A Study to Evaluate Response of Overactive Bladder Symptom Score (OABSS) to Treatment

Completed

• Conditions: Overactive Bladder

• Registration Number: NCT01122563
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

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: 2011-01
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Last Update Submitted: 2011-01-11
• Last Update Posted: 2011-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Symptoms OAB for 3 months or longer

• At least 3 urgency episode in last 3 days

• Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:

  • Number of micturition ≥8 times/day
  • 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OABSS	Weeks 0, 4 and 12

Secondary Outcome Measures

Name	Time	Method
Quality of Life (QOL) Score	Weeks 0, 4 and 12
Patient Perception of Bladder Condition (PPBC)	Weeks 0, 4 and 12
International Prostate Symptom Score (IPSS)	Weeks 0, 4 and 12