Evaluation of Adherence to Solifenacin Treatment in Overactive Bladder Patients

NCT ID: NCT00985387

Last Updated: 2011-10-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

1215 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-08-31

Brief Summary

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The purpose of the study is to assess patient's persistency in maintaining solifenacin treatment for overactive bladder.

Detailed Description

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Conditions

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Urinary Bladder, Overactive Overactive Bladder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Solifenacin treatment

Male and female OAB patients who were treated with solifenacin

Solifenacin

Intervention Type DRUG

oral

Interventions

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Solifenacin

oral

Intervention Type DRUG

Other Intervention Names

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YM905 Vesicare

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Korea, Inc.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Use Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

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Bucheon-si, , South Korea

Site Status

Bucheon-si, , South Korea

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Busan, , South Korea

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Busan, , South Korea

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Busan, , South Korea

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Busan, , South Korea

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Chuncheon, , South Korea

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Daegu, , South Korea

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Daegu, , South Korea

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Daegu, , South Korea

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Daegu, , South Korea

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Daejeon, , South Korea

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Daejeon, , South Korea

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Daejeon, , South Korea

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Gangneung, , South Korea

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Gumi, , South Korea

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Gwangju, , South Korea

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Gwangju, , South Korea

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Gwangju, , South Korea

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Gyongju, , South Korea

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Hwasun, , South Korea

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Iksan, , South Korea

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Inchon, , South Korea

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Inchon, , South Korea

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Jeonju, , South Korea

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Jeonju, , South Korea

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Jeonju, , South Korea

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Masan, , South Korea

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Seongnam, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Suwon, , South Korea

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Ulsan, , South Korea

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Countries

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South Korea

Other Identifiers

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SPK-1

Identifier Type: -

Identifier Source: org_study_id