centre
    • Contact: Siu Chung Wong, MBBS; Phone Number: +85266916410; Email: jackiejpwsc@gmail.com
  • Hong Kong, Hong Kong, 00000
    • Recruiting
    • Princess Margaret Hospital
    • Contact: Siu Chung Wong, MBBS; Phone Number: +85266916410; Email: jackiejpwsc@gmail.com
    • Principal Investigator: Siu Chung Wong, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Water sound; Standard urodynamics + running water sound	Behavioral: Auditory intervention with running water sound; standardized audio via smartphone during pressure flow study
No Intervention: Control; Standard urodynamics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Princess Margaret Hospital, Hong Kong
• Collaborators: Caritas Medical Centre, Hong Kong
• Investigators: Principal Investigator: Siu Chung Wong, Princess Margaret Hospital, Canada

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: February 13, 2026
• First Submitted That Met QC Criteria: February 28, 2026
• First Posted (Actual): March 5, 2026

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: February 28, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Anxiety; Urodynamics; Running water sound; Maximum flow rate
• Additional Relevant MeSH Terms: Mental Disorders; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Anxiety Disorders; Lower Urinary Tract Symptoms
• Other Study ID Numbers: water sound in urodynamic

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 1/12/2027, 30/11/2030
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No