Urinary Urge IncontinenceNCT06222515
Bladder Diary for Female Storage LUTS
An observational study of Urinary Urge Incontinence and Urinary Frequency More Than Once at Night, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Storage urinary symptoms are the most complained of lower urinary tract symptoms (LUTS) and need further classification. This original study aims to derive a novel classification algorism for female storage LUTS according to a 3-day bladder diary (BD). Further feasibility of the application was also evaluated. Read more about this study
- Who is it for?
- Ages 20 to 85 years, women only
- Conditions the study is for
- Urinary Urge Incontinence, Urinary Frequency More Than Once at Night, Stress Urinary Incontinence
- What is being tested?
- Bladder diary
- How many people
- 4,200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2009to 31 Dec 2021
- 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: Between July 2009 and December 2021, all women with storage LUTS who visited the urogynecological department of a medical center were included. Women without complete data of a BD were excluded from this study. The women were allocated into 12 groups according to the study flowchart based on their LUTS, including urinary urgency (UU), stress urinary incontinence(SUI), urgency urinary incontinence (UUI), nocturia (N) and frequency (F). MedCalc software was used for statistical analysis. Analysis of variance (ANOVA) was applied, and a P-value of less than 0.05 was considered as statistically significant. Post-hot analyses by the Student-Newman-Keuls test were performed only in those comparisons with p < 0.05 after ANOVA.
Who may be able to join
- Women more than 20-years-old
- With storage lower urinary tract symptoms
- Finished a 3-day bladder diary
Who cannot join
- No lower urinary tract symptoms
- Pregnant
- Incomplete data of bladder diary
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Classification Algorism Derived From 3-day Bladder Diary for Female Storage Lower Urinary Tract Symptoms and Correlations of Clinical and Urodynamic Findings
Storage urinary symptoms are the most complained of lower urinary tract symptoms (LUTS) and need further classification. This original study aims to derive a novel classification algorism for female storage LUTS according to a 3-day bladder diary (BD). Further feasibility of the application was also evaluated.
Read the detailed description
Between July 2009 and December 2021, all women with storage lower urinary tract symptoms (LUTS) who visited the urogynecological department of a medical center were included. Women without complete data of a 3-day bladder diary (BD) were excluded from this study. The women were allocated into 12 groups according to the study flowchart based on their LUTS, including urinary urgency, stress urinary incontinence, urgency urinary incontinence, nocturia and frequency. MedCalc software was used for statistical analysis. Analysis of variance (ANOVA) was applied, and a P-value of less than 0.05 was considered as statistically significant. Post-hot analyses by the Student-Newman-Keuls test were performed only in those comparisons with p < 0.05 after ANOVA.
- Conditions
- Urinary Urge Incontinence, Urinary Frequency More Than Once at Night, Stress Urinary Incontinence
- Being tested
- Bladder diary
- Keywords
- Storage, Lower urinary tract symptom, Female, Bladder diary
- Medical subject headings
- Urinary Incontinence, Urge, Nocturia, Urinary Incontinence, Stress, Lower Urinary Tract Symptoms
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 record including fluid intake, urine amount, urgency and incontinence.
| Study group | Role | What they receive |
|---|---|---|
| Women with storage lower urinary tract symptom | The women with lower urinary tract symptoms, including urinary urgency (UU), stress urinary incontinence(SUI), urgency urinary incontinence (UUI), nocturia (N) and frequency (F). Receives: Diagnostic Test: Bladder diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female lower urinary tract symptom classification
Classification of female lower urinary tract symptoms based on bladder diary, , including urinary urgency (UU), stress urinary incontinence(SUI), urgency urinary incontinence (UUI), nocturia (N) and frequency (F) and the combination of diagnoses.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Jul 2009
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Urinary Urge IncontinenceStudies 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
- 4,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pei-chi Wu, MD., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222515
- Sponsor's protocol ID
- 202303058RINC
- Status last verified
- May 2023
- First submitted
- 16 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be shared under reasonable request.
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 19941278Coyne KS, Wein AJ, Tubaro A, Sexton CC, Thompson CL, Kopp ZS, Aiyer LP. The burden of lower urinary tract symptoms: evaluating the effect of LUTS on health-related quality of life, anxiety and depression: EpiLUTS. BJU Int. 2009 Apr;103 Suppl 3:4-11. doi: 10.1111/j.1464-410X.2009.08371.x.
PubMed 19302497Hsiao SM, Lin HH. Medical treatment of female overactive bladder syndrome and treatment-related effects. J Formos Med Assoc. 2018 Oct;117(10):871-878. doi: 10.1016/j.jfma.2018.01.011. Epub 2018 Feb 15.
PubMed 29398096Hsiao SM, Su TC, Chen CH, Chang TC, Lin HH. Autonomic dysfunction and arterial stiffness in female overactive bladder patients and antimuscarinics related effects. Maturitas. 2014 Sep;79(1):65-9. doi: 10.1016/j.maturitas.2014.06.001. Epub 2014 Jun 20.
PubMed 25022469Hsiao SM, Liao SC, Chen CH, Chang TC, Lin HH. Psychometric assessment of female overactive bladder syndrome and antimuscarinics-related effects. Maturitas. 2014 Dec;79(4):428-34. doi: 10.1016/j.maturitas.2014.08.009. Epub 2014 Sep 3.
PubMed 25238744
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Classification Algorism Derived From 3-day Bladder Diary for Female Storage Lower Urinary Tract Symptoms and Correlations of Clinical and Urodynamic Findings
- ClinicalTrials.gov ID
- NCT06222515
- Acronym / sponsor ID
- 202303058RINC
- Conditions
- Urinary Urge Incontinence, Urinary Frequency More Than Once at Night, Stress Urinary Incontinence
- Keywords
- Storage, Lower urinary tract symptom, Female, Bladder diary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,200 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2009 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 24 Jan 2024 (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.
Storage urinary symptoms are the most complained of lower urinary tract symptoms (LUTS) and need further classification. This original study aims to derive a novel classification algorism for female storage LUTS according to a 3-day bladder diary (BD). Further feasibility of the application was also evaluated.
Detailed description
Between July 2009 and December 2021, all women with storage lower urinary tract symptoms (LUTS) who visited the urogynecological department of a medical center were included. Women without complete data of a 3-day bladder diary (BD) were excluded from this study. The women were allocated into 12 groups according to the study flowchart based on their LUTS, including urinary urgency, stress urinary incontinence, urgency urinary incontinence, nocturia and frequency. MedCalc software was used for statistical analysis. Analysis of variance (ANOVA) was applied, and a P-value of less than 0.05 was considered as statistically significant. Post-hot analyses by the Student-Newman-Keuls test were performed only in those comparisons with p < 0.05 after ANOVA.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with storage lower urinary tract symptom | – | Diagnostic Test: Bladder diaryThe women with lower urinary tract symptoms, including urinary urgency (UU), stress urinary incontinence(SUI), urgency urinary incontinence (UUI), nocturia (N) and frequency (F). |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between July 2009 and December 2021, all women with storage LUTS who visited the urogynecological department of a medical center were included. Women without complete data of a BD were excluded from this study. The women were allocated into 12 groups according to the study flowchart based on their LUTS, including urinary urgency (UU), stress urinary incontinence(SUI), urgency urinary incontinence (UUI), nocturia (N) and frequency (F). MedCalc software was used for statistical analysis. Analysis of variance (ANOVA) was applied, and a P-value of less than 0.05 was considered as statistically significant. Post-hot analyses by the Student-Newman-Keuls test were performed only in those comparisons with p < 0.05 after ANOVA.
Key inclusion criteria (3 listed)
- Women more than 20-years-old
- With storage lower urinary tract symptoms
- Finished a 3-day bladder diary
Key exclusion criteria (3 listed)
- No lower urinary tract symptoms
- Pregnant
- Incomplete data of bladder diary
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 record including fluid intake, urine amount, urgency and incontinence. | Diagnostic test | Women with storage lower urinary tract symptom |
Primary outcome
Female lower urinary tract symptom classification
Time frame: 3 days
Classification of female lower urinary tract symptoms based on bladder diary, , including urinary urgency (UU), stress urinary incontinence(SUI), urgency urinary incontinence (UUI), nocturia (N) and frequency (F) and the combination of diagnoses.
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 5 Feb 2024.
- Results publication: 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.
- Results publication: PubMed 19302497Coyne KS, Wein AJ, Tubaro A, Sexton CC, Thompson CL, Kopp ZS, Aiyer LP. The burden of lower urinary tract symptoms: evaluating the effect of LUTS on health-related quality of life, anxiety and depression: EpiLUTS. BJU Int. 2009 Apr;103 Suppl 3:4-11. doi: 10.1111/j.1464-410X.2009.08371.x.
- Results publication: PubMed 29398096Hsiao SM, Lin HH. Medical treatment of female overactive bladder syndrome and treatment-related effects. J Formos Med Assoc. 2018 Oct;117(10):871-878. doi: 10.1016/j.jfma.2018.01.011. Epub 2018 Feb 15.
- Results publication: PubMed 25022469Hsiao SM, Su TC, Chen CH, Chang TC, Lin HH. Autonomic dysfunction and arterial stiffness in female overactive bladder patients and antimuscarinics related effects. Maturitas. 2014 Sep;79(1):65-9. doi: 10.1016/j.maturitas.2014.06.001. Epub 2014 Jun 20.
- Results publication: PubMed 25238744Hsiao SM, Liao SC, Chen CH, Chang TC, Lin HH. Psychometric assessment of female overactive bladder syndrome and antimuscarinics-related effects. Maturitas. 2014 Dec;79(4):428-34. doi: 10.1016/j.maturitas.2014.08.009. Epub 2014 Sep 3.
- Individual participant dataSharing planned: No. The data will be shared under reasonable request.
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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.
Pei-chi Wu, MD. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Urge Incontinence and Urinary Frequency More Than Once at Night, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 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 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Female lower urinary tract symptom classification (time frame: 3 days). 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 NCT06222515, which also lists 5 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 5 Feb 2024.