Overactive BladderRESORTNCT00901251
Reproducibility Study of Over Active Bladder Symptom Score [OABSS]
An observational study of Overactive Bladder, run by Astellas Pharma Inc at 5 sites in China.
Trial summary
The purpose of this study is to evaluate the reproducibility of over active bladder symptom score (OABSS) in Asian countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- How many people
- 50 participants
- Where
- 5 sitesChina
- Study dates
- Jan 2009to May 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Symptomatic OAB patients having urgency episodes
Who may be able to join
- Symptoms OAB for 3 months or longer
- At least 1 urgency episode in last 3 days
- Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:
- Number of micturition ≥8 times/day
- Number of urgency episode in 3 days ≥1
Who cannot join
- Indwelling catheters or practicing intermittent self-catheterization
- Symptomatic urinary tract infection, chronic inflammation
- Diabetic neuropathy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Study site
Beijing
Study site
Chongqing
Study site
Shanghai
Study site
Shenyang
Study site
Wuhan
About this study
Official title: Reproducibility Study of OABSS and Its Response to Treatment - Part 1: Reproducibility -
The purpose of this study is to evaluate the reproducibility of over active bladder symptom score (OABSS) in Asian countries.
- Conditions
- Overactive Bladder
- Keywords
- OABSS
- Medical subject headings
- Urinary Bladder, Overactive
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 |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
OABSS
Measured: Weeks of 0 and 2
Secondary outcomes (1)
3-day micturition diary
Measured: 2 times in 2-week interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma China, Inc.
- Investigators
- Use Central Contact, Study chair, Astellas Pharma China, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901251
- Sponsor's protocol ID
- VESOABCN02
- Acronym
- RESORT
- Status last verified
- Mar 2011
- First submitted
- 11 May 2009
- Last updated
- 15 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility Study of OABSS and Its Response to Treatment - Part 1: Reproducibility -
- ClinicalTrials.gov ID
- NCT00901251
- Acronym / sponsor ID
- RESORT / VESOABCN02
- Conditions
- Overactive Bladder
- Keywords
- OABSS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma China, Inc.
- Study start
- Jan 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 13 May 2009 (estimated)
- 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 purpose of this study is to evaluate the reproducibility of over active bladder symptom score (OABSS) in Asian countries.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic OAB patients having urgency episodes
Key inclusion criteria (5 listed)
- Symptoms OAB for 3 months or longer
- At least 1 urgency episode in last 3 days
- Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:
Key exclusion criteria (3 listed)
- Indwelling catheters or practicing intermittent self-catheterization
- Symptomatic urinary tract infection, chronic inflammation
- Diabetic neuropathy
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
OABSS
Time frame: Weeks of 0 and 2
1 secondary outcome
3-day micturition diary
Time frame: 2 times in 2-week interval
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 15 Mar 2011.
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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.
Use Central Contact study chair
Astellas Pharma China, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder, run by Astellas Pharma Inc at 5 sites in China.
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 5 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 15 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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?
OABSS (time frame: Weeks of 0 and 2). 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 15 Mar 2011.