Prevalence and Risk Factors Nocturnal Polyuria in Female OAB

NCT ID: NCT03810027

Last Updated: 2019-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1071 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-01

Study Completion Date

2018-01-31

Brief Summary

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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

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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.

Conditions

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Nocturia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Bladder diary

Intervention Type DIAGNOSTIC_TEST

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.

Bladder diary

Intervention Type DIAGNOSTIC_TEST

3-day bladder diary

Interventions

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Bladder diary

3-day bladder diary

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ho-Hsiung Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

References

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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.

Reference Type BACKGROUND
PMID: 19941278 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29331047 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24456314 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24007713 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12811491 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19355803 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22847394 (View on PubMed)

Other Identifiers

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201810091RIND

Identifier Type: -

Identifier Source: org_study_id

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