Prevalence and Risk Factor of NP in Women With LUTS

Lower Urinary Tract Symptoms Clinical Trial

Official title:

Prevalence and Risk Factors of Nocturnal Polyuria in Women With Lower Urinary Tracts Symptoms Based on Bladder Diary

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04104100
• Other study ID #: 201907002RIN
• Status: Completed
• Start date: September 1, 2010
• Est. completion date: January 31, 2019

Study information

• Verified date: August 2019
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

References & Publications (3)

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. — View 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. Review. — View 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. Epub 2006 Oct 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Between August 2007 and December 2010