Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Astellas Pharma Korea, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is to evaluate change of over active bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sofilenacin group | Experimental |
| |
| control group | No Intervention | age and sex matched patients without OAB symptom who will answer demographic questionaire and OABSS once |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| solifenacin | Drug | oral |
|
|
| 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 |
| 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 | |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Bundang Seoul National University Hospital, Seong Jin Jeong, MD. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul | South Korea | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23715806 | Background | Jeong SJ, Homma Y, Oh SJ. Reproducibility study of Overactive Bladder Symptom Score questionnaire and its response to treatment (RESORT) in Korean population with overactive bladder symptoms. Qual Life Res. 2014 Feb;23(1):285-92. doi: 10.1007/s11136-013-0440-7. Epub 2013 May 29. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Sungnam |
| South Korea |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |