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Clinical Trials/NCT00901251
NCT00901251CompletedNot Applicable

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

Astellas Pharma Inc0 sites50 target enrollmentStarted: January 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Primary Endpoint
OABSS

Study Overview

Brief Summary

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

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

OABSS

Time Frame: Weeks of 0 and 2

Secondary Outcomes

  • 3-day micturition diary(2 times in 2-week interval)

Investigators

Sponsor Class
Industry

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