Reproducibility Study of OABSS and Its Response to Treatment

Study Overview
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Brief Summary
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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.

Official Title
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Overactive Bladder Symptom Scores (OABSS) Responsiveness Before and After Anticholinergic Treatment in Women With Overactive Bladder (OAB)

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Solifenacin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Solifenacin<br> | Drug: Solifenacin<br>* Oral<br>* Other names: Vesicare;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in OABSS scores from prior to treatment and after treatment |  | Prior to treatment and after treatment (up to 12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of change between OABSS scores and number of micturitions per day |  | Prior to treatment and after treatment (up to 12 weeks) | 
| Correlation of change between OABSS scores and number of incontinence episodes per day |  | Prior to treatment and after treatment (up to 12 weeks) | 
| Correlation of change between OABSS scores and number of urgency episodes per day |  | Prior to treatment and after treatment (up to 12 weeks) | 
| Correlation of change between OABSS scores and number of nocturia episodes per day |  | Prior to treatment and after treatment (up to 12 weeks) | 
| Correlation of change between OABSS scores and number of total voided volume per day |  | Prior to treatment and after treatment (up to 12 weeks) | 
| Correlation of change between OABSS scores and number of pads per day |  | Prior to treatment and after treatment (up to 12 weeks) | 
| Correlation of change between OABSS scores and total International Prostate Symptom Score (IPSS) score |  | Prior to treatment and after treatment (up to 12 weeks) | 
| Correlation of change between OABSS scores and IPSS Quality of Life (QoL) score |  | Prior to treatment and after treatment (up to 12 weeks) | 
| Correlation of change between OABSS scores and Patient Perception of Bladder Condition (PPBC) total score |  | Prior to treatment and after treatment (up to 12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solifenacin, Overactive bladder