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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
Hong Kong2 sites, 2 recruiting
- 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
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.
- Conditions
- Lower Urinary Tract Symptoms (LUTS)
- 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 group | Role | What they receive |
|---|---|---|
| Water sound | Experimental | Standard urodynamics + running water sound Receives: Behavioral: Auditory intervention with running water sound |
| Control | No intervention | Standard urodynamics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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.
- First posted5 Mar 2026
- Study start1 Dec 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract Symptoms (LUTS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Princess Margaret Hospital, Hong Kong
- Sponsor type
- Other government
- Collaborators
- Caritas Medical Centre, Hong Kong
- Responsible party
- Principal investigator, Wong Siu Chung, Princess Margaret Hospital, Hong Kong
- Investigators
- Siu Chung Wong, Principal investigator, Princess Margaret Hospital, Canada
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 25733264Ozturk 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 28834330Kwon 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 25978378Culha 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Running Water Sound on Anxiety and Urodynamic Parameters: A Multi-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07451548
- Acronym / sponsor ID
- water sound in urodynamic
- Conditions
- Lower Urinary Tract Symptoms (LUTS)
- Keywords
- Urodynamics, Anxiety, Running water sound, Maximum flow rate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Princess Margaret Hospital, Hong KongOther government
- Collaborators
- Caritas Medical Centre, Hong Kong
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water sound | Experimental | Behavioral: Auditory intervention with running water soundStandard urodynamics + running water sound |
| Control | No intervention | –Standard urodynamics |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chinese women aged 18-90 years scheduled for urodynamic study.
- Understand written traditional Chinese.
- Willing to participate and provide a written informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory intervention with running water soundstandardized audio via smartphone during pressure flow study | Behavioural | Water sound |
Primary outcome
Maximum urinary flow rate (Qmax) measured by urodynamic pressure-flow study
Time frame: 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.
7 secondary outcomes
Anxiety level before urodynamic procedure measured by Visual Analogue Scale (VAS)
Time frame: Immediately before the start of the urodynamic procedure
Anxiety level during pressure-flow study measured by Visual Analogue Scale (VAS)
Time frame: During the pressure-flow study phase of the urodynamic procedure
Anxiety level within 15 minutes after urodynamic procedure measured by Visual Analogue Scale (VAS)
Time frame: Within 15 minutes after completion of the urodynamic procedure
Detrusor pressure at maximum flow rate (PdetQmax) measured by urodynamic pressure-flow study
Time frame: During the pressure-flow study phase of the urodynamic procedure
Proportion of participants able to micturate (void) during pressure-flow study phase
Time frame: During the pressure-flow study phase of the urodynamic procedure
Bladder Outlet Obstruction Index (BOOI) calculated from urodynamic pressure-flow study
Time frame: At the point of maximum urinary flow rate during the pressure-flow study
Bladder Contractility Index (BCI) calculated from urodynamic pressure-flow study
Time frame: At the point of maximum urinary flow rate during the pressure-flow study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Background: PubMed 25733264Suskind 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.
- Background: PubMed 28834330Ozturk 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.
- Background: PubMed 25978378Kwon 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.
- Background: PubMed 37798889Culha 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Siu Chung Wong principal investigator
Princess Margaret Hospital, Canada
2 sites in 1 country: see every site and its status.
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.