Lower Urinary Tract SymptomsNCT04104100
Prevalence and Risk Factor of NP in Women With LUTS
An observational study of Lower Urinary Tract Symptoms, run by National Taiwan University Hospital.
Trial summary
The knowledge of prevalence and risk factors of nocturnal polyuria might be important for the treatment of women with lower urinary tract symptoms (LUTS). Thus, our aim is to describe the prevalence and risk factors of nocturnal polyuria in women with LUTS. Read more about this study
- Who is it for?
- Ages 20 to 85 years, women only
- Conditions the study is for
- Lower Urinary Tract Symptoms
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2010to 31 Jan 2019
- 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 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with lower urinary tract symptoms
Who may be able to join
- Women with lower urinary tract symptoms
- Complete a 3-day bladder diary
Who cannot join
- <20 y/o or > 85 y/o
- Regular urethral catheterization or intermittent self-catheterization
- Urinary tract infection or chronic inflammation in the previous 2 weeks
- Bladder calculus
- Neurogenic bladder due to radical hysterectomy or injury of the central nervous system
- History of pelvic radiotherapy or a preexisting malignant pelvic tumor.
About this study
Official title: Prevalence and Risk Factors of Nocturnal Polyuria in Women With Lower Urinary Tracts Symptoms Based on Bladder Diary
The knowledge of prevalence and risk factors of nocturnal polyuria might be important for the treatment of women with lower urinary tract symptoms (LUTS). Thus, our aim is to describe the prevalence and risk factors of nocturnal polyuria in women with LUTS.
Read the detailed description
Between September 2010 and January 2019, all women with LUTS visiting urogynecological department of a medical center for urodynamic evaluation were reviewed. Nocturnal polyuria was defined when the proportion of night-time voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of night-time voided volume over 24-hour voided volume was greater than 20% for <65 year-old women. Backward stepwise multivariable logistic regression analysis was performed using all statistical variables in the univariate logistic regression analysis. P < 0.05 was considered as statistical significant.
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Nocturnal polyuria, Bladder diary
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with nocturnal polyuria | Nocturnal polyuria was defined when the proportion of night-time voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of night-time voided volume over 24-hour voided volume was greater than 20% for <65 year-old women. | |
| Women without nocturnal polyuria | Nocturnal polyuria was defined when the proportion of night-time voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of night-time voided volume over 24-hour voided volume was greater than 20% for <65 year-old women. |
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 night-time voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of night-time voided volume over 24-hour voided volume was greater than 20% for <65 year-old women.
Measured: Between August 2007 and December 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Sep 2010
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract SymptomsStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 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
- NCT04104100
- Sponsor's protocol ID
- 201907002RIN
- Status last verified
- Aug 2019
- First submitted
- 24 Sep 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.
PubMed 17049716Hashim H, Blanker MH, Drake MJ, Djurhuus JC, Meijlink J, Morris V, Petros P, Wen JG, Wein A. International Continence Society (ICS) report on the terminology for nocturia and nocturnal lower urinary tract function. Neurourol Urodyn. 2019 Feb;38(2):499-508. doi: 10.1002/nau.23917. Epub 2019 Jan 15.
PubMed 30644584Hofmeester I, Kollen BJ, Steffens MG, Bosch JL, Drake MJ, Weiss JP, Blanker MH. Impact of the International Continence Society (ICS) report on the standardisation of terminology in nocturia on the quality of reports on nocturia and nocturnal polyuria: a systematic review. BJU Int. 2015 Apr;115(4):520-36. doi: 10.1111/bju.12753. Epub 2015 Jan 26.
PubMed 24684483
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors of Nocturnal Polyuria in Women With Lower Urinary Tracts Symptoms Based on Bladder Diary
- ClinicalTrials.gov ID
- NCT04104100
- Acronym / sponsor ID
- 201907002RIN
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- Nocturnal polyuria, Bladder diary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2010 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 26 Sep 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.
The knowledge of prevalence and risk factors of nocturnal polyuria might be important for the treatment of women with lower urinary tract symptoms (LUTS). Thus, our aim is to describe the prevalence and risk factors of nocturnal polyuria in women with LUTS.
Detailed description
Between September 2010 and January 2019, all women with LUTS visiting urogynecological department of a medical center for urodynamic evaluation were reviewed. Nocturnal polyuria was defined when the proportion of night-time voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of night-time voided volume over 24-hour voided volume was greater than 20% for <65 year-old women. Backward stepwise multivariable logistic regression analysis was performed using all statistical variables in the univariate logistic regression analysis. P < 0.05 was considered as statistical significant.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with nocturnal polyuria | – | –Nocturnal polyuria was defined when the proportion of night-time voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of night-time voided volume over 24-hour voided volume was greater than 20% for <65 year-old women. |
| Women without nocturnal polyuria | – | –Nocturnal polyuria was defined when the proportion of night-time voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of night-time voided volume over 24-hour voided volume was greater than 20% for <65 year-old women. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with lower urinary tract symptoms
Key inclusion criteria (2 listed)
- Women with lower urinary tract symptoms
- Complete a 3-day bladder diary
Key exclusion criteria (6 listed)
- <20 y/o or > 85 y/o
- Regular urethral catheterization or intermittent self-catheterization
- Urinary tract infection or chronic inflammation in the previous 2 weeks
- Bladder calculus
- Neurogenic bladder due to radical hysterectomy or injury of the central nervous system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nocturnal polyuria
Time frame: Between August 2007 and December 2010
Nocturnal polyuria was defined when the proportion of night-time voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of night-time 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 26 Sep 2019.
- Background: PubMed 17049716Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.
- Background: PubMed 30644584Hashim H, Blanker MH, Drake MJ, Djurhuus JC, Meijlink J, Morris V, Petros P, Wen JG, Wein A. International Continence Society (ICS) report on the terminology for nocturia and nocturnal lower urinary tract function. Neurourol Urodyn. 2019 Feb;38(2):499-508. doi: 10.1002/nau.23917. Epub 2019 Jan 15.
- Background: PubMed 24684483Hofmeester I, Kollen BJ, Steffens MG, Bosch JL, Drake MJ, Weiss JP, Blanker MH. Impact of the International Continence Society (ICS) report on the standardisation of terminology in nocturia on the quality of reports on nocturia and nocturnal polyuria: a systematic review. BJU Int. 2015 Apr;115(4):520-36. doi: 10.1111/bju.12753. Epub 2015 Jan 26.
- 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 Lower Urinary Tract Symptoms, 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 2 inclusion and 6 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 26 Sep 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 August 2007 and December 2010). 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 NCT04104100, which also lists 3 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 26 Sep 2019.