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Prevalence and Risk Factors Nocturnal Polyuria in Female OAB

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ClinicalTrials.gov Identifier: NCT03810027
Recruitment Status : Completed
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date January 9, 2019
First Posted Date January 18, 2019
Last Update Posted Date January 18, 2019
Actual Study Start Date July 1, 2009
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 17, 2019)
Nocturnal polyuria [ Time Frame: Between July 2009 and January 2018 ]
Nocturnal polyuria was defined when the proportion of nighttime voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of nighttime voided volume over 24-hour voided volume was greater than 20% for <65 year-old women.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence and Risk Factors Nocturnal Polyuria in Female OAB
Official Title Prevalence and Risk Factors of Nocturnal Polyuria in Female Overactive Bladder Syndrome
Brief Summary Nocturnal polyuria may decrease the treatment efficacy of overactive bladder syndrome (OAB); and adjuvant medication, such as desmopressin, may be needed for the treatment of nocturnal polyuria. The knowledge of prevalence and risk factors of nocturnal polyuria might be important for the treatment of OAB. Thus, our aim is to describe the prevalence and risk factors of nocturnal polyuria in women with OAB.
Detailed Description

Between July 2009 and January 2018, all women with OAB visiting a medical center for evaluation were reviewed. The classification of OAB-wet or OAB-dry is based on the record of the three-day bladder diary of each patient. The diagnosis of OAB in each patient was based on the presence of at least one episode of urgency in her three-day bladder diary and with the absence of stress urinary incontinence. The presence of at least one episode of urgency associated incontinence was defined to be OAB-wet, otherwise, OAB-dry.

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

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Between July 2009 and January 2018, all women elder than 20-year-old with OAB visiting a medical center for evaluation were enrolled.
Condition Nocturia
Intervention Diagnostic Test: Bladder diary
3-day bladder diary
Study Groups/Cohorts
  • OAB with nocturnal polyuria
    The diagnosis of OAB in each patient was based on the presence of at least one episode of urgency in her three-day bladder diary and with the absence of stress urinary incontinence. Nocturnal polyuria was defined when the proportion of nighttime voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of nighttime voided volume over 24-hour voided volume was greater than 20% for <65 year-old women. Precence of nocturnal polyuria will be classified in this group.
    Intervention: Diagnostic Test: Bladder diary
  • OAB without nocturnal polyuria
    The diagnosis of OAB in each patient was based on the presence of at least one episode of urgency in her three-day bladder diary and with the absence of stress urinary incontinence. Nocturnal polyuria was defined when the proportion of nighttime voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of nighttime voided volume over 24-hour voided volume was greater than 20% for <65 year-old women. Absence of nocturnal polyuria will be classified in this group.
    Intervention: Diagnostic Test: Bladder diary
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 17, 2019)
1071
Original Actual Enrollment Same as current
Actual Study Completion Date January 31, 2018
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. More than 20-year-old
  2. Female
  3. Diagnosed with overactive bladder

Exclusion Criteria:

  1. Younger than 20-year-old
  2. Pregnant or planned to be pregnant
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03810027
Other Study ID Numbers 201810091RIND
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Ho-Hsiung Lin, PhD National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date December 2018