NCT07740629

Brief Summary

The objective of this randomized prospective study is to evaluate whether viewing an educational video before urodynamic testing reduces anxiety among women undergoing evaluation for pelvic floor or urinary symptoms. The primary research question is: Does viewing a short educational video before urodynamic testing reduce objective and subjective anxiety levels and improve the overall testing experience? Participants scheduled to undergo urodynamic testing as part of routine clinical care will be randomly assigned to either an educational video intervention or standard pre-procedure counseling alone. Participants will complete brief questionnaires, provide saliva samples for cortisol measurement as an objective biomarker of stress, and report anxiety and pain levels before, during, and after urodynamic testing.

Trial Health

63
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Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2025

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

July 31, 2026

Status Verified

July 1, 2026

Enrollment Period

9 months

First QC Date

December 15, 2025

Last Update Submit

July 28, 2026

Conditions

Keywords

Urinary Incontinence, UrodymanicsVideoStressCortisol

Outcome Measures

Primary Outcomes (1)

  • Anxiety represented by cortisol levels

    Comparison between levels of salivary cortisol concentrations before and at the end of the urodynamics test, between the two groups. Cortisol level in nmol/L . the higher difference show increase in stress level

    through study completion, an average of 1 hour

Secondary Outcomes (1)

  • Heart rate and subjective questionnaires

    through study completion, an average of 1 hour

Study Arms (2)

Study group- video

EXPERIMENTAL

Participants in the intervention arm will watch a short educational video explaining the purpose, steps, and sensations expected during urodynamic testing. They will then undergo the standard urodynamic procedure. Anxiety will be assessed using questionnaires and saliva cortisol samples before, during, and after the test, along with self-reported pain and discomfort levels.Video before urodynamics; anxiety measured by surveys and cortisol.

Other: video

Control group- No video

NO INTERVENTION

Participants in the control arm will receive the standard verbal explanation routinely provided before urodynamic testing, without viewing the educational video. They will then undergo the same assessments as the intervention group, including questionnaires, saliva cortisol collection, and self-reported measures of anxiety, pain, and discomfort at the same time points.

Interventions

videoOTHER

A short video explaining the urodynamics test.

Study group- video

Eligibility Criteria

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

You may qualify if:

  • women 18 years and above, undergoing a urodynamics test

You may not qualify if:

  • women under SSRI/SNRI treatment women with a known anxiety disorder women who had a previous urodynamics test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel, 11125, Israel

Location

MeSH Terms

Conditions

Urinary IncontinenceUrinary Bladder, OveractiveUrinary Incontinence, Stress

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary Bladder Diseases

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Central Study Contacts

yair daykan, Dr

CONTACT

Study Design

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

Study Record Dates

First Submitted

December 15, 2025

First Posted

July 31, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

July 31, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations