NCT03317340

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 23, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

December 8, 2020

Status Verified

December 1, 2020

Enrollment Period

2.9 years

First QC Date

October 3, 2017

Last Update Submit

December 4, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comfort level with test based off post-urodynamic survey

    visual analog scale

    6 months

Study Arms (1)

Patient Undergoing Urodynamics

Other: Background Sounds

Interventions

Background music or sound of running water

Patient Undergoing Urodynamics

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing urodynamics

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

MeSH Terms

Conditions

Lower Urinary Tract SymptomsUrologic Diseases

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Aqsa A Khan

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

October 3, 2017

First Posted

October 23, 2017

Study Start

August 25, 2017

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

December 8, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations