Urinary IncontinenceVIDEO-UNCT07740629
Does Use of a Pre-Procedure Educational Video for Urodynamic Testing Reduces Anxiety?
A study testing video in people with Urinary Incontinence and Urinary Bladder Overactive, run by Yair Daykan at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Urinary Bladder Overactive, Urinary Incontinence , Stress
- What is being tested?
- video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2026to 1 May 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women 18 years and above, undergoing a urodynamics test
Who cannot join
- women under SSRI/SNRI treatment women with a known anxiety disorder women who had a previous urodynamics test
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba, Israel, 11125
Yair M Daykan, MD, 972-54-2198231, yair.dykan@gmail.com
About this study
Official title: Use of a Pre-Procedure Educational Video for Urodynamic Testing as a Tool to Reduce Anxiety: A Prospective Randomized Study
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.
Read the detailed description
his study examines whether viewing a short educational video before urodynamic testing reduces anxiety, embarrassment, and discomfort, and improves participants' understanding of the procedure. Urodynamic testing evaluates bladder and urethral sphincter function, and many women experience stress before undergoing the examination. Eligible participants are women whose treating physician has recommended urodynamic testing as part of the evaluation of urinary or pelvic floor symptoms. Participation in the study is entirely voluntary.
Following informed consent, participants will meet with a member of the research team, who will explain the purpose of the study and the urodynamic procedure. Participants will then be randomly assigned to either an educational video intervention group or a standard verbal explanation group. Before the procedure, participants will complete brief questionnaires assessing stress level, coping style, and demographic and clinical characteristics. A saliva sample will be collected for cortisol measurement as an objective biomarker of stress, and blood pressure and heart rate will be recorded.
During urodynamic testing, participants will rate anxiety and pain using a numerical rating scale from 1 to 10, and an additional saliva sample will be collected. After completion of the examination, participants will complete a brief questionnaire evaluating the overall experience, including anxiety, embarrassment, and discomfort. The total duration of study-related procedures, including urodynamic testing, is approximately one hour.
No additional medical risks are anticipated beyond those associated with standard urodynamic testing. Some participants may experience minor discomfort when answering personal questions or providing saliva samples. No additional procedural risks are expected. Although individual benefit cannot be guaranteed, participation may improve preparation for urodynamic testing and reduce anxiety or discomfort. The knowledge gained from this study may contribute to improving the care of future patients undergoing urodynamic evaluation.
All study data will be coded and maintained confidentially to protect participant privacy. Access to identifiable information will be limited to the investigators and authorized regulatory authorities, in accordance with applicable regulations. No identifying information will appear in reports or publications. Participation is voluntary, and participants may decline participation or withdraw from the study at any time without affecting current or future medical care.
- Being tested
- video
- Keywords
- Urinary Incontinence, Urodymanics, Video, Stress, Cortisol
- Medical subject headings
- Urinary Incontinence, Urinary Bladder, Overactive, Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
videoOther
A short video explaining the urodynamics test.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 hour
Secondary outcomes (1)
Heart rate and subjective questionnaires
Comparison between levels of heart rate and subjective anxiety level questionnaire scores, before and during the urodynamics test, between the two groups.
Measured: through study completion, an average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Aug 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yair Daykan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yair Daykan, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740629
- Sponsor's protocol ID
- 0210-20-MMC
- Acronym
- VIDEO-U
- Status last verified
- Aug 2026
- First submitted
- 15 Dec 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Pre-Procedure Educational Video for Urodynamic Testing as a Tool to Reduce Anxiety: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07740629
- Acronym / sponsor ID
- VIDEO-U / 0210-20-MMC
- Keywords
- Urinary Incontinence, Urodymanics, Video, Stress, Cortisol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yair DaykanUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 31 Jul 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.
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.
Detailed description
his study examines whether viewing a short educational video before urodynamic testing reduces anxiety, embarrassment, and discomfort, and improves participants' understanding of the procedure. Urodynamic testing evaluates bladder and urethral sphincter function, and many women experience stress before undergoing the examination. Eligible participants are women whose treating physician has recommended urodynamic testing as part of the evaluation of urinary or pelvic floor symptoms. Participation in the study is entirely voluntary.
Following informed consent, participants will meet with a member of the research team, who will explain the purpose of the study and the urodynamic procedure. Participants will then be randomly assigned to either an educational video intervention group or a standard verbal explanation group. Before the procedure, participants will complete brief questionnaires assessing stress level, coping style, and demographic and clinical characteristics. A saliva sample will be collected for cortisol measurement as an objective biomarker of stress, and blood pressure and heart rate will be recorded.
During urodynamic testing, participants will rate anxiety and pain using a numerical rating scale from 1 to 10, and an additional saliva sample will be collected. After completion of the examination, participants will complete a brief questionnaire evaluating the overall experience, including anxiety, embarrassment, and discomfort. The total duration of study-related procedures, including urodynamic testing, is approximately one hour.
No additional medical risks are anticipated beyond those associated with standard urodynamic testing. Some participants may experience minor discomfort when answering personal questions or providing saliva samples. No additional procedural risks are expected. Although individual benefit cannot be guaranteed, participation may improve preparation for urodynamic testing and reduce anxiety or discomfort. The knowledge gained from this study may contribute to improving the care of future patients undergoing urodynamic evaluation.
All study data will be coded and maintained confidentially to protect participant privacy. Access to identifiable information will be limited to the investigators and authorized regulatory authorities, in accordance with applicable regulations. No identifying information will appear in reports or publications. Participation is voluntary, and participants may decline participation or withdraw from the study at any time without affecting current or future medical care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group- video | Experimental | Other: videoParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women 18 years and above, undergoing a urodynamics test
Key exclusion criteria (1 listed)
- women under SSRI/SNRI treatment women with a known anxiety disorder women who had a previous urodynamics test
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 |
|---|---|---|
| videoA short video explaining the urodynamics test. | Other | Study group- video |
Primary outcome
Anxiety represented by cortisol levels
Time frame: through study completion, an average of 1 hour
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
1 secondary outcome
Heart rate and subjective questionnaires
Time frame: through study completion, an average of 1 hour
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 4 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video in people with Urinary Incontinence and Urinary Bladder Overactive, run by Yair Daykan at 1 site in Israel.
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 1 inclusion and 1 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 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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 yair daykan, Dr (+972542198231, yair.dykan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety represented by cortisol levels (time frame: through study completion, an average of 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.