Clinical trial NCT04104100: Prevalence and Risk Factor of NP in Women With LUTS
Official title: Prevalence and Risk Factors of Nocturnal Polyuria in Women With Lower Urinary Tracts Symptoms Based on Bladder Diary
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Urinary Tract Symptoms
Keywords: Nocturnal polyuria
Bladder diary
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with lower urinary tract symptoms

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

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.

Primary outcomes:
measure: Nocturnal polyuria
timeFrame: Between August 2007 and December 2010
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Ho-Hsiung Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.