- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03807024
Age-specific Prevalence and Comparisons of UDS and Bladder Diary Between OAB-wet and -Dry Women
January 14, 2019 updated by: National Taiwan University Hospital
Age-specific Prevalence and Comparisons of Urodynamics and Bladder Diary Between Overactive Bladder-wet and -Dry Women Based on Bladder Diary
The knowledge of the age-specific prevalence of overactive bladder syndrome (OAB)-wet and -dry women is important for understanding the impact of aging on OAB.
Thus, our aim is to describe clinically differences between OAB-wet and -dry women.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
1071
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Between July 2009 and January 2018, all women older than 20-year-old with OAB visiting a medical center for evaluation were enrolled.
Description
Inclusion Criteria:
- More than 20-year-old
- Female
- Diagnosed with overactive bladder by bladder diary
Exclusion Criteria:
- Younger than 20-year-old
- Pregnant or planned to be pregnant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
OAB-wet
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.
|
3-day bladder diary: 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
Other Names:
|
OAB-dry
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 absence of urgency associated incontinence was defined to be OAB-dry.
|
3-day bladder diary: 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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnosis of OAB
Time Frame: Between July 2009 and January 2018
|
Diagnosis of OAB according to ICS terminology guideline: Urgency, with or without urge incontinence, usually with frequency and nocturia, can be described as the overactive bladder syndrome, urge syndrome or urgency-frequency syndrome
|
Between July 2009 and January 2018
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age-specific comparison
Time Frame: Between July 2009 and January 2018
|
Use questionnaire and urodynamic study to evaluate if there is difference between OAB-wet and OAB-dry women
|
Between July 2009 and January 2018
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2009
Primary Completion (Actual)
January 1, 2018
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
January 9, 2019
First Submitted That Met QC Criteria
January 14, 2019
First Posted (Actual)
January 16, 2019
Study Record Updates
Last Update Posted (Actual)
January 16, 2019
Last Update Submitted That Met QC Criteria
January 14, 2019
Last Verified
December 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201810084RIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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