Over Active BladderPhase 4RESORT-2NCT01318837
A Study to Evaluate Response of Over Active Bladder Symptom Score to Solifenacin Treatment
A Phase 4 study testing solifenacin in people with Over Active Bladder, run by Astellas Pharma Inc at 2 sites in South Korea.
Trial summary
This study is to evaluate change of over active 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
- Over Active Bladder
- What is being tested?
- solifenacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Apr 2010to Sep 2011
- Phase
- Phase 4
- 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
Who may be able to join
- Symptoms of 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:
- a. Number of micturition ≥8 times/day
- b. 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
- Diabetic neuropathy
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Reproducibility Study of OABSS and Its Response to Solifenacin Treatment (RESORT) and Validity in Korean Populations; Part 2: Responsiveness and Validity
This study is to evaluate change of over active bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.
- Conditions
- Over Active Bladder
- Being tested
- solifenacin
- Keywords
- OABSS, IPSS, PPBC, Solifenacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solifenacinDrug
Also called Vesicare
oral
| Study group | Role | What they receive |
|---|---|---|
| sofilenacin group | Experimental | Not described Receives: Drug: solifenacin |
| control group | No intervention | age and sex matched patients without OAB symptom who will answer demographic questionaire and OABSS once |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline to week 4 in Over-Active Bladder Symptom Score (OABSS)
Measured: week 0 (baseline) and week 4
Changes from baseline to week 12 in OABSS
Measured: week 0 (baseline) and week 12
Secondary outcomes (6)
Changes from baseline in International Prostate Symptom Score (IPSS) at week 4
Measured: week 0 (baseline) and week 4
Changes from baseline in IPSS at week 12
Measured: week 0 (baseline) and week 12
Changes from baseline in Quality of Life (QoL) Score at week 4
Measured: week 0 (baseline) and week 4
Changes from baseline in QoL Score at week 12
Measured: week 0 (baseline) and week 12
Changes from baseline in Patient Perception of Bladder Condition (PPBC) at week 4
Measured: week 0 (baseline) and week 4
Changes from baseline in PPBC at week 12
Measured: week 0 (baseline) and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startApr 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Over Active 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
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Korea, Inc.
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Principal investigator, Bundang Seoul National University Hospital, Seong Jin Jeong, MD.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318837
- Sponsor's protocol ID
- OABSSVSK-002
- Acronym
- RESORT-2
- Status last verified
- Jul 2014
- First submitted
- 17 Mar 2011
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Jeong SJ, Homma Y, Oh SJ. Reproducibility study of Overactive Bladder Symptom Score questionnaire and its response to treatment (RESORT) in Korean population with overactive bladder symptoms. Qual Life Res. 2014 Feb;23(1):285-92. doi: 10.1007/s11136-013-0440-7. Epub 2013 May 29.
PubMed 23715806
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility Study of OABSS and Its Response to Solifenacin Treatment (RESORT) and Validity in Korean Populations; Part 2: Responsiveness and Validity
- ClinicalTrials.gov ID
- NCT01318837
- Acronym / sponsor ID
- RESORT-2 / OABSSVSK-002
- Conditions
- Over Active Bladder
- Keywords
- OABSS, IPSS, PPBC, Solifenacin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Korea, Inc.
- Study start
- Apr 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 21 Mar 2011 (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 over active bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sofilenacin group | Experimental | Drug: solifenacin |
| control group | No intervention | –age and sex matched patients without OAB symptom who will answer demographic questionaire and OABSS once |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Symptoms of 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 (8 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 | sofilenacin group |
Primary outcome
Changes from baseline to week 4 in Over-Active Bladder Symptom Score (OABSS)
Time frame: week 0 (baseline) and week 4
Changes from baseline to week 12 in OABSS
Time frame: week 0 (baseline) and week 12
6 secondary outcomes
Changes from baseline in International Prostate Symptom Score (IPSS) at week 4
Time frame: week 0 (baseline) and week 4
Changes from baseline in IPSS at week 12
Time frame: week 0 (baseline) and week 12
Changes from baseline in Quality of Life (QoL) Score at week 4
Time frame: week 0 (baseline) and week 4
Changes from baseline in QoL Score at week 12
Time frame: week 0 (baseline) and week 12
Changes from baseline in Patient Perception of Bladder Condition (PPBC) at week 4
Time frame: week 0 (baseline) and week 4
Changes from baseline in PPBC at week 12
Time frame: week 0 (baseline) and week 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 10 Jul 2014.
- Background: PubMed 23715806Jeong SJ, Homma Y, Oh SJ. Reproducibility study of Overactive Bladder Symptom Score questionnaire and its response to treatment (RESORT) in Korean population with overactive bladder symptoms. Qual Life Res. 2014 Feb;23(1):285-92. doi: 10.1007/s11136-013-0440-7. Epub 2013 May 29.
Related trials for Over Active Bladder
Enrolling by invitationObservational study
Autologous Platelet Concentrate Bladder Injection for Refractory Overactive Bladder
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Recruiting
Electroacupuncture as a Treatment for Refractory Overactive Bladder
Over Active Bladder, Urinary Incontinence (UI)
Not yet recruiting
Stimulating Percutaneous Array for Urinary Reflex Control (SPARC)
Over Active Bladder
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 principal investigator
Bundang Seoul National University Hospital, Seong Jin Jeong, MD.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing solifenacin in people with Over Active Bladder, run by Astellas Pharma Inc at 2 sites in South Korea.
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 8 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 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes from baseline to week 4 in Over-Active Bladder Symptom Score (OABSS) (time frame: week 0 (baseline) and week 4). 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?
On the ClinicalTrials.gov record for NCT01318837, which also lists 1 linked publication.
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 10 Jul 2014.