Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin

Study Overview
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Brief Summary
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A prospective, multicenter, observation study to estimate the dry mouth in OAB patients with solifenacin

Detailed Description
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To estimate the dry mouth and their impact on the efficacy of the drug in overactive bladder patients with solifenacin

Official Title
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A Prospective, Multicenter, Observation Study to Estimate the Dry Mouth in OAB Patients With Solifenacin

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: solifenacin 5mg, 10mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) male or female patients with 20 years of age or older 2) clinical history of OAB for at least 3 months prior to visit 2 3) more than 3 in total score and 2 in Q 3 index from OABSS questionnaire Exclusion Criteria: 1) In clinical trial, female with pregnant, intent to become pregnant or breast-feeding 2)post-voided residual urine volume > 150ml 3) a history of catheterization due to acute urinary retention 4) a history of pelvic surgery within 6 months 5) 6) 7) a history of neurovascular disease such as Parkinson's disease, cerebral vascular disease, spinal injury or multiple sclerosis 8)patients with indwelling catheter or intermittent catheterization 9) active or recurrent (>3 episodes per year) urinary tract infection 10) the use of the following medication at least 2 weeks anticholinergics Tricyclic antidepressants,anti-epilepsy drug, anti-Parkinson's disease drug, anti-arrythmia drug type I Chlorpromazine, Thioridazine, Piperazine MAO inhibitor 11) Patient is currently taking or has taken within the past 4 weeks alpha-blocker for the treatment of benign prostatic hypertrophy 12) Patient is currently taking or has taken within the past 8 weeks 5ARI or estrogen medication 13) Patient is currently using or has used medications with known activities as inhibitors or inducers of cytochrome P4503A4 (CYP3A4)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| dry mouth patients with solifenacin<br>dry mouth patients with solifenacin 5mg, 10mg | Drug: solifenacin 5mg, 10mg<br>* solifenacin 5mg, 10mg<br>* Other names: Vesicare;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of the total score in Xerostomia inventory XI from baseline | 11-item summated rating scale. Respondents were asked to choose one of five responses ('never', scoring 1 'very often', 5) total best and worst values: 11 and 49 | after 8 weeks of treatment from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global response assessment | range, 1 7 | after 8 weeks of treatment from baseline | 
| The changes of the total score in overactive bladder symptom score (OABSS) from baseline | total best and worst values: 0 and 15 | after 8 weeks treatment from baseline | 
| Visual Analog Scale (VAS) of dry mouth | The changes of the Visual Analog Scale (VAS) of dry mouth from baseline (range, 0 10) | after 8 weeks treatment from baseline |