Status:
COMPLETED
Interventions to Enhance Medication Persistence and Compliance in Patients With Overactive Bladder
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
Pfizer
Conditions:
Overactive Bladder
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Study Objectives: To explore the effectiveness of adjunctive intervention to enhance the medication compliance and persistence in patients with Overactive Bladder (OAB), thereby to improve treatment o...
Detailed Description
Treatment - Fesoterodine (Toviaz) 4 or 8mg Interventions (2 arms) \- Arm 1: No intervention Patients in this arm will not be given HEI in conjunction with pharmacotherapy (Toviaz) which was develop...
Eligibility Criteria
Inclusion
- Female aged ≥ 18 years with OAB symptoms for ≥ 3 months
- The sum score of the OABSS ≥ 3 with the score of the question no.3 (urgency) ≥ 2
- The sum score of the OAB V8 ≥ 8
Exclusion
- Any condition that would contraindication of anticholinergic treatment
- Symptomatic acute UTI during the run-in period
- Diagnosed or suspected interstitial cystitis
- Treatment with anticholinergic drugs within 12 months prior to Screening and persist over 3 months
- Treatment within the 14 days preceding Screening, or expected to initiate treatment during the study with any other treatment for overactive bladder.
- An indwelling catheter or practicing intermittent self-catheterization
- Pregnant or nursing women
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
692 Patients enrolled
Trial Details
Trial ID
NCT01515722
Start Date
December 1 2010
End Date
June 1 2012
Last Update
March 20 2020
Active Locations (13)
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1
Bucheon St. Mary's Hospital, The Catholic University of Korea
Bucheon-si, South Korea, 420-717
2
Bucheon Hospital, Soonchunhyang University College of Medicine
Bucheon-si, South Korea, 420-767
3
Samsung Changwon Hospital, Sungkyunkwan University School of Medicine
Changwon, South Korea, 630-522
4
Daegu Catholic University College of Medicine
Daegu, South Korea, 705-034