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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 25, 2014