Lower Urinary Tract SymptomsNCT03317340
Environmental Factors to Increase Patient Comfort During Urodynamics Testing
An observational study of Lower Urinary Tract Symptoms and Urologic Diseases, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Urinary Tract Symptoms, Urologic Diseases
- What is being tested?
- Background Sounds
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2017to 1 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing urodynamics
Who may be able to join
- All adults undergoing urodynamics
- Must be able to understand and complete questionnaire
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lower Urinary Tract Symptoms, Urologic Diseases
- Being tested
- Background Sounds
- Medical subject headings
- Lower Urinary Tract Symptoms, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Background SoundsOther
Background music or sound of running water
| Study group | Role | What they receive |
|---|---|---|
| Patient Undergoing Urodynamics | Not described Receives: Other: Background Sounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort level with test based off post-urodynamic survey
visual analog scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start25 Aug 2017
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aqsa A. Khan, Mayo Clinic
- Investigators
- Aqsa A Khan, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317340
- Sponsor's protocol ID
- 17-003351
- Status last verified
- Dec 2020
- First submitted
- 3 Oct 2017
- Last updated
- 8 Dec 2020
- 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 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Factors to Increase Patient Comfort During Urodynamics Testing
- ClinicalTrials.gov ID
- NCT03317340
- Acronym / sponsor ID
- 17-003351
- Conditions
- Lower Urinary Tract Symptoms, Urologic Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 23 Oct 2017 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Undergoing Urodynamics | – | Other: Background Sounds |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing urodynamics
Key inclusion criteria (2 listed)
- All adults undergoing urodynamics
- Must be able to understand and complete questionnaire
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Background SoundsBackground music or sound of running water | Other | Patient Undergoing Urodynamics |
Primary outcome
Comfort level with test based off post-urodynamic survey
Time frame: 6 months
visual analog scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Aqsa A Khan principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms and Urologic Diseases, run by Mayo Clinic at 1 site in United States.
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 2 inclusion and 0 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: finished, as of the sponsor's last update on 8 Dec 2020. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comfort level with test based off post-urodynamic survey (time frame: 6 months). 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 8 Dec 2020.