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CompletedNCT04104100Updated Sep 26, 2019

Prevalence and Risk Factor of NP in Women With LUTS

An observational study in Lower Urinary Tract Symptoms, sponsored by National Taiwan University Hospital. Completed. Open to female participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-09-26.

Sponsored by National Taiwan University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
3,000
Ages
20 Years to 85 Years
Sex
Female
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Study summary

The knowledge of prevalence and risk factors of nocturnal polyuria might be important for the treatment of women with lower urinary tract symptoms (LUTS). Thus, our aim is to describe the prevalence and risk factors of nocturnal polyuria in women with LUTS.

Read the detailed description

Between September 2010 and January 2019, all women with LUTS visiting urogynecological department of a medical center for urodynamic evaluation were reviewed. Nocturnal polyuria was defined when the proportion of night-time voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of night-time voided volume over 24-hour voided volume was greater than 20% for \<65 year-old women. Backward stepwise multivariable logistic regression analysis was performed using all statistical variables in the univariate logistic regression analysis. P \< 0.05 was considered as statistical significant.

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Conditions studied

  • Lower Urinary Tract Symptoms

Keywords

  • Nocturnal polyuria
  • Bladder diary
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In context

Lower Urinary Tract Symptoms

406 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.

This study's enrollment of 3,000 is above the median of 179 across 132 observational studies indexed under Lower Urinary Tract Symptoms.

Browse Lower Urinary Tract Symptoms studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 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.

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Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women with lower urinary tract symptoms

Inclusion criteria

  • Women with lower urinary tract symptoms
  • Complete a 3-day bladder diary

Exclusion criteria

Exclusion Criteria:

  • \<20 y/o or > 85 y/o
  • Regular urethral catheterization or intermittent self-catheterization
  • Urinary tract infection or chronic inflammation in the previous 2 weeks
  • Bladder calculus
  • Neurogenic bladder due to radical hysterectomy or injury of the central nervous system
  • History of pelvic radiotherapy or a preexisting malignant pelvic tumor.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
3,000 participants (actual)
Patient registry
No

Groups and cohorts

  • Women with nocturnal polyuria

    Nocturnal polyuria was defined when the proportion of night-time voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of night-time voided volume over 24-hour voided volume was greater than 20% for \<65 year-old women.

  • Women without nocturnal polyuria

    Nocturnal polyuria was defined when the proportion of night-time voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of night-time voided volume over 24-hour voided volume was greater than 20% for \<65 year-old women.

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What researchers measure

Primary outcomes

  1. Nocturnal polyuria

    Nocturnal polyuria was defined when the proportion of night-time voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of night-time voided volume over 24-hour voided volume was greater than 20% for \<65 year-old women.

    Time frame: Between August 2007 and December 2010

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2. PubMed 17049716 ↗
  • Hashim H, Blanker MH, Drake MJ, Djurhuus JC, Meijlink J, Morris V, Petros P, Wen JG, Wein A. International Continence Society (ICS) report on the terminology for nocturia and nocturnal lower urinary tract function. Neurourol Urodyn. 2019 Feb;38(2):499-508. doi: 10.1002/nau.23917. Epub 2019 Jan 15. PubMed 30644584 ↗
  • Hofmeester I, Kollen BJ, Steffens MG, Bosch JL, Drake MJ, Weiss JP, Blanker MH. Impact of the International Continence Society (ICS) report on the standardisation of terminology in nocturia on the quality of reports on nocturia and nocturnal polyuria: a systematic review. BJU Int. 2015 Apr;115(4):520-36. doi: 10.1111/bju.12753. Epub 2015 Jan 26. PubMed 24684483 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2019, 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
NCT04104100
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Sep 26, 2019
Start date
Sep 1, 2010
Primary completion
Jan 31, 2019
Completion
Jan 31, 2019
Last update
Sep 26, 2019

Study contacts

Ho-Hsiung Lin, PhD
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
Yes
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 Aug 2019. You cannot join it, but the record below documents what was studied.

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