Clinical trial NCT02540798: Do Patient Anxiety Levels Decrease Urodynamic Test Reproducibility?
Official title: Do Increased Levels of Anxiety Decrease the Reproducibility of Symptoms During Urodynamic Studies in Women?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Overactive Bladder
Urinary Incontinence, Stress
Urinary Incontinence, Urge
Urinary Retention
Keywords: Anxiety
Urodynamics
Symptom reproducibility
Lower urinary tract symptoms
Women
Lead sponsor: Sandwell & West Birmingham Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Sheffield Teaching Hospitals NHS Foundation Trust
First posted: 2015-09-04
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Any patients not covered in the inclusion criteria

Primary outcomes:
measure: Correlate pre-test anxiety scores with the reproducibility of symptom scores from urodynamic studies in women
timeFrame: 9 months
Secondary outcomes:
measure: The number of women who have their typical symptoms reproduced during urodynamic studies
timeFrame: 9 months
measure: Number of women with abnormal (i.e. not normal) urodynamic diagnosis and high pre-test anxiety scores
timeFrame: 9 months
measure: Number of women with abnormal (i.e. not normal) urodynamic diagnosis with low reproducibility of symptom scores
timeFrame: 9 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Sandwell and West Birmingham Hospitals NHS Trust
Study officials:
affiliation: Sandwell and West Birmingham Hospitals NHS Trust
name: Victor Olagundoye
role: PRINCIPAL_INVESTIGATOR
References: