Do Patient Anxiety Levels Decrease Urodynamic Test Reproducibility?

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom, B71 4HJ
    • Sandwell and West Birmingham Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlate pre-test anxiety scores with the reproducibility of symptom scores from urodynamic studies in women	9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Sandwell & West Birmingham Hospitals NHS Trust
• Collaborators: Sheffield Teaching Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Victor Olagundoye, Sandwell and West Birmingham Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: August 7, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 4, 2015

Study Record Updates

• Last Update Posted (Estimate): October 24, 2016
• Last Update Submitted That Met QC Criteria: October 21, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Anxiety; Women; Urodynamics; Lower urinary tract symptoms; Symptom reproducibility
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Bladder, Overactive; Urinary Incontinence; Anxiety Disorders; Enuresis; Urinary Incontinence, Stress; Urinary Retention; Urinary Incontinence, Urge
• Other Study ID Numbers: SandwellWBNHS