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OpenTrials
Completed

NCT Number: NCT04104100

Prevalence and Risk Factor of NP in Women With LUTS

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.

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Key information

Conditions

Lower Urinary Tract Symptoms Pathological Conditions, Signs and Symptoms Signs and Symptoms Urological Manifestations

Age range

20 year–85 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Nocturnal polyuria

    Time frame: Between August 2007 and December 2010

    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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Sep 26, 2019
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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