Environmental Factors to Increase Patient Comfort During Urodynamics Testing

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT03317340

Collaborator

(none)

200

Enrollment

Location

35.2

Actual Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lower Urinary Tract Symptoms Urologic Diseases	Other: Background Sounds

Study Design

Study Type:

Observational

Actual Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Environmental Factors to Increase Patient Comfort During Urodynamics Testing

Actual Study Start Date :

Aug 25, 2017

Actual Primary Completion Date :

Aug 1, 2020

Actual Study Completion Date :

Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Patient Undergoing Urodynamics	Other: Background Sounds Background music or sound of running water

Arm

Intervention/Treatment

Patient Undergoing Urodynamics

Other: Background Sounds

Background music or sound of running water

Outcome Measures

Primary Outcome Measures

Comfort level with test based off post-urodynamic survey [6 months]
visual analog scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

All adults undergoing urodynamics
Must be able to understand and complete questionnaire

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Aqsa A Khan, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Aqsa A. Khan, Principle Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT03317340

Other Study ID Numbers:

17-003351

First Posted:

Oct 23, 2017

Last Update Posted:

Dec 8, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urologic Diseases

Lower Urinary Tract Symptoms

Study Results

No Results Posted as of Dec 8, 2020