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NCT01122550 Clinical Trial

Reproducibility Study of Overactive Bladder Symptom Score [OABSS]

Overactive Bladder Clinical Trial

— RESORT-1  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01122550
Other study ID # EQL-CRU.004-2009
Secondary ID
Status Completed
Phase N/A
First received May 11, 2010
Last updated August 23, 2010
Start date September 2009
Est. completion date August 2010

Study information
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

Clinical Trial Summary

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.

Recruitment information / eligibility
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

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 Indonesia Inc.

Country where clinical trial is conducted

Indonesia, 

Outcome
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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Completed NCT01122563 - A Study to Evaluate Response of Overactive Bladder Symptom Score (OABSS) to Treatment N/A