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
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Disclosure Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT01122563     History of Changes
Other Study ID Numbers: EQL-CRU.005-2009
Study First Received: May 11, 2010
Last Updated: January 11, 2011
Health Authority: Indonesia: National Agency of Drug and Food Control

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
Urological Manifestations
Signs and Symptoms
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 23, 2014