Urinary Bladder, OveractiveNCT00985387
Evaluation of Adherence to Solifenacin Treatment in Overactive Bladder Patients
An observational study of Urinary Bladder, Overactive and Overactive Bladder, run by Astellas Pharma Inc at 41 sites in South Korea.
Trial summary
The purpose of the study is to assess patient's persistency in maintaining solifenacin treatment for overactive bladder. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urinary Bladder, Overactive, Overactive Bladder
- What is being tested?
- Solifenacin
- Type of treatment
- Pill or oral medicine
- How many people
- 1,215 participants
- Where
- 41 sitesSouth Korea
- Study dates
- Aug 2009to Aug 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: OAB patients who were treated with solifenacin
Who may be able to join
- Overactive bladder symptoms lasting for more than 3 months
- The question 3 score of the overactive bladder symptom score(OABSS)≥ 2 and the sum score of OABSS ≥ 3
- Symptoms of urinary urgency defined as a level of 1 to 2 in a 3-point Urgency Perception Scale (UPS)
Who cannot join
- Any condition that would contraindicate their usage of anticholinergic treatment, including: urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis
- Symptomatic acute urinary tract infection (UTI)
- Diagnosed or suspected of interstitial cystitis
- Treatment with anticholinergic drugs for over 3 months within 12 months prior to the study
- Pregnant or nursing women
- Treatment within the 14 days before the study or expected to initiate treatment during the study with any anticholinergic drugs other than solifenacin or treatment for overactive bladder with other drugs
- Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
South Korea41 sites
Study site
Bucheon-si, 420-717
Study site
Bucheon-si, 420-767
Study site
Busan, 602-702
Study site
Busan, 602-715
Study site
Busan, 602-739
Study site
Busan, 614-735
Study site
Chuncheon, 200-704
Study site
Daegu, 700-712
Study site
Daegu, 700-721
Study site
Daegu, 705-717
Study site
Daegu, 705-718
Study site
Daejeon, 301-721
Study site
Daejeon, 302-718
Study site
Daejeon, 302-799
Study site
Gangneung, 201-711
Study site
Gumi, 730-728
Study site
Gwangju, 501-717
Study site
Gwangju, 501-757
Study site
Gwangju, 503-715
Study site
Gyongju, 780-350
Study site
Hwasun, 519-809
Study site
Iksan, 570-160
Study site
Inchon, 400-711
Study site
Inchon, 405-760
Study site
Jeonju, 361-711
Study site
Jeonju, 380-704
Study site
Jeonju, 561-712
Study site
Masan, 630-522
Study site
Seongnam, 463-707
Study site
Seoul, 100-380
Study site
Seoul, 110-744
Study site
Seoul, 130-702
Study site
Seoul, 133-792
Study site
Seoul, 136-705
Study site
Seoul, 137-701
Study site
Seoul, 138-736
Study site
Seoul, 139-711
Study site
Seoul, 143-729
Study site
Seoul, 158-710
Study site
Suwon, 443-721
Study site
Ulsan, 682-714
About this study
Official title: Persistence of Solifenacin Treatment in Overactive Bladder Patients in Real Life Practice: A 12-month, Prospective, Multicenter, Open-label, Observational Study
The purpose of the study is to assess patient's persistency in maintaining solifenacin treatment for overactive bladder.
- Conditions
- Urinary Bladder, Overactive, Overactive Bladder
- Being tested
- Solifenacin
- Keywords
- Solifenacin, Overactive bladder, persistency of the treatment, Vesicare
- 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 YM905, Vesicare
oral
| Study group | Role | What they receive |
|---|---|---|
| Solifenacin treatment | Male and female OAB patients who were treated with solifenacin Receives: Drug: Solifenacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients who are maintaining solifenacin treatment
Measured: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12
Secondary outcomes (2)
percentage of patients who discontinued solifenacin treatment
Measured: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12
percentage of patients who switched to other OAB medication
Measured: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2011
- Study completionAug 2011
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.
- 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
- Prospective
- Enrolment
- 1,215 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, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985387
- Sponsor's protocol ID
- SPK-1
- Status last verified
- Oct 2011
- First submitted
- 25 Sep 2009
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistence of Solifenacin Treatment in Overactive Bladder Patients in Real Life Practice: A 12-month, Prospective, Multicenter, Open-label, Observational Study
- ClinicalTrials.gov ID
- NCT00985387
- Acronym / sponsor ID
- SPK-1
- Conditions
- Urinary Bladder, Overactive, Overactive Bladder
- Keywords
- Solifenacin, Overactive bladder, persistency of the treatment, Vesicare
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,215 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Korea, Inc.
- Study start
- Aug 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 28 Sep 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 the study is to assess patient's persistency in maintaining solifenacin treatment for overactive bladder.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solifenacin treatment | – | Drug: SolifenacinMale and female OAB patients who were treated with solifenacin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- OAB patients who were treated with solifenacin
Key inclusion criteria (3 listed)
- Overactive bladder symptoms lasting for more than 3 months
- The question 3 score of the overactive bladder symptom score(OABSS)≥ 2 and the sum score of OABSS ≥ 3
- Symptoms of urinary urgency defined as a level of 1 to 2 in a 3-point Urgency Perception Scale (UPS)
Key exclusion criteria (7 listed)
- Any condition that would contraindicate their usage of anticholinergic treatment, including: urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis
- Symptomatic acute urinary tract infection (UTI)
- Diagnosed or suspected of interstitial cystitis
- Treatment with anticholinergic drugs for over 3 months within 12 months prior to the study
- Pregnant or nursing women
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: YM905, Vesicareoral | Drug | Solifenacin treatment |
Primary outcome
percentage of patients who are maintaining solifenacin treatment
Time frame: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12
2 secondary outcomes
percentage of patients who discontinued solifenacin treatment
Time frame: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12
percentage of patients who switched to other OAB medication
Time frame: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 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 12 Oct 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 Inc
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder, Overactive and Overactive Bladder, run by Astellas Pharma Inc at 41 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 3 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 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 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.
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?
percentage of patients who are maintaining solifenacin treatment (time frame: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 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 12 Oct 2011.