Bladder Diary for Female Storage LUTS

NCT06222515 | Completed

• 1 other identifier: 202303058RINC
• Study Type: observational
• Target: 4,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Urge Incontinence; Urinary Frequency More Than Once at Night; Stress Urinary Incontinence

Keywords

Storage; Lower urinary tract symptom; Female; Bladder diary

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Bladder diary DIAGNOSTIC_TEST

3-day bladder diary record including fluid intake, urine amount, urgency and incontinence.

Women with storage lower urinary tract symptom

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Women more than 20-years-old
• With storage lower urinary tract symptoms
• Finished a 3-day bladder diary

You may not qualify if:

• No lower urinary tract symptoms
• Pregnant
• Incomplete data of bladder diary

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Pei-chi Wu

Taipei, 100, Taiwan

Location

Related Publications (5)

• 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.

  PMID: 19941278 RESULT

• 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.

  PMID: 19302497 RESULT

• 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.

  PMID: 29398096 RESULT

• 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.

  PMID: 25022469 RESULT

• 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.

  PMID: 25238744 RESULT

MeSH Terms

Conditions

Urinary Incontinence, Urge; Nocturia; Urinary Incontinence, Stress; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pei-chi Wu, MD.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 24, 2024
• Study Start: July 1, 2009
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 5, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)