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
• 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

• Overactive Bladder
• Urinary Bladder, Overactive

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