Overactive Bladder Clinical Trial
— RESORT-1Official title:
Reproducibility Study of OABSS and Its Response to Treatment in Indonesia - Part 1: Reproducibility -
Verified date | August 2010 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | Indonesia: National Agency of Drug and Food Control |
Study type | Observational |
The purpose of this study is to evaluate its reproducibility of overactive bladder symptom score (OABSS) and to evaluate its correlation to other measures of OAB symptoms.
Status | Completed |
Enrollment | 50 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Symptoms OAB for 3 months or longer - At least 1 urgency episode in last 3 days - Symptoms of OAB as verified by 3-day micturition diary prior to Visit 1, defined by: - Number of micturition per day =8 - Number of urgency episodes in 3 days =1 Exclusion Criteria: - Significant stress incontinence or mixed stress/urge incontinence - Subjects with indwelling catheters or practicing intermittent self-catheterization - Symptomatic urinary tract infection, chronic inflammation - Diabetic neuropathy - Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks - Participation in any clinical trial in 30 days |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Inc | Astellas Pharma Indonesia Inc. |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | OABSS | Weeks 0 and 2 | No | |
Secondary | International Prostate Symptom Score (IPSS) | Weeks 0 and 2 | No | |
Secondary | Quality of Life (QOL) score | Weeks 0 and 2 | No | |
Secondary | Patient Perception of Bladder Condition (PPBC) | Weeks 0 and 2 | No |
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