- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03810027
Prevalence and Risk Factors Nocturnal Polyuria in Female OAB
Prevalence and Risk Factors of Nocturnal Polyuria in Female Overactive Bladder Syndrome
Study Overview
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- More than 20-year-old
- Female
- Diagnosed with overactive bladder
Exclusion Criteria:
- Younger than 20-year-old
- Pregnant or planned to be pregnant
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
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.
|
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.
|
3-day bladder diary
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Between July 2009 and January 2018
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.
- Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. doi: 10.1007/s00345-002-0301-4. Epub 2002 Nov 15.
- Powell LC, Szabo SM, Walker D, Gooch K. The economic burden of overactive bladder in the United States: A systematic literature review. Neurourol Urodyn. 2018 Apr;37(4):1241-1249. doi: 10.1002/nau.23477. Epub 2018 Jan 13.
- Coyne KS, Wein A, Nicholson S, Kvasz M, Chen CI, Milsom I. Economic burden of urgency urinary incontinence in the United States: a systematic review. J Manag Care Pharm. 2014 Feb;20(2):130-40. doi: 10.18553/jmcp.2014.20.2.130.
- Milsom I, Coyne KS, Nicholson S, Kvasz M, Chen CI, Wein AJ. Global prevalence and economic burden of urgency urinary incontinence: a systematic review. Eur Urol. 2014 Jan;65(1):79-95. doi: 10.1016/j.eururo.2013.08.031. Epub 2013 Aug 27.
- Onukwugha E, Zuckerman IH, McNally D, Coyne KS, Vats V, Mullins CD. The total economic burden of overactive bladder in the United States: a disease-specific approach. Am J Manag Care. 2009 Mar;15(4 Suppl):S90-7.
- Coyne KS, Sexton CC, Bell JA, Thompson CL, Dmochowski R, Bavendam T, Chen CI, Quentin Clemens J. The prevalence of lower urinary tract symptoms (LUTS) and overactive bladder (OAB) by racial/ethnic group and age: results from OAB-POLL. Neurourol Urodyn. 2013 Mar;32(3):230-7. doi: 10.1002/nau.22295. Epub 2012 Jul 27.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201810091RIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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