An interventional study of video in Urinary Incontinence, Urinary Bladder Overactive and Urinary Incontinence , Stress, sponsored by Yair Daykan. Recruiting at 1 site in Israel. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Yair Daykan · Not applicable, Interventional, and Supportive care
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.
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.
651 studies on the registry are indexed under Urinary Incontinence, Stress; 120 are open to participants now.
This study's planned enrollment of 60 is below the median of 68 across 506 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →This is the only study on the registry with Yair Daykan as lead sponsor.
Compared within Urinary Incontinence, Stress, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Urinary Incontinence. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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
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.
A short video explaining the urodynamics test.
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
Time frame: through study completion, an average of 1 hour
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.
Time frame: through study completion, an average of 1 hour
Plan to share: No
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