NocturiaNCT03810027
Prevalence and Risk Factors Nocturnal Polyuria in Female OAB
An observational study of Nocturia, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Nocturia
- What is being tested?
- Bladder diary
- How many people
- 1,071 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2009to 31 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- More than 20-year-old
- Female
- Diagnosed with overactive bladder
Who cannot join
- Younger than 20-year-old
- Pregnant or planned to be pregnant
About this study
Official title: Prevalence and Risk Factors of Nocturnal Polyuria in Female Overactive Bladder Syndrome
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.
Read the 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.
- Conditions
- Nocturia
- Being tested
- Bladder diary
- Keywords
- Nocturnal polyuria, Overactive bladder
- Medical subject headings
- Nocturia, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder diaryDiagnostic test
3-day bladder diary
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Bladder diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nocturnal polyuria
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.
Measured: Between July 2009 and January 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start1 Jul 2009
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for NocturiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,071 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ho-Hsiung Lin, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810027
- Sponsor's protocol ID
- 201810091RIND
- Status last verified
- Dec 2018
- First submitted
- 9 Jan 2019
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19941278Powell 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.
PubMed 29331047Coyne 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.
PubMed 24456314Milsom 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.
PubMed 24007713Stewart 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.
PubMed 12811491Onukwugha 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.
PubMed 19355803Coyne 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.
PubMed 22847394
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors of Nocturnal Polyuria in Female Overactive Bladder Syndrome
- ClinicalTrials.gov ID
- NCT03810027
- Acronym / sponsor ID
- 201810091RIND
- Conditions
- Nocturia
- Keywords
- Nocturnal polyuria, Overactive bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,071 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2009 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OAB with nocturnal polyuria | – | Diagnostic Test: Bladder diaryThe 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. |
| OAB without nocturnal polyuria | – | Diagnostic Test: Bladder diaryThe 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- More than 20-year-old
- Female
- Diagnosed with overactive bladder
Key exclusion criteria (2 listed)
- Younger than 20-year-old
- Pregnant or planned to be pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bladder diary3-day bladder diary | Diagnostic test | OAB with nocturnal polyuria, OAB without nocturnal polyuria |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
- Background: PubMed 19941278Haylen 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.
- Background: PubMed 29331047Powell 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.
- Background: PubMed 24456314Coyne 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.
- Background: PubMed 24007713Milsom 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.
- Background: PubMed 12811491Stewart 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.
- Background: PubMed 19355803Onukwugha 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.
- Background: PubMed 22847394Coyne 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho-Hsiung Lin, PhD principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Nocturia, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nocturnal polyuria (time frame: Between July 2009 and January 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03810027, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2019.