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NCT03317340 Clinical Trial

Environmental Factors to Increase Patient Comfort During Urodynamics Testing

Lower Urinary Tract Symptoms Clinical Trial

Official title:
Environmental Factors to Increase Patient Comfort During Urodynamics Testing

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03317340
Other study ID # 17-003351
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 25, 2017
Est. completion date August 1, 2020

Study information
Verified date December 2020
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Urodynamics is a comprehensive study of the lower urinary tract. Although the information obtained from urodynamics answers several questions and assists in guiding therapies for patients, the testing environments is unnatural and may be distressing for patients. This may impact the results of the study, as it is not uncommon for patients to be unable to void for the test due to their distress. Often to alleviate the distress, music or soothing noises are used in the background. The study aims to identify simple environmental factors which may improve patient experience with urodynamic testing. The population will include patients with existing appointments for urodynamics testing at the Mayo Urology Clinic. The investigators plan to assess patient satisfaction and comfort during this assessment using a visual analog scale questionnaire. The environmental variables will include music of the patients' preference, the sound of running water, or no background noise at all. By asking patients to complete a questionnaire, The investigators will be able to assess ways to improve patient comfort in a commonly used urologic assessment.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date August 1, 2020
Est. primary completion date August 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - All adults undergoing urodynamics - Must be able to understand and complete questionnaire Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Background Sounds
Background music or sound of running water

Locations
Country Name City State
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comfort level with test based off post-urodynamic survey visual analog scale 6 months
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