Overactive BladderRESORT-2NCT01122563
A Study to Evaluate Response of Overactive Bladder Symptom Score (OABSS) to Treatment
An observational study of Overactive Bladder, run by Astellas Pharma Inc at 3 sites in Indonesia.
Trial summary
This study is to evaluate change of overactive bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Solifenacin
- Type of treatment
- Pill or oral medicine
- How many people
- 55 participants
- Where
- 3 sitesIndonesia
- Study dates
- Sep 2009to Jan 2011
- 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 3 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 episodes in 3 days ≥3
Who cannot join
- Significant stress incontinence or mixed stress/urge incontinence
- Subject with indwelling catheters or practicing intermittent self-catheterization
- Symptomatic urinary tract infection, chronic inflammation
- Diabetic neuropathy
- Subjects who are prohibited from taking solifenacin as contraindications
- Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks
- Participation in any clinical trial in 30 days except for Part-1 of RESORT
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: Reproducibility Study of OABSS and Its Response to Treatment in Indonesia - Part 2: Responsiveness
This study is to evaluate change of overactive bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.
- Conditions
- Overactive Bladder
- Being tested
- Solifenacin
- Keywords
- OABSS, IPSS, PPBC, 3-day micturition diary, Solifenacin
- 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.
SolifenacinDrug
Also called Vesicare
oral
What is being measured
The primary outcome is the main question the study is designed to answer.
OABSS
Measured: Weeks 0, 4 and 12
Secondary outcomes (3)
International Prostate Symptom Score (IPSS)
Measured: Weeks 0, 4 and 12
Quality of Life (QOL) Score
Measured: Weeks 0, 4 and 12
Patient Perception of Bladder Condition (PPBC)
Measured: Weeks 0, 4 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startSep 2009
- Primary completionJan 2011
- Study completionJan 2011
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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Indonesia Inc.
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122563
- Sponsor's protocol ID
- EQL-CRU.005-2009
- Acronym
- RESORT-2
- Status last verified
- Jan 2011
- First submitted
- 11 May 2010
- Last updated
- 13 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 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 in Indonesia - Part 2: Responsiveness
- ClinicalTrials.gov ID
- NCT01122563
- Acronym / sponsor ID
- RESORT-2 / EQL-CRU.005-2009
- Conditions
- Overactive Bladder
- Keywords
- OABSS, IPSS, PPBC, 3-day micturition diary, Solifenacin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Indonesia Inc.
- Study start
- Sep 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 13 May 2010 (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.
This study is to evaluate change of overactive bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
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 3 urgency episode in last 3 days
- Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:
Key exclusion criteria (7 listed)
- Significant stress incontinence or mixed stress/urge incontinence
- Subject with indwelling catheters or practicing intermittent self-catheterization
- Symptomatic urinary tract infection, chronic inflammation
- Diabetic neuropathy
- Subjects who are prohibited from taking solifenacin as contraindications
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 |
|---|---|---|
| SolifenacinAlso: Vesicareoral | Drug | – |
Primary outcome
OABSS
Time frame: Weeks 0, 4 and 12
3 secondary outcomes
International Prostate Symptom Score (IPSS)
Time frame: Weeks 0, 4 and 12
Quality of Life (QOL) Score
Time frame: Weeks 0, 4 and 12
Patient Perception of Bladder Condition (PPBC)
Time frame: Weeks 0, 4 and 12
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 13 Jan 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 Indonesia
3 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 3 sites in Indonesia.
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 7 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 13 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. 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 0, 4 and 12). 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 13 Jan 2011; AzTrials last refreshed its copy on 29 Oct 2026.