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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:
ClinicalTrials.gov Identifier:
NCT01122563
First Posted: May 13, 2010
Last Update Posted: January 13, 2011
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.
Collaborator:
Astellas Pharma Indonesia Inc.
Information provided by:
Astellas Pharma Inc
  Purpose
This study is to evaluate change of overactive bladder symptom scores (OABSS) between, before and after solifenacin treatment to OAB subjects.

Condition Intervention
Overactive Bladder Drug: Solifenacin

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Reproducibility Study of OABSS and Its Response to Treatment in Indonesia - Part 2: Responsiveness

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • OABSS [ Time Frame: Weeks 0, 4 and 12 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 55
Study Start Date: September 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Solifenacin
    oral
    Other Name: Vesicare
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Symptomatic OAB patients having urgency episodes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01122563


Locations
Indonesia
Bandung, Indonesia
Jakarta, Indonesia
Surabaya, Indonesia
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Indonesia Inc.
Investigators
Study Chair: Use Central Contact Astellas Pharma Indonesia
  More Information

Responsible Party: Disclosure Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01122563     History of Changes
Other Study ID Numbers: EQL-CRU.005-2009
First Submitted: May 11, 2010
First Posted: May 13, 2010
Last Update Posted: January 13, 2011
Last Verified: January 2011

Keywords provided by Astellas Pharma Inc:
OABSS
IPSS
PPBC
3-day micturition diary
Solifenacin

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents