Bladder Diary for Diagnosing Bladder Oversensitivity | NCT04981015

Studies
Bladder Diary for Diagnosing Bladder Oversensitivity

NCT04981015

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Jul 28, 2021Actual

Enrollment

3,960Actual

Phase

Not provided

Conditions

Bladder Oversensitivity

Interventions

Three-day bladder diary

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2009Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Jul 20, 2021

First Submission Date that Met QC Criteria

Jul 20, 2021

First Posted Date

Jul 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2021

Last Update Posted Date

Jul 28, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,960Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Women with lower urinary tract symptoms		Women with lower urinary tract symptoms without cystocele were included.	Diagnostic Test: Three-day bladder diary

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Three-day bladder diary	Diagnostic Test	A three-day bladder diary for recording voiding-flow pattern of a women	Women with lower urinary tract symptoms

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between parameters	Correlation between 3-day bladder diary and urodynamic parameters	July 2009 to December 2020

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

All women with lower urinary tract symptoms but without cystocele who visited the urogynecological department of a medical center for urodynamic evaluation were included.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ho-Hsiung Lin, PhD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		100	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19941278	Result	Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.
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