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Lower Urinary Tract Symptoms (LUTS)NCT07451548

RCT on Running Water Sound During Urodynamic

A study testing Auditory intervention with running water sound in people with Lower Urinary Tract Symptoms (LUTS), run by Princess Margaret Hospital, Hong Kong at 2 sites in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years, women only
Conditions the study is for
Lower Urinary Tract Symptoms (LUTS)
What is being tested?
Auditory intervention with running water sound
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
2 sitesHong Kong
Study dates
1 Dec 2025to 30 Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chinese women aged 18-90 years scheduled for urodynamic study.
  • Understand written traditional Chinese.
  • Willing to participate and provide a written informed consent.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Siu Chung Wong, MBBS contact

+85266916410

jackiejpwsc@gmail.com

Hong Kong2 sites, 2 recruiting
  • Caritas Medical Centre

    Hong Kong, 00000

    Siu Chung Wong, MBBS, +85266916410, jackiejpwsc@gmail.com

    Recruiting
  • Princess Margaret Hospital

    Hong Kong, 00000

    Siu Chung Wong, MBBS, +85266916410, jackiejpwsc@gmail.com

    Siu Chung Wong, MBBS

    Recruiting

Other trials in Hong Kong

About this study

Official title: 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.

Being tested
Auditory intervention with running water sound
Keywords
Urodynamics, Anxiety, Running water sound, Maximum flow rate
Medical subject headings
Lower Urinary Tract Symptoms, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Auditory intervention with running water soundBehavioural

    standardized audio via smartphone during pressure flow study

Study groups in NCT07451548
Study groupRoleWhat they receive
Water soundExperimentalStandard urodynamics + running water sound
Receives: Behavioral: Auditory intervention with running water sound
ControlNo interventionStandard urodynamics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: During the pressure-flow study phase of the urodynamic procedure

Secondary outcomes (7)
  1. 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.

    Measured: Immediately before the start of the urodynamic procedure

  2. 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).

    Measured: During the pressure-flow study phase of the urodynamic procedure

  3. 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.

    Measured: Within 15 minutes after completion of the urodynamic procedure

  4. 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.

    Measured: During the pressure-flow study phase of the urodynamic procedure

  5. 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.

    Measured: During the pressure-flow study phase of the urodynamic procedure

  6. 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).

    Measured: At the point of maximum urinary flow rate during the pressure-flow study

  7. 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).

    Measured: At the point of maximum urinary flow rate during the pressure-flow study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2026
  2. Study start1 Dec 2025
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07451548
Sponsor's protocol ID
water sound in urodynamic
Status last verified
Feb 2026
First submitted
13 Feb 2026
Last updated
5 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 25733264
  • 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.

    PubMed 28834330
  • 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.

    PubMed 25978378
  • 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.

    PubMed 37798889

Questions about this trial

What is this clinical trial studying?

A study testing Auditory intervention with running water sound in people with Lower Urinary Tract Symptoms (LUTS), run by Princess Margaret Hospital, Hong Kong at 2 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Siu Chung Wong, MBBS (+85266916410, jackiejpwsc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum urinary flow rate (Qmax) measured by urodynamic pressure-flow study (time frame: During the pressure-flow study phase of the urodynamic procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07451548, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.

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