Reproducibility Study of OABSS and Its Response to Treatment

Astellas Pharma Inc50 enrolled

Overview

The objective of this study is to evaluate change of Overactive Bladder (OAB) Symptom Score (OABSS) scores between before and after Solifenacin treatment to OAB patients and to evaluate correlation between change of OABSS scores and other measures for OAB symptoms.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Overactive Bladder

Interventions

SolifenacinDRUG

Oral

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * At screening visit (Week -2): * Symptoms of OAB ≥ 3 months * Number of urgency episodes in last 3 days ≥ 3 * Based on the 3-day micturition diary prior to Visit 1 (Week 0): * Number of micturition per day ≥ 8 * Number of urgency episodes in 3 days ≥ 3 Exclusion Criteria: * At screening visit (Week -2): * Stress is the predominant factor as determined by the investigator * Indwelling catheters or practicing intermittent self-catheterization * Symptomatic urinary tract infection, chronic inflammation * Treatment for OAB was started, quitted or changed in 4 weeks * Diabetic neuropathy * At Visit 1 (Week 0): * Patient who did not complete the 3-day micturition diary according to the instruction

Locations (1)

Site: 1

Bangkok, Bangkok, Thailand