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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

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.

Condition or disease Intervention/treatment
Nocturia Diagnostic Test: Bladder diary

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.


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Study Type : Observational
Actual Enrollment : 1071 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Prevalence and Risk Factors of Nocturnal Polyuria in Female Overactive Bladder Syndrome
Actual Study Start Date : July 1, 2009
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Diagnostic Test: Bladder diary
3-day 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.
Diagnostic Test: Bladder diary
3-day bladder diary




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810027


Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Ho-Hsiung Lin, PhD National Taiwan University Hospital

Publications:

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03810027     History of Changes
Other Study ID Numbers: 201810091RIND
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
Nocturnal polyuria
Overactive bladder
Additional relevant MeSH terms:
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Polyuria
Nocturia
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urination Disorders
Urologic Diseases