Bladder Diary for Female Storage LUTS

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

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence; Urinary Urge Incontinence; Urinary Frequency More Than Once at Night
• Intervention / Treatment: Diagnostic test: Bladder diary

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 Type: Observational
• Enrollment (Actual): 4200

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Pei-chi Wu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Between July 2009 and December 2021, all women with storage LUTS who visited the urogynecological department of a medical center were included. Women without complete data of a 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 (UU), stress urinary incontinence(SUI), urgency urinary incontinence (UUI), nocturia (N) and frequency (F). 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women with storage lower urinary tract symptom; The women with lower urinary tract symptoms, including urinary urgency (UU), stress urinary incontinence(SUI), urgency urinary incontinence (UUI), nocturia (N) and frequency (F).	Diagnostic test: Bladder diary; 3-day bladder diary record including fluid intake, urine amount, urgency and incontinence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Pei-chi Wu, MD., National Taiwan University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2009
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: January 16, 2024
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Female; Storage; Bladder diary; Lower urinary tract symptom
• Additional Relevant MeSH Terms: Urologic Diseases; Urological Manifestations; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Lower Urinary Tract Symptoms; Urinary Incontinence, Stress; Urinary Incontinence, Urge; Nocturia
• Other Study ID Numbers: 202303058RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will be shared under reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No