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NCT00901251 Clinical Trial

Reproducibility Study of Over Active Bladder Symptom Score [OABSS]

Overactive Bladder Clinical Trial

— RESORT  

Official title:
Reproducibility Study of OABSS and Its Response to Treatment - Part 1: Reproducibility -

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00901251
Other study ID # VESOABCN02
Secondary ID
Status Completed
Phase N/A
First received May 11, 2009
Last updated March 13, 2011
Start date January 2009
Est. completion date May 2009

Study information
Verified date March 2011
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the reproducibility of over active bladder symptom score (OABSS) in Asian countries.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date May 2009
Est. primary completion date May 2009
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 the screening 3-day bladder diary, defined by:

- Number of micturition =8 times/day

- Number of urgency episode in 3 days =1

Exclusion Criteria:

- Indwelling catheters or practicing intermittent self-catheterization

- Symptomatic urinary tract infection, chronic inflammation

- Diabetic neuropathy

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Astellas Pharma Inc Astellas Pharma China, Inc.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary OABSS Weeks of 0 and 2 No
Secondary 3-day micturition diary 2 times in 2-week interval No
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