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

Astellas Pharma Inc100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

100

Conditions

Over Active Bladder

Interventions

solifenacinDRUG

oral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Unnamed facility

Seoul, South Korea

Unnamed facility

Sungnam, South Korea

Outcomes

Primary Outcomes

Changes from baseline to week 4 in Over-Active Bladder Symptom Score (OABSS)

Time frame: week 0 (baseline) and week 4

Changes from baseline to week 12 in OABSS

Time frame: week 0 (baseline) and week 12

Secondary Outcomes

Changes from baseline in International Prostate Symptom Score (IPSS) at week 4

Time frame: week 0 (baseline) and week 4

Changes from baseline in IPSS at week 12

Time frame: week 0 (baseline) and week 12

Changes from baseline in Quality of Life (QoL) Score at week 4

Time frame: week 0 (baseline) and week 4

Changes from baseline in QoL Score at week 12

Time frame: week 0 (baseline) and week 12

Changes from baseline in Patient Perception of Bladder Condition (PPBC) at week 4

Time frame: week 0 (baseline) and week 4

Changes from baseline in PPBC at week 12

Time frame: week 0 (baseline) and week 12

Data from ClinicalTrials.gov

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