NCT07451548

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Dec 2025Nov 2027

Study Start

First participant enrolled

December 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

March 5, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

February 13, 2026

Last Update Submit

February 28, 2026

Conditions

Keywords

UrodynamicsAnxietyRunning water soundMaximum flow rate

Outcome Measures

Primary Outcomes (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.

    During the pressure-flow study phase of the urodynamic procedure

Secondary Outcomes (7)

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

    Immediately before the start of the urodynamic procedure

  • Anxiety level during pressure-flow study measured by Visual Analogue Scale (VAS)

    During the pressure-flow study phase of the urodynamic procedure

  • Anxiety level within 15 minutes after urodynamic procedure measured by Visual Analogue Scale (VAS)

    Within 15 minutes after completion of the urodynamic procedure

  • Detrusor pressure at maximum flow rate (PdetQmax) measured by urodynamic pressure-flow study

    During the pressure-flow study phase of the urodynamic procedure

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

    During the pressure-flow study phase of the urodynamic procedure

  • +2 more secondary outcomes

Study Arms (2)

Water sound

EXPERIMENTAL

Standard urodynamics + running water sound

Behavioral: Auditory intervention with running water sound

Control

NO INTERVENTION

Standard urodynamics

Interventions

standardized audio via smartphone during pressure flow study

Water sound

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Caritas Medical Centre

Hong Kong, 00000, Hong Kong

RECRUITING

Princess Margaret Hospital

Hong Kong, 00000, Hong Kong

RECRUITING

Related Publications (4)

  • 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.

    PMID: 25733264BACKGROUND
  • 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.

    PMID: 28834330BACKGROUND
  • 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.

    PMID: 25978378BACKGROUND
  • 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.

    PMID: 37798889BACKGROUND

MeSH Terms

Conditions

Lower Urinary Tract SymptomsAnxiety Disorders

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Siu Chung Wong

    Princess Margaret Hospital, Canada

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Siu Chung Wong, MBBS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 13, 2026

First Posted

March 5, 2026

Study Start

December 1, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2027

Last Updated

March 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF
Time Frame
1/12/2027, 30/11/2030

Locations