NCT02540798

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 7, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

October 24, 2016

Status Verified

October 1, 2016

Enrollment Period

4 months

First QC Date

August 7, 2015

Last Update Submit

October 21, 2016

Conditions

AnxietyOveractive BladderUrinary Incontinence, StressUrinary Incontinence, UrgeUrinary Retention

Keywords

AnxietyUrodynamicsSymptom reproducibilityLower urinary tract symptomsWomen

Outcome Measures

Primary Outcomes (1)

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

    9 months

Secondary Outcomes (3)

  • 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

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sandwell and West Birmingham Hospitals NHS Trust

Birmingham, B71 4HJ, United Kingdom

Location

MeSH Terms

Conditions

Anxiety DisordersUrinary Bladder, OveractiveUrinary Incontinence, StressUrinary Incontinence, UrgeUrinary RetentionLower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Mental DisordersUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary IncontinenceUrination Disorders

Study Officials

  • Victor Olagundoye

    Sandwell and West Birmingham Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trainee Clinical Scientist

Study Record Dates

First Submitted

August 7, 2015

First Posted

September 4, 2015

Study Start

July 1, 2015

Primary Completion

November 1, 2015

Study Completion

April 1, 2016

Last Updated

October 24, 2016

Record last verified: 2016-10

Locations

GB(1)