A Study to Evaluate Response of Overactive Bladder Symptom Score (OABSS) to Treatment

Overactive Bladder Clinical Trial

— RESORT-2  

Official title:

Reproducibility Study of OABSS and Its Response to Treatment in Indonesia - Part 2: Responsiveness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01122563
• Other study ID #: EQL-CRU.005-2009
• Status: Completed
• Phase: N/A
• First received: May 11, 2010
• Last updated: January 11, 2011
• Start date: September 2009
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• 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

This study is to evaluate change of overactive bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Symptoms OAB for 3 months or longer

• At least 3 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 episodes in 3 days =3

Exclusion Criteria:

• Significant stress incontinence or mixed stress/urge incontinence

• Subject with indwelling catheters or practicing intermittent self-catheterization

• Symptomatic urinary tract infection, chronic inflammation

• Diabetic neuropathy

• Subjects who are prohibited from taking solifenacin as contraindications

• Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks

• Participation in any clinical trial in 30 days except for Part-1 of RESORT

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Solifenacin
oral

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, 4 and 12	No
Secondary	International Prostate Symptom Score (IPSS)		Weeks 0, 4 and 12	No
Secondary	Quality of Life (QOL) Score		Weeks 0, 4 and 12	No
Secondary	Patient Perception of Bladder Condition (PPBC)		Weeks 0, 4 and 12	No