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CompletedNCT06222515Updated Feb 5, 2024

Bladder Diary for Female Storage LUTS

An observational study in Urinary Urge Incontinence, Urinary Frequency More Than Once at Night and Stress Urinary Incontinence, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to female participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-02-05.

Sponsored by National Taiwan University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
4,200
Ages
20 Years to 85 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Storage
  • Lower urinary tract symptom
  • Female
  • Bladder diary
03

In context

Urinary Incontinence, Urge

242 studies on the registry are indexed under Urinary Incontinence, Urge; 39 are open to participants now.

This study's enrollment of 4,200 is above the median of 133 across 39 observational studies indexed under Urinary Incontinence, Urge.

Browse Urinary Incontinence, Urge studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
Female
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • No lower urinary tract symptoms
  • Pregnant
  • Incomplete data of bladder diary
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
4,200 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testBladder diary

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

06

What researchers measure

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.

    Time frame: 3 days

07

Study locations

1 site
  • Pei-chi Wu
    Taipei, 100, Taiwan
08

References and documents

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. PubMed 19941278 ↗
  • 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. PubMed 19302497 ↗
  • 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. PubMed 29398096 ↗
  • 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. PubMed 25022469 ↗
  • 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. PubMed 25238744 ↗

Individual participant data

Plan to share: No — The data will be shared under reasonable request.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06222515
Responsible party
Sponsor
First posted
Jan 24, 2024
Start date
Jul 1, 2009
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Feb 5, 2024

Study contacts

Pei-chi Wu, MD.
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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