Impact of Running Water Sound on Anxiety and Urodynamic Parameters: A Multi-Center Randomized Controlled Trial
Phase: NA
Conditions: Lower Urinary Tract Symptoms (LUTS)
Sponsor: Princess Margaret Hospital, Hong Kong

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Impact of Running Water Sound on Anxiety and Urodynamic 
Parameters: A Multi-Center Randomized Controlled Trial 
 
Principal investigator: Dr Wong Siu Chung, Associate Consultant, Department of 
Obstetrics and Gynaecology, Princess Margaret Hospital  
Address: Department of Obstetrics and Gynaecology, Princess Margaret Hospital  
Contact: 66916410  
 
Introduction  
Urodynamic study is a critical diagnostic tool for assessing lower urinary tract 
dysfunction but is often associated with patient discomfort and anxiety due to its 
invasive nature [1]. Anxiety during urodynamics can hinder micturition, affecting the 
reliability of pressure-flow study results [2]. Previous studies have suggested that 
auditory interventions, such as the sound of running water, may reduce anxiety and 
enhance detrusor muscle activity, thereby improving urodynamic parameters [3]. This 
study seeks to validate the findings of Culha et al. (2023), which demonstrated that 
listening to running water during urodynamics significantly reduced anxiety and 
improved micturition parameters [4]. The primary aim is to determine whether this 
intervention can be effectively implemented in our centers to enhance patient 
experience and diagnostic accuracy using a robust randomized controlled trial design.  
 
Objectives  
The primary objective is to assess the effect of running water sound during urodynamic 
study on maximum flow rate (Qmax). The secondary objectives are to evaluate the 
effect of running water sound on patients’ anxiety levels, as measured by the Visual 
Analogue Scale (VAS), other urodynamic parameters and to compare the proportion of 
patients able to micturate during the pressure-flow study between the experimental and 
control groups. 
 
Material and methods  
This is a multi-center randomized controlled trial conducted at Princess Margaret 
Hospital and Caritas Medical Centre involving 240 patients undergoing urodynamic 

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study. CMS system will be used for screening eligible subjects. Eligible patients will 
be approached during their scheduled urodynamic appointment, provided with the 
consent form and questionnaire. Written informed consent is obtained from all 
participants before study group allocation. Patients will be randomly assigned to either 
experimental group or control group. The experimental group will listen to a 
standardized recording of running water in relaxed melody played via a smartphone 
during the pressure-flow study phase of urodynamics. The control group will undergo 
standard urodynamic testing without any auditory intervention. Urodynamic study will 
be performed by trained gynaecologists. The urodynamic procedure will be consistent 
across both groups and centers, involving uroflowmetry, cystometry, and pressure-flow 
study, with catheters placed as per standard protocol. 
 
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.  
 
Randomization  
Participants are recruited and assigned randomly in 1:1 ratio to control group or 
experimental group. Randomization will be performed using a computer-generated 
random number sequence with a 1:1 allocation ratio. A block randomization method 
with random blocks of two, four and six will be used to maintain allocation concealment. 
The randomization sequence will be generated by an independent statistician and stored 
in sealed, opaque, sequentially numbered envelopes. Upon enrollment, a nurse will 
open the next envelope to assign the patient to either the control or experimental group. 

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This process ensures blinding of the allocation sequence to the research team until 
assignment.  
 
Data Collection  
All participants will provide written informed consent using a standardized consent 
form approved by the ethics committee. The form will detail the study purpose, 
procedures, potential risks, benefits and the right to withdraw at any time without 
affecting their care. A structured questionnaire will collect sociodemographic data, 
medical history and urinary symptoms. The questionnaire will be distributed to 
participants by a trained nurse before the urodynamic procedure. Anxiety will be 
measured using VAS before, during, and after the urodynamic procedure. Urodynamic 
Parameters will be measured as standard protocol during urodynamic study.  
 
Outcome measures 
Primary outcome: Maximum flow rate (Qmax). 
Secondary outcome: Difference in mean anxiety levels as measured by VAS between 
experimental and control groups, proportion of patients able to micturate during 
pressure-flow study, detrusor pressure at maximum flow rate (PdetQmax), bladder 
outlet obstruction index (BOOI) and bladder contractility index (BCI).  
 
Sample Size Calculation 
The sample size is calculated based on the maximum flow rate (Qmax) of the 
experimental and control groups, as reported by Culha et al. (2023) [4]. In their study, 
the maximum flow rate was 5.20 ± 7.13 ml/s in the control group and 8.27 ± 7.76 ml/s 
in the intervention group, yielding a mean difference of 3.07 ml/s and an approximate 
pooled standard deviation of 7.45 ml/s (calculated as √((7.13^2 + 7.76^2)/2). The 
required sample size for comparing two independent means was calculated using a two-
sided two-sample t test with a significance level of 0.05 and power of 80%. Using a 
mean difference of 3.07 ml/s and a common standard deviation of 7.45 ml/s, the formula 
gives approximately 93 participants per group. Assuming a 20% dropout or non-
evaluable rate, the adjusted sample size is approximately 116 participants per group. To 
ensure adequate power to detect the expected difference in Qmax between groups and 
account for the multi-center design, we therefore plan to recruit 120 participants per 
group.  

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Statistical Analysis 
Data will be analyzed using IBM SPSS Statistics (version 27.0.1). Descriptive statistics 
(mean, standard deviation, frequency) will summarize patient characteristics and 
outcomes. Comparisons between groups will use Student’s t-test for normally 
distributed continuous variables, Mann-Whitney U-test for non-normally distributed 
variables, Chi-square or Fisher’s exact test for categorical variables. An intention-to-
treat analysis will be performed to account for dropouts. Statistical significance will be 
set at p<0.05. 
 
Data Management and Protection 
All patient data will be handled in compliance with the Personal Data (Privacy) 
Ordinance of Hong Kong and the Declaration of Helsinki. Data will be collected via 
paper-based consent forms and questionnaires, and electronic urodynamic 
measurements. Each participant will be assigned a unique study ID to anonymize data. 
Paper forms will be stored in a locked cabinet in a secure oﬀice accessible only to the 
research team. Electronic data will be stored on a password-protected, encrypted server 
hosted by Princess Margaret Hospital, with access restricted to authorized personnel. 
All identifiable information will be removed, and only study IDs will be used in analysis 
and reporting. Only IRB/REC, principal investigator and designated research team 
members will have access to the data. Data will be retained for 5 years post-study 
completion, as per institutional guidelines, after which paper records will be securely 
shredded, and electronic data will be deleted.  
 
Ethical Considerations 
The study will be conducted in accordance with the Declaration of Helsinki and the 
ICH guideline for good clinical practice. Ethical approval will be sought from the Ethics 
Committees of Princess Margaret Hospital and Caritas Medical Centre. Any 
participation in the research study is completely voluntary. Any person is free to decline 
to participate for any reason. Study details will be provided and written informed 
consent will be obtained. Participants will receive a copy of the consent form. Data 
confidentiality will be maintained as described in the Data Management section. No 
financial incentives will be offered, but participants will not incur additional costs. 

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Conflict of Interest 
The principal investigator and the research team declare no conflict of interest related 
to this study. No funding or sponsorship has been received from entities that could 
influence the study outcomes.  
 
Timetable 
Proposed study period: 1/12/2025 to 30/11/2027 
 
Direct Access to Source Data/Documents 
The investigator(s)/institution(s) will permit trial-related monitoring, audits, IRB/REC 
review, and regulatory inspection(s), providing direct access to source data/documents. 
 
Publication Policy 
N/A 
 
References 
1. Öztürk E, Hamidi N, Yikilmaz TN, Özcan C, Başar H. Effect of Listening to 
Music on Patient Anxiety and Pain Perception during Urodynamic Study: 
Randomized Controlled Trial. Low Urin Tract Symptoms. 2019;11(1):39-42.  
2. Suskind AM, Clemens JQ, Kaufman SR, et al. 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;85(3):547-551.  
3. Kwon WA, Kim SH, Kim S, et al. Changes in urination according to the sound 
of 
running 
water 
using 
a 
mobile 
phone 
application. PLoS 
One. 
2015;10(5):e0126798. Published 2015 May 15. 
4. Çulha Y, Ak ES, Çulha MG. The Effect of Running Water Sound Listened to 
Patients During Urodynamics on Anxiety and Urodynamic Parameters. Int 
Neurourol J. 2023;27(3):217-223.