Do Patient Anxiety Levels Decrease Urodynamic Test Reproducibility?

Sponsor

Sandwell & West Birmingham Hospitals NHS Trust (Other)

Overall Status

Completed

CT.gov ID

NCT02540798

Collaborator

Sheffield Teaching Hospitals NHS Foundation Trust (Other)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Overactive Bladder Urinary Incontinence, Stress Urinary Incontinence, Urge Urinary Retention

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

Study Type:

Observational

Actual Enrollment :

27 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Do Increased Levels of Anxiety Decrease the Reproducibility of Symptoms During Urodynamic Studies in Women?

Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Apr 1, 2016

Outcome Measures

Primary Outcome Measures

Correlate pre-test anxiety scores with the reproducibility of symptom scores from urodynamic studies in women [9 months]

Secondary Outcome Measures

The number of women who have their typical symptoms reproduced during urodynamic studies [9 months]
Number of women with abnormal (i.e. not normal) urodynamic diagnosis and high pre-test anxiety scores [9 months]
Number of women with abnormal (i.e. not normal) urodynamic diagnosis with low reproducibility of symptom scores [9 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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