Status:
COMPLETED
Evaluation of Adherence to Solifenacin Treatment in Overactive Bladder Patients
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma Korea, Inc.
Conditions:
Urinary Bladder, Overactive
Overactive Bladder
Eligibility:
All Genders
18-80 years
Brief Summary
The purpose of the study is to assess patient's persistency in maintaining solifenacin treatment for overactive bladder.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
1215 Patients enrolled
Trial Details
Trial ID
NCT00985387
Start Date
August 1 2009
End Date
August 1 2011
Last Update
October 12 2011
Active Locations (41)
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1
Bucheon-si, South Korea, 420-717
2
Bucheon-si, South Korea, 420-767
3
Busan, South Korea, 602-702
4
Busan, South Korea, 602-715