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Completed

NCT Number: NCT02540798

Do Patient Anxiety Levels Decrease Urodynamic Test Reproducibility?

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlate pre-test anxiety scores with the reproducibility of symptom scores from urodynamic studies in women

    Time frame: 9 months

Secondary outcomes

  1. The number of women who have their typical symptoms reproduced during urodynamic studies

    Time frame: 9 months

  2. Number of women with abnormal (i.e. not normal) urodynamic diagnosis and high pre-test anxiety scores

    Time frame: 9 months

  3. Number of women with abnormal (i.e. not normal) urodynamic diagnosis with low reproducibility of symptom scores

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Sandwell & West Birmingham Hospitals NHS Trust

Other

Collaborators

  • Sheffield Teaching Hospitals NHS Foundation Trust

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Sep 4, 2015
Registry last updated
Oct 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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