RESORT-2: A Study to Evaluate Response of Overactive Bladder Symptom Score (OABSS) to Treatment

• Sponsor: Astellas Pharma Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01122563
• Collaborator: Astellas Pharma Indonesia Inc. (Industry)
• Enrollment: 55
• Locations: 3
• Duration (Months): 16
• Patients Per Site: 18.3
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder	Drug: Solifenacin

Study Design

• Study Type: Observational
• Actual Enrollment: 55 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Reproducibility Study of OABSS and Its Response to Treatment in Indonesia - Part 2: Responsiveness
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Outcome Measures

Primary Outcome Measures

1. OABSS [Weeks 0, 4 and 12]

Secondary Outcome Measures

1. International Prostate Symptom Score (IPSS) [Weeks 0, 4 and 12]

2. Quality of Life (QOL) Score [Weeks 0, 4 and 12]

3. Patient Perception of Bladder Condition (PPBC) [Weeks 0, 4 and 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Bandung		Indonesia
2		Jakarta		Indonesia
3		Surabaya		Indonesia

Sponsors and Collaborators

• Astellas Pharma Inc
• Astellas Pharma Indonesia Inc.

Investigators

• Study Chair: Use Central Contact, Astellas Pharma Indonesia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01122563
• Other Study ID Numbers: EQL-CRU.005-2009
• First Posted: May 13, 2010
• Last Update Posted: Jan 13, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: OABSS; IPSS; PPBC; 3-day micturition diary; Solifenacin
• Additional relevant MeSH terms: Urinary Bladder, Overactive; Solifenacin Succinate

Study Results

No Results Posted as of Jan 13, 2011