Urinary Bladder, OveractiveOABNCT03560778
Comparisons of Urodynamic, Bladder Diary, Quality of Life Parameters Between OAB-wet and OAB-dry Female Patients
An observational study of Urinary Bladder, Overactive, run by National Taiwan University Hospital.
Trial summary
A small bladder capacity and more frequent urgency episodes were predictors of OAB-wet, and the above findings might indicate that OAB-wet and OAB-dry are a continuum of OAB. Older age, high maximum flow rate, high detrusor pressure at maximum flow rate and the presence of urodynamic stress incontinence were also… Read more about this study
- Who is it for?
- Ages 20 to 99 years, women only
- Conditions the study is for
- Urinary Bladder, Overactive
- How many people
- 623 participants
- Where
- No sites listed yet
- Study dates
- 5 May 2014to 5 Apr 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with OAB who completed a 3-day bladder diary and underwent urodynamic studies at the urogynecologic outpatient clinics of the Department of Obstetrics and Gynecology of a medical center
Who may be able to join
- The diagnosis of overactive bladder disease
- Female patient of more than 20 year-old
Who cannot join
- Dominant symptoms with stress urinary incontinence (SUI)
- Regular urethral catheterization or intermittent self-catheterization
- Urinary tract infection or chronic inflammation in the previous 2 weeks
- Bladder calculus
- A history of pelvic radiotherapy
- A preexisting malignant pelvic tumor.
About this study
A small bladder capacity and more frequent urgency episodes were predictors of OAB-wet, and the above findings might indicate that OAB-wet and OAB-dry are a continuum of OAB. Older age, high maximum flow rate, high detrusor pressure at maximum flow rate and the presence of urodynamic stress incontinence were also independent predictors for OAB-wet, and the above might indicate that OAB-wet and OAB-dry have at least partly different underlying pathophysiologies.
Read the detailed description
Aims: To identify factors predicting the presence of OAB-wet and to further derive the underlying pathophysiology in OAB-wet vs. OAB-dry.
Methods: Between September 2007 and September 2013, the medical records of women with OAB who completed a 3-day bladder diary and underwent urodynamic studies in a tertiary referral center will be reviewed. OAB-wet will be diagnosed in patients who complained of at least one episode of urgency incontinence in the previous month; otherwise, OAB-dry is diagnosed. Multivariate logistic regression analysis will be used to predict the presence of OAB-wet.
- Conditions
- Urinary Bladder, Overactive
- Keywords
- Urinary Bladder, Overactive, Urinary Incontinence, Urge, Urodynamics
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the difference of urodynamic parameters between OAB-wet and OAB-dry
The variables of urodynamic study included maximum flow rate, average flow rate, voided volume, volume of strong to desire, detrusor pressure at maximum flow during voiding cystometry (PdetQmax), Valsalva leak point pressure (VLPP), maximal urethral pressure (MUP), maximal urethral closure pressure (MUCP), functional profile length, urethral closure pressure area (UCPA), continence length, continence area, pressure transmission ratio (PTR) at MUP, and electromyography (EMG). The urodynamic parameters will be interpreted together to get a complete urodynamic report and diagnosis, thus to compare the difference between OAB-wet and OAB-dry
Measured: 1 week
Compare the difference of bladder diary parameters between OAB-wet and OAB-dry
The 3-day bladder diary parameters included maximum daytime voided volume excluding the morning void derived from 3-day bladder diaries (DVVmax), urgency episodes, urgency incontinence episodes, daytime frequency, nocturia, total voided volume and total water intake. The bladder diary parameters will be interpreted together to get a complete report, such as urinary urgency and nocturia, thus to compare the difference between OAB-wet and OAB-dry
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start5 May 2014
- Primary completion5 Apr 2018
- Study completion5 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, OveractiveStudies 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
- 623 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560778
- Sponsor's protocol ID
- 201404012RINC
- Acronym
- OAB
- Status last verified
- Apr 2018
- First submitted
- 25 Apr 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of Urodynamic, Bladder Diary, Quality of Life Parameters Between OAB-wet and OAB-dry Female Patients
- ClinicalTrials.gov ID
- NCT03560778
- Acronym / sponsor ID
- OAB / 201404012RINC
- Conditions
- Urinary Bladder, Overactive
- Keywords
- Urinary Bladder, Overactive, Urinary Incontinence, Urge, Urodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 623 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 5 May 2014 (actual)
- Primary completion
- 5 Apr 2018 (actual)
- Study completion
- 5 Apr 2018 (actual)
- First posted
- 18 Jun 2018 (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.
A small bladder capacity and more frequent urgency episodes were predictors of OAB-wet, and the above findings might indicate that OAB-wet and OAB-dry are a continuum of OAB. Older age, high maximum flow rate, high detrusor pressure at maximum flow rate and the presence of urodynamic stress incontinence were also independent predictors for OAB-wet, and the above might indicate that OAB-wet and OAB-dry have at least partly different underlying pathophysiologies.
Detailed description
Aims: To identify factors predicting the presence of OAB-wet and to further derive the underlying pathophysiology in OAB-wet vs. OAB-dry.
Methods: Between September 2007 and September 2013, the medical records of women with OAB who completed a 3-day bladder diary and underwent urodynamic studies in a tertiary referral center will be reviewed. OAB-wet will be diagnosed in patients who complained of at least one episode of urgency incontinence in the previous month; otherwise, OAB-dry is diagnosed. Multivariate logistic regression analysis will be used to predict the presence of OAB-wet.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with OAB who completed a 3-day bladder diary and underwent urodynamic studies at the urogynecologic outpatient clinics of the Department of Obstetrics and Gynecology of a medical center
Key inclusion criteria (2 listed)
- The diagnosis of overactive bladder disease
- Female patient of more than 20 year-old
Key exclusion criteria (6 listed)
- Dominant symptoms with stress urinary incontinence (SUI)
- Regular urethral catheterization or intermittent self-catheterization
- Urinary tract infection or chronic inflammation in the previous 2 weeks
- Bladder calculus
- A history of pelvic radiotherapy
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
Compare the difference of urodynamic parameters between OAB-wet and OAB-dry
Time frame: 1 week
The variables of urodynamic study included maximum flow rate, average flow rate, voided volume, volume of strong to desire, detrusor pressure at maximum flow during voiding cystometry (PdetQmax), Valsalva leak point pressure (VLPP), maximal urethral pressure (MUP), maximal urethral closure pressure (MUCP), functional profile length, urethral closure pressure area (UCPA), continence length, continence area, pressure transmission ratio (PTR) at MUP, and electromyography (EMG). The urodynamic parameters will be interpreted together to get a complete urodynamic report and diagnosis, thus to compare the difference between OAB-wet and OAB-dry
Compare the difference of bladder diary parameters between OAB-wet and OAB-dry
Time frame: 1 week
The 3-day bladder diary parameters included maximum daytime voided volume excluding the morning void derived from 3-day bladder diaries (DVVmax), urgency episodes, urgency incontinence episodes, daytime frequency, nocturia, total voided volume and total water intake. The bladder diary parameters will be interpreted together to get a complete report, such as urinary urgency and nocturia, thus to compare the difference between OAB-wet and OAB-dry
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 Jun 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder, Overactive, 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 Jun 2018. 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?
Compare the difference of urodynamic parameters between OAB-wet and OAB-dry (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2018.