A Study to Evaluate Response of Over Active Bladder Symptom Score to Solifenacin Treatment

NCT ID: NCT01318837

Last Updated: 2014-07-10

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

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-09-30

Brief Summary

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This study is to evaluate change of over active bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.

Detailed Description

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Conditions

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Over Active Bladder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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sofilenacin group

Group Type EXPERIMENTAL

solifenacin

Intervention Type DRUG

oral

control group

age and sex matched patients without OAB symptom who will answer demographic questionaire and OABSS once

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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solifenacin

oral

Intervention Type DRUG

Other Intervention Names

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Vesicare

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 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: PRINCIPAL_INVESTIGATOR

Bundang Seoul National University Hospital, Seong Jin Jeong, MD.

Locations

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Seoul, , South Korea

Site Status

Sungnam, , South Korea

Site Status

Countries

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South Korea

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.

Reference Type BACKGROUND
PMID: 23715806 (View on PubMed)

Other Identifiers

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OABSSVSK-002

Identifier Type: -

Identifier Source: org_study_id

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