Prevalence and Risk Factor of NP in Women With LUTS

NCT04104100 | Completed DMC

• 1 other identifier: 201907002RIN
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lower Urinary Tract Symptoms

Keywords

Nocturnal polyuria; Bladder diary

Outcome Measures

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.

  Between August 2007 and December 2010

Study Arms (2)

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.

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

Women with lower urinary tract symptoms

You may qualify if:

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

You may not qualify if:

• \<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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Related Publications (3)

• 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.

  PMID: 17049716 BACKGROUND

• 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.

  PMID: 30644584 BACKGROUND

• 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.

  PMID: 24684483 BACKGROUND

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ho-Hsiung Lin, PhD

  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: September 24, 2019
• First Posted: September 26, 2019
• Study Start: September 1, 2010
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share