NCT00901251

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2009

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2009

Completed
Last Updated

March 15, 2011

Status Verified

March 1, 2011

Enrollment Period

4 months

First QC Date

May 11, 2009

Last Update Submit

March 13, 2011

Conditions

Overactive Bladder

Keywords

OABSS

Outcome Measures

Primary Outcomes (1)

  • OABSS

    Weeks of 0 and 2

Secondary Outcomes (1)

  • 3-day micturition diary

    2 times in 2-week interval

Study Arms (1)

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Symptomatic OAB patients having urgency episodes

You may qualify if:

  • 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

You may not qualify if:

  • Indwelling catheters or practicing intermittent self-catheterization
  • Symptomatic urinary tract infection, chronic inflammation
  • Diabetic neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Beijing, China

Location

Unknown Facility

Chongqing, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Shenyang, China

Location

Unknown Facility

Wuhan, China

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Use Central Contact

    Astellas Pharma China, Inc.

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 11, 2009

First Posted

May 13, 2009

Study Start

January 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

March 15, 2011

Record last verified: 2011-03

Locations

CN(5)