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Evaluation of Adherence to Solifenacin Treatment in Overactive Bladder Patients

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00985387
First received: September 25, 2009
Last updated: October 11, 2011
Last verified: October 2011
History of Changes
  Purpose

The purpose of the study is to assess patient's persistency in maintaining solifenacin treatment for overactive bladder.


Condition Intervention
Urinary Bladder, Overactive
Overactive Bladder
 Drug: Solifenacin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Persistence of Solifenacin Treatment in Overactive Bladder Patients in Real Life Practice: A 12-month, Prospective, Multicenter, Open-label, Observational Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • percentage of patients who are maintaining solifenacin treatment [ Time Frame: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • percentage of patients who discontinued solifenacin treatment [ Time Frame: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12 ] [ Designated as safety issue: No ]
  • percentage of patients who switched to other OAB medication [ Time Frame: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12 ] [ Designated as safety issue: No ]

Enrollment: 1215
Study Start Date: August 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Solifenacin treatment
Male and female OAB patients who were treated with solifenacin
 Drug: Solifenacin
oral
Other Names:
  • YM905
  • Vesicare

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

OAB patients who were treated with solifenacin

Criteria

Inclusion Criteria:

  • Overactive bladder symptoms lasting for more than 3 months
  • The question 3 score of the overactive bladder symptom score(OABSS)≥ 2 and the sum score of OABSS ≥ 3
  • Symptoms of urinary urgency defined as a level of 1 to 2 in a 3-point Urgency Perception Scale (UPS)

Exclusion Criteria:

  • Any condition that would contraindicate their usage of anticholinergic treatment, including: urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis
  • Symptomatic acute urinary tract infection (UTI)
  • Diagnosed or suspected of interstitial cystitis
  • Treatment with anticholinergic drugs for over 3 months within 12 months prior to the study
  • Pregnant or nursing women
  • Treatment within the 14 days before the study or expected to initiate treatment during the study with any anticholinergic drugs other than solifenacin or treatment for overactive bladder with other drugs
  • Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985387

Locations
Korea, Republic of
Bucheon, Korea, Republic of, 420-717
Bucheon, Korea, Republic of, 420-767
Busan, Korea, Republic of, 602-702
Busan, Korea, Republic of, 602-715
Busan, Korea, Republic of, 602-739
Busan, Korea, Republic of, 614-735
Chonju, Korea, Republic of, 361-711
Chonju, Korea, Republic of, 380-704
Chuncheon, Korea, Republic of, 200-704
Daegu, Korea, Republic of, 700-721
Daegu, Korea, Republic of, 700-712
Daegu, Korea, Republic of, 705-718
Daegu, Korea, Republic of, 705-717
Daejeon, Korea, Republic of, 302-718
Daejeon, Korea, Republic of, 302-799
Daejeon, Korea, Republic of, 301-721
Gangneung, Korea, Republic of, 201-711
Gumi-si, Korea, Republic of, 730-728
Gwangju, Korea, Republic of, 503-715
Gwangju, Korea, Republic of, 501-757
Gwangju, Korea, Republic of, 501-717
Gyongju, Korea, Republic of, 780-350
Hwasun, Korea, Republic of, 519-809
Iksan, Korea, Republic of, 570-160
Inchon, Korea, Republic of, 405-760
Inchon, Korea, Republic of, 400-711
Jeonju, Korea, Republic of, 561-712
Masan, Korea, Republic of, 630-522
Seongnam, Korea, Republic of, 463-707
Seoul, Korea, Republic of, 143-729
Seoul, Korea, Republic of, 130-702
Seoul, Korea, Republic of, 136-705
Seoul, Korea, Republic of, 137-701
Seoul, Korea, Republic of, 100-380
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 139-711
Seoul, Korea, Republic of, 158-710
Seoul, Korea, Republic of, 133-792
Suwon, Korea, Republic of, 443-721
Ulsan, Korea, Republic of, 682-714
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Korea, Inc.
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00985387     History of Changes
Other Study ID Numbers: SPK-1
Study First Received: September 25, 2009
Last Updated: October 11, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Solifenacin
Overactive bladder
persistency of the treatment
Vesicare

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 May 16, 2013