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Bladder Diary for Diagnosing Bladder Oversensitivity

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04981015
Collaborator
(none)
3,960
Enrollment
1
Location
138
Actual Duration (Months)
28.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Urodynamic study is an invasive procedure and applied for diagnosis of bladder oversensitivity. Bladder diary is a non-invasive measurement. The aim of this study was to elucidate whether bladder diary is a good surrogate for diagnosing bladder oversensitivity.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Three-day bladder diary

Detailed Description

Between July 2009 and December 2020, medical records of all women with lower urinary tract symptoms but without cystocele who visited the urogynecological department of a medical center for urodynamic evaluation were reviewed. Those women who have no complete data of a 3-day bladder diary were excluded from this study. Bladder oversensitivity was diagnosed if the volume of strong desire was less than 300mL. We compared the urodynamic parameters to bladder diary parameters in order to find the best correlation between these 2 measurements for the diagnosis of bladder oversensitivity.

STATA software was used for statistical analysis. Chi2 test, univariate and multivariable logistic regression tests were used for statistical analysis as appropriate. A p < 0.05 was considered as statistically significant.

Study Design

Study Type:
Observational
Actual Enrollment :
3960 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Bladder Diary Can be a Good Surrogate of Diagnosing Bladder Oversensitivity
Actual Study Start Date :
Jul 1, 2009
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Women with lower urinary tract symptoms

Women with lower urinary tract symptoms without cystocele were included.

Diagnostic Test: Three-day bladder diary
A three-day bladder diary for recording voiding-flow pattern of a women
Other Names:
  • Urodynamic study

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Correlation between parameters [July 2009 to December 2020]

      Correlation between 3-day bladder diary and urodynamic parameters

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 85 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Women with lower urinary tract symptoms

    • Complete a urodynamic study

    • Complete a 3-day bladder diary

    Exclusion Criteria:

    • Women with cystocele

    • Chronic infection

    • Incomplete data

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Ho-Hsiung Lin, PhD, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT04981015
    Other Study ID Numbers:
    • 202105069RINA
    First Posted:
    Jul 28, 2021
    Last Update Posted:
    Jul 28, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 28, 2021