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

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

Official Title
-----------------
Reproducibility Study of OABSS and Its Response to Solifenacin Treatment (RESORT) and Validity in Korean Populations; Part 2: Responsiveness and Validity

Conditions
-----------------
Over Active Bladder

Intervention / Treatment
-----------------
* Drug: solifenacin


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sofilenacin group<br> | Drug: solifenacin<br>* oral<br>* Other names: Vesicare;|
| No Intervention: control group<br>age and sex matched patients without OAB symptom who will answer demographic questionaire and OABSS once | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline to week 4 in Over-Active Bladder Symptom Score (OABSS) |  | week 0 (baseline) and week 4 | 
| Changes from baseline to week 12 in OABSS |  | week 0 (baseline) and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in International Prostate Symptom Score (IPSS) at week 4 |  | week 0 (baseline) and week 4 | 
| Changes from baseline in IPSS at week 12 |  | week 0 (baseline) and week 12 | 
| Changes from baseline in Quality of Life (QoL) Score at week 4 |  | week 0 (baseline) and week 4 | 
| Changes from baseline in QoL Score at week 12 |  | week 0 (baseline) and week 12 | 
| Changes from baseline in Patient Perception of Bladder Condition (PPBC) at week 4 |  | week 0 (baseline) and week 4 | 
| Changes from baseline in PPBC at week 12 |  | week 0 (baseline) and week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OABSS, IPSS, PPBC, Solifenacin