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NCT Number: NCT07451548

RCT on Running Water Sound During Urodynamic

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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Key information

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Caritas Medical Centre, Hong Kong

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Auditory intervention with running water sound

Behavioral

standardized audio via smartphone during pressure flow study

Primary outcomes

  1. 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.

Secondary outcomes

  1. Anxiety level before urodynamic procedure measured by Visual Analogue Scale (VAS)

    Time frame: Immediately before the start of the urodynamic procedure

    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.

  2. 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 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).

  3. 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

    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.

  4. 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

    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.

  5. Proportion of participants able to micturate (void) during pressure-flow study phase

    Time frame: During the pressure-flow study phase of the urodynamic procedure

    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.

  6. 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 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).

  7. 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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Siu Chung Wong, MBBS

CONTACT

[email protected]

+85266916410

Sponsors and collaborators

Lead sponsor

Princess Margaret Hospital, Hong Kong

Other Gov

Collaborators

  • Caritas Medical Centre, Hong Kong

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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