Bladder Diary for Diagnosing Bladder Oversensitivity

NCT ID: NCT04981015

Last Updated: 2021-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3960 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Bladder Oversensitivity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Women with lower urinary tract symptoms

Women with lower urinary tract symptoms without cystocele were included.

Three-day bladder diary

Intervention Type DIAGNOSTIC_TEST

A three-day bladder diary for recording voiding-flow pattern of a women

Interventions

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Three-day bladder diary

A three-day bladder diary for recording voiding-flow pattern of a women

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Urodynamic study

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ho-Hsiung Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type RESULT
PMID: 19941278 (View on PubMed)

Coyne KS, Wein AJ, Tubaro A, Sexton CC, Thompson CL, Kopp ZS, Aiyer LP. The burden of lower urinary tract symptoms: evaluating the effect of LUTS on health-related quality of life, anxiety and depression: EpiLUTS. BJU Int. 2009 Apr;103 Suppl 3:4-11. doi: 10.1111/j.1464-410X.2009.08371.x.

Reference Type RESULT
PMID: 19302497 (View on PubMed)

Hsiao SM, Lin HH. Medical treatment of female overactive bladder syndrome and treatment-related effects. J Formos Med Assoc. 2018 Oct;117(10):871-878. doi: 10.1016/j.jfma.2018.01.011. Epub 2018 Feb 15.

Reference Type RESULT
PMID: 29398096 (View on PubMed)

Hsiao SM, Su TC, Chen CH, Chang TC, Lin HH. Autonomic dysfunction and arterial stiffness in female overactive bladder patients and antimuscarinics related effects. Maturitas. 2014 Sep;79(1):65-9. doi: 10.1016/j.maturitas.2014.06.001. Epub 2014 Jun 20.

Reference Type RESULT
PMID: 25022469 (View on PubMed)

Hsiao SM, Liao SC, Chen CH, Chang TC, Lin HH. Psychometric assessment of female overactive bladder syndrome and antimuscarinics-related effects. Maturitas. 2014 Dec;79(4):428-34. doi: 10.1016/j.maturitas.2014.08.009. Epub 2014 Sep 3.

Reference Type RESULT
PMID: 25238744 (View on PubMed)

Other Identifiers

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202105069RINA

Identifier Type: -

Identifier Source: org_study_id

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