Bladder Diary for Female Storage LUTS

Completed

• Conditions: Urinary Urge Incontinence; Urinary Frequency More Than Once at Night; Stress Urinary Incontinence
• Interventions: Diagnostic Test: Bladder diary

• Registration Number: NCT06222515
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-07-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2023-05
• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-24
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with storage lower urinary tract symptom	Bladder diary	The women with lower urinary tract symptoms, including urinary urgency (UU), stress urinary incontinence(SUI), urgency urinary incontinence (UUI), nocturia (N) and frequency (F).

Primary Outcome Measures

Name	Time	Method
Female lower urinary tract symptom classification	3 days	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.

Trial Locations

Locations (1)

Pei-chi Wu; 🇨🇳 Taipei, Taiwan