Overactive Bladder
Conditions
Keywords
OABSS, IPSS, PPBC, 3-day micturition diary, Solifenacin
Brief summary
This study is to evaluate change of overactive bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.
Interventions
DRUGSolifenacin
oral
Sponsors
Astellas Pharma Indonesia Inc.
Astellas Pharma Inc
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptoms OAB for 3 months or longer * At least 3 urgency episode in last 3 days * Symptoms of OAB as verified by the screening 3-day bladder diary, defined by: * Number of micturition ≥8 times/day * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OABSS | Weeks 0, 4 and 12 |
Secondary
| Measure | Time frame |
|---|---|
| International Prostate Symptom Score (IPSS) | Weeks 0, 4 and 12 |
| Quality of Life (QOL) Score | Weeks 0, 4 and 12 |
| Patient Perception of Bladder Condition (PPBC) | Weeks 0, 4 and 12 |
Countries
Indonesia
Outcome results
None listed