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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Indonesia Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01122563
First received: May 11, 2010
Last updated: January 11, 2011
Last verified: January 2011
History of Changes

May 11, 2010
January 11, 2011
September 2009
January 2011   (final data collection date for primary outcome measure)
OABSS [ Time Frame: Weeks 0, 4 and 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01122563 on ClinicalTrials.gov Archive Site
  • International Prostate Symptom Score (IPSS) [ Time Frame: Weeks 0, 4 and 12 ] [ Designated as safety issue: No ]
  • Quality of Life (QOL) Score [ Time Frame: Weeks 0, 4 and 12 ] [ Designated as safety issue: No ]
  • Patient Perception of Bladder Condition (PPBC) [ Time Frame: Weeks 0, 4 and 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Symptomatic OAB patients having urgency episodes
Overactive Bladder
Drug: Solifenacin
oral
Other Name: Vesicare
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Indonesia
 
NCT01122563
EQL-CRU.005-2009
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP