Overview

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