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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01122563
Recruitment Status : Completed
First Posted : May 13, 2010
Last Update Posted : January 13, 2011
Astellas Pharma Indonesia Inc.
Information provided by:
Astellas Pharma Inc

May 11, 2010
May 13, 2010
January 13, 2011
September 2009
January 2011   (Final data collection date for primary outcome measure)
OABSS [ Time Frame: Weeks 0, 4 and 12 ]
Same as current
Complete list of historical versions of study NCT01122563 on Archive Site
  • International Prostate Symptom Score (IPSS) [ Time Frame: Weeks 0, 4 and 12 ]
  • Quality of Life (QOL) Score [ Time Frame: Weeks 0, 4 and 12 ]
  • Patient Perception of Bladder Condition (PPBC) [ Time Frame: Weeks 0, 4 and 12 ]
Same as current
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A Study to Evaluate Response of Overactive Bladder Symptom Score (OABSS) to Treatment
Reproducibility Study of OABSS and Its Response to Treatment in Indonesia - Part 2: Responsiveness
This study is to evaluate change of overactive bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.
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Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Symptomatic OAB patients having urgency episodes
Overactive Bladder
Drug: Solifenacin
Other Name: Vesicare
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2011
January 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Disclosure Director, Astellas Pharma, Inc
Astellas Pharma Inc
Astellas Pharma Indonesia Inc.
Study Chair: Use Central Contact Astellas Pharma Indonesia
Astellas Pharma Inc
January 2011