AnxietyNCT02540798
Do Patient Anxiety Levels Decrease Urodynamic Test Reproducibility?
An observational study of Anxiety and Overactive Bladder, run by Sandwell & West Birmingham Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This study will look at how pre-test anxiety levels affect the reproducibility of symptoms during routine urodynamic testing in women. Urodynamics is a test that assesses the function of the lower urinary tract, including the bladder. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Anxiety, Overactive Bladder, Urinary Incontinence, Stress
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Apr 2016
- 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 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Only patients referred for urodynamics for the first time will be asked to consider being included in the study. Minimum of 30 participants to be included. Recruited via obstetric and urogynaecology clinics.
Who may be able to join
- Women attending for their first time to the urodynamics clinic for the assessment of their bladder function
- Must be over the age of 18 years old
- Must be able to consent for themselves
Who cannot join
- Any patients not covered in the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sandwell and West Birmingham Hospitals NHS Trust
Birmingham, B71 4HJ
About this study
Official title: Do Increased Levels of Anxiety Decrease the Reproducibility of Symptoms During Urodynamic Studies in Women?
This study will look at how pre-test anxiety levels affect the reproducibility of symptoms during routine urodynamic testing in women. Urodynamics is a test that assesses the function of the lower urinary tract, including the bladder.
Read the detailed description
The results of urodynamic tests often determine treatment for patients, which may include bladder retraining, medication and/or surgery. Thus, it is important for the results of urodynamics to be accurate and representative of the patient's symptoms outside of the clinic.
Pre-test anxiety levels in women undergoing urodynamics will be measured using a validated questionnaire HADS (Hospital anxiety and depression scale). The patient, prior to their routine urodynamics test, will fill out this self-administered questionnaire.
Reproducibility of patient symptoms will be measured using a non-validated quantitative bladder test assessment. The patient will fill out this self-administered quantitative bladder assessment after their urodynamics test.
The pre-test anxiety and symptom reproducibility variables will be correlated against each other to assess whether there is correlation between the two. A Spearman Rho test will be used to assess the strength of the relationship.
- Conditions
- Anxiety, Overactive Bladder, Urinary Incontinence, Stress, Urinary Incontinence, Urge, Urinary Retention
- Keywords
- Anxiety, Urodynamics, Symptom reproducibility, Lower urinary tract symptoms, Women
- Medical subject headings
- Anxiety Disorders, Urinary Bladder, Overactive, Urinary Incontinence, Stress, Urinary Incontinence, Urge, Urinary Retention, Lower Urinary Tract Symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlate pre-test anxiety scores with the reproducibility of symptom scores from urodynamic studies in women
Measured: 9 months
Secondary outcomes (3)
The number of women who have their typical symptoms reproduced during urodynamic studies
Measured: 9 months
Number of women with abnormal (i.e. not normal) urodynamic diagnosis and high pre-test anxiety scores
Measured: 9 months
Number of women with abnormal (i.e. not normal) urodynamic diagnosis with low reproducibility of symptom scores
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust
- Responsible party
- Principal investigator, Stephanie Smith, Sandwell & West Birmingham Hospitals NHS Trust
- Investigators
- Victor Olagundoye, Principal investigator, Sandwell and West Birmingham Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540798
- Sponsor's protocol ID
- SandwellWBNHS
- Status last verified
- Oct 2016
- First submitted
- 7 Aug 2015
- Last updated
- 24 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Increased Levels of Anxiety Decrease the Reproducibility of Symptoms During Urodynamic Studies in Women?
- ClinicalTrials.gov ID
- NCT02540798
- Acronym / sponsor ID
- SandwellWBNHS
- Conditions
- Anxiety, Overactive Bladder, Urinary Incontinence, Stress, Urinary Incontinence, Urge, Urinary Retention
- Keywords
- Anxiety, Urodynamics, Symptom reproducibility, Lower urinary tract symptoms, Women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust
- Study start
- Jul 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 4 Sep 2015 (estimated)
- 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.
This study will look at how pre-test anxiety levels affect the reproducibility of symptoms during routine urodynamic testing in women. Urodynamics is a test that assesses the function of the lower urinary tract, including the bladder.
Detailed description
The results of urodynamic tests often determine treatment for patients, which may include bladder retraining, medication and/or surgery. Thus, it is important for the results of urodynamics to be accurate and representative of the patient's symptoms outside of the clinic.
Pre-test anxiety levels in women undergoing urodynamics will be measured using a validated questionnaire HADS (Hospital anxiety and depression scale). The patient, prior to their routine urodynamics test, will fill out this self-administered questionnaire.
Reproducibility of patient symptoms will be measured using a non-validated quantitative bladder test assessment. The patient will fill out this self-administered quantitative bladder assessment after their urodynamics test.
The pre-test anxiety and symptom reproducibility variables will be correlated against each other to assess whether there is correlation between the two. A Spearman Rho test will be used to assess the strength of the relationship.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Only patients referred for urodynamics for the first time will be asked to consider being included in the study. Minimum of 30 participants to be included. Recruited via obstetric and urogynaecology clinics.
Key inclusion criteria (3 listed)
- Women attending for their first time to the urodynamics clinic for the assessment of their bladder function
- Must be over the age of 18 years old
- Must be able to consent for themselves
Key exclusion criteria (1 listed)
- Any patients not covered in the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlate pre-test anxiety scores with the reproducibility of symptom scores from urodynamic studies in women
Time frame: 9 months
3 secondary outcomes
The number of women who have their typical symptoms reproduced during urodynamic studies
Time frame: 9 months
Number of women with abnormal (i.e. not normal) urodynamic diagnosis and high pre-test anxiety scores
Time frame: 9 months
Number of women with abnormal (i.e. not normal) urodynamic diagnosis with low reproducibility of symptom scores
Time frame: 9 months
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 24 Oct 2016.
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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.
Victor Olagundoye principal investigator
Sandwell and West Birmingham Hospitals NHS Trust
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 Anxiety and Overactive Bladder, run by Sandwell & West Birmingham Hospitals NHS Trust at 1 site in United Kingdom.
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 3 inclusion and 1 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 24 Oct 2016. 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 Kingdom. 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?
Correlate pre-test anxiety scores with the reproducibility of symptom scores from urodynamic studies in women (time frame: 9 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 24 Oct 2016.