Bladder Diary for Diagnosing Bladder Oversensitivity

Completed

• Conditions: Bladder Oversensitivity
• Interventions: Diagnostic Test: Three-day bladder diary

• Registration Number: NCT04981015
• Lead Sponsor: National Taiwan University Hospital

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.

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 Timeline

• Study Start: 2009-07-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-07
• Study First Submitted: 2021-07-20
• Study First Submitted QC: 2021-07-20
• Last Update Submitted: 2021-07-20
• Study First Posted: 2021-07-28
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3960

Inclusion Criteria

• Women with lower urinary tract symptoms
• Complete a urodynamic study
• Complete a 3-day bladder diary

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Exclusion Criteria

• Women with cystocele
• Chronic infection
• Incomplete data

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with lower urinary tract symptoms	Three-day bladder diary	Women with lower urinary tract symptoms without cystocele were included.

Primary Outcome Measures

Name	Time	Method
Correlation between parameters	July 2009 to December 2020	Correlation between 3-day bladder diary and urodynamic parameters

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan