Over Active Bladder Clinical Trial
— RESORT-2Official title:
Reproducibility Study of OABSS and Its Response to Solifenacin Treatment (RESORT) and Validity in Korean Populations; Part 2: Responsiveness and Validity
Verified date | July 2014 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
This study is to evaluate change of over active bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.
Status | Completed |
Enrollment | 100 |
Est. completion date | September 2011 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Inc | Astellas Pharma Korea, Inc. |
Korea, Republic of,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes from baseline to week 4 in Over-Active Bladder Symptom Score (OABSS) | week 0 (baseline) and week 4 | No | |
Primary | Changes from baseline to week 12 in OABSS | week 0 (baseline) and week 12 | No | |
Secondary | Changes from baseline in International Prostate Symptom Score (IPSS) at week 4 | week 0 (baseline) and week 4 | No | |
Secondary | Changes from baseline in IPSS at week 12 | week 0 (baseline) and week 12 | No | |
Secondary | Changes from baseline in Quality of Life (QoL) Score at week 4 | week 0 (baseline) and week 4 | No | |
Secondary | Changes from baseline in QoL Score at week 12 | week 0 (baseline) and week 12 | No | |
Secondary | Changes from baseline in Patient Perception of Bladder Condition (PPBC) at week 4 | week 0 (baseline) and week 4 | No | |
Secondary | Changes from baseline in PPBC at week 12 | week 0 (baseline) and week 12 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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