Reproducibility Study of Overactive Bladder Symptom Score [OABSS]

Completed

• Conditions: Overactive Bladder

• Registration Number: NCT01122550
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-05-11
• Study First Submitted QC: 2010-05-11
• Study First Posted: 2010-05-13
• Status Verified: 2010-08
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Last Update Submitted: 2010-08-23
• Last Update Posted: 2010-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OABSS	Weeks 0 and 2

Secondary Outcome Measures

Name	Time	Method
International Prostate Symptom Score (IPSS)	Weeks 0 and 2
Quality of Life (QOL) score	Weeks 0 and 2
Patient Perception of Bladder Condition (PPBC)	Weeks 0 and 2