A Study to Evaluate Response of Over Active Bladder Symptom Score to Solifenacin Treatment
NCT ID: NCT01318837
Last Updated: 2014-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2010-04-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
NONE
Study Groups
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sofilenacin group
solifenacin
oral
control group
age and sex matched patients without OAB symptom who will answer demographic questionaire and OABSS once
No interventions assigned to this group
Interventions
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solifenacin
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Astellas Pharma Korea, Inc.
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: PRINCIPAL_INVESTIGATOR
Bundang Seoul National University Hospital, Seong Jin Jeong, MD.
Locations
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Seoul, , South Korea
Sungnam, , South Korea
Countries
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References
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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.
Other Identifiers
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OABSSVSK-002
Identifier Type: -
Identifier Source: org_study_id
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