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Evaluation of Adherence to Solifenacin Treatment in Overactive Bladder Patients

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. Identifier: NCT00985387
Recruitment Status : Completed
First Posted : September 28, 2009
Last Update Posted : October 12, 2011
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc

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

Condition or disease Intervention/treatment
Urinary Bladder, Overactive Overactive Bladder Drug: Solifenacin

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Study Type : Observational
Actual Enrollment : 1215 participants
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
Study Start Date : August 2009
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Solifenacin treatment
Male and female OAB patients who were treated with solifenacin
Drug: Solifenacin
Other Names:
  • YM905
  • Vesicare

Primary Outcome Measures :
  1. percentage of patients who are maintaining solifenacin treatment [ Time Frame: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12 ]

Secondary Outcome Measures :
  1. percentage of patients who discontinued solifenacin treatment [ Time Frame: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12 ]
  2. percentage of patients who switched to other OAB medication [ Time Frame: Month 0, Month 1, Month 3, Month 6, Month 9 and Month 12 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
OAB patients who were treated with solifenacin

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

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 identifier (NCT number): NCT00985387

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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, 700-712
Daegu, Korea, Republic of, 700-721
Daegu, Korea, Republic of, 705-717
Daegu, Korea, Republic of, 705-718
Daejeon, Korea, Republic of, 301-721
Daejeon, Korea, Republic of, 302-718
Daejeon, Korea, Republic of, 302-799
Gangneung, Korea, Republic of, 201-711
Gumi-si, Korea, Republic of, 730-728
Gwangju, Korea, Republic of, 501-717
Gwangju, Korea, Republic of, 501-757
Gwangju, Korea, Republic of, 503-715
Gyongju, Korea, Republic of, 780-350
Hwasun, Korea, Republic of, 519-809
Iksan, Korea, Republic of, 570-160
Inchon, Korea, Republic of, 400-711
Inchon, Korea, Republic of, 405-760
Jeonju, Korea, Republic of, 561-712
Masan, Korea, Republic of, 630-522
Seongnam, Korea, Republic of, 463-707
Seoul, Korea, Republic of, 100-380
Seoul, Korea, Republic of, 110-744
Seoul, Korea, Republic of, 130-702
Seoul, Korea, Republic of, 133-792
Seoul, Korea, Republic of, 136-705
Seoul, Korea, Republic of, 137-701
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 139-711
Seoul, Korea, Republic of, 143-729
Seoul, Korea, Republic of, 158-710
Suwon, Korea, Republic of, 443-721
Ulsan, Korea, Republic of, 682-714
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Korea, Inc.
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Study Chair: Use Central Contact Astellas Pharma Inc
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Responsible Party: Astellas Pharma Inc Identifier: NCT00985387    
Other Study ID Numbers: SPK-1
First Posted: September 28, 2009    Key Record Dates
Last Update Posted: October 12, 2011
Last Verified: October 2011
Keywords provided by Astellas Pharma Inc:
Overactive bladder
persistency of the treatment
Additional relevant MeSH terms:
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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