Do Patient Anxiety Levels Decrease Urodynamic Test Reproducibility?

Completed

• Conditions: Urinary Retention; Anxiety; Urinary Incontinence, Urge; Overactive Bladder; Urinary Incontinence, Stress

• Registration Number: NCT02540798
• Lead Sponsor: Sandwell & West Birmingham Hospitals NHS Trust

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-08-07
• Study First Submitted QC: 2015-09-01
• Study First Posted: 2015-09-04
• Primary Completion: 2015-11
• Study Completion: 2016-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-21
• Last Update Posted: 2016-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlate pre-test anxiety scores with the reproducibility of symptom scores from urodynamic studies in women	9 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sandwell and West Birmingham Hospitals NHS Trust; 🇬🇧 Birmingham, United Kingdom