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

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma Korea, Inc.
• Treatments: Solifenacin Succinate

Criteria

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