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NCT06222515 Clinical Trial

Bladder Diary for Female Storage LUTS

Stress Urinary Incontinence Clinical Trial

Official title:
Novel Classification Algorism Derived From 3-day Bladder Diary for Female Storage Lower Urinary Tract Symptoms and Correlations of Clinical and Urodynamic Findings

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06222515
Other study ID # 202303058RINC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2009
Est. completion date December 31, 2021

Study information
Verified date May 2023
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Storage urinary symptoms are the most complained of lower urinary tract symptoms (LUTS) and need further classification. This original study aims to derive a novel classification algorism for female storage LUTS according to a 3-day bladder diary (BD). Further feasibility of the application was also evaluated.

Description:

Between July 2009 and December 2021, all women with storage lower urinary tract symptoms (LUTS) who visited the urogynecological department of a medical center were included. Women without complete data of a 3-day bladder diary (BD) were excluded from this study. The women were allocated into 12 groups according to the study flowchart based on their LUTS, including urinary urgency, stress urinary incontinence, urgency urinary incontinence, nocturia and frequency. MedCalc software was used for statistical analysis. Analysis of variance (ANOVA) was applied, and a P-value of less than 0.05 was considered as statistically significant. Post-hot analyses by the Student-Newman-Keuls test were performed only in those comparisons with p < 0.05 after ANOVA.

Recruitment information / eligibility
Status Completed
Enrollment 4200
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 85 Years
Eligibility Inclusion Criteria: - Women more than 20-years-old - With storage lower urinary tract symptoms - Finished a 3-day bladder diary Exclusion Criteria: - No lower urinary tract symptoms - Pregnant - Incomplete data of bladder diary

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Bladder diary
3-day bladder diary record including fluid intake, urine amount, urgency and incontinence.

Locations
Country Name City State
Taiwan Pei-chi Wu Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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: — View Citation

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)/Internation — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Female lower urinary tract symptom classification Classification of female lower urinary tract symptoms based on bladder diary, , including urinary urgency (UU), stress urinary incontinence(SUI), urgency urinary incontinence (UUI), nocturia (N) and frequency (F) and the combination of diagnoses. 3 days
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