Reproducibility Study of Overactive Bladder Symptom Score [OABSS]

NCT ID: NCT01122550

Last Updated: 2010-08-24

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

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-08-31

Brief Summary

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The purpose of this study is to evaluate its reproducibility of overactive bladder symptom score (OABSS) and to evaluate its correlation to other measures of OAB symptoms.

Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Symptoms OAB for 3 months or longer
* At least 1 urgency episode in last 3 days
* Symptoms of OAB as verified by 3-day micturition diary prior to Visit 1, defined by:

* Number of micturition per day ≥8
* Number of urgency episodes in 3 days ≥1

Exclusion Criteria

* Significant stress incontinence or mixed stress/urge incontinence
* Subjects with indwelling catheters or practicing intermittent self-catheterization
* Symptomatic urinary tract infection, chronic inflammation
* Diabetic neuropathy
* Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks
* Participation in any clinical trial in 30 days
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Indonesia Inc.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Astellas Pharma, Inc

Principal Investigators

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Use Central Contact

Role: STUDY_CHAIR

Astellas Pharma Indonesia

Locations

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Bandung, , Indonesia

Site Status

Jakarta, , Indonesia

Site Status

Surabaya, , Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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EQL-CRU.004-2009

Identifier Type: -

Identifier Source: org_study_id

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