A Study to Evaluate Quality of Life in Patients Switched to Solifenacin From Other Antimuscarinics
NCT ID: NCT02087098
Last Updated: 2016-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2000 participants
OBSERVATIONAL
2014-06-30
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with residual OAB symptoms
Urge urinary incontinence, urgency, and frequency after treatment with other antimuscarinics
Solifenacin
Patients with residual OAB symptoms (urge urinary incontinence, urgency, and frequency) after treatment with other antimuscarinics
Interventions
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Solifenacin
Patients with residual OAB symptoms (urge urinary incontinence, urgency, and frequency) after treatment with other antimuscarinics
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of OAB
* Previous unsuccessful OAB medication (antimuscarinic treatment for at least 1 month) less than 4 weeks ago defined by:
* number of micturitions \> 8/24 h or
* decrease in urgency urinary incontinence (UUI) or incontinence episodes / 24 h less than 50% or
* decrease in urgency episodes / 24 h less than 50% or
* decrease in number of micturitions / 24 h less than 20% or
* not acceptable tolerability
* Eligible to start Vesicare™ 5 or 10 mg according to Summary of Product Characteristics (SmPC)
Exclusion Criteria
* Active urinary tract infection (confirmed by positive urine analysis)
* Symptoms suggestive of severe Bladder Outlet Obstruction (BOO) defined as Peak urinary flow rate (Qmax) \< 10ml/sc and/or Postvoid residual urine volume (PVR) \> 150 ml
* Uncontrolled Diabetes Mellitus
* History of drug and/or alcohol abuse at the time of enrolment
* History of acute urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony or toxic megacolon or severe ulcerative colitis), myasthenia gravis, uncontrolled narrow glaucoma or swallow anterior chamber or deemed to be at risk for these conditions.
* Undergoing hemodialysis or has severe renal impairment or moderate hepatic impairment and who are on treatment with a potent CYP3A4 inhibitor
* Previous treatment with solifenacin
* Likely to participate in another study during study period of 12 months from study entry
18 Years
ALL
No
Sponsors
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Astellas Pharma Europe B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma Europe B.V.
Locations
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Site CZ42003 Private Practice
Benešov, , Czechia
Site CZ42001 Private Practice
Beroun, , Czechia
Site CZ42014 Private Practice
Blansko, , Czechia
Site CZ42023 Private Practice
Boskovice, , Czechia
Site CZ42032 Private Practice
Brno, , Czechia
Site CZ42034 Hospital
Brno, , Czechia
Site CZ42035 Private Practice
Brno, , Czechia
Site CZ42036 Private Practice
Brno, , Czechia
Site CZ42038 Private Practice
Brno, , Czechia
Site CZ42039 Private Practice
Brno, , Czechia
Site CZ42058 Hospital
Brno, , Czechia
Site CZ42059 Hospital
Brno, , Czechia
Site CZ42025 Private Practice
Cheb, , Czechia
Site CZ42048 Private Practice
Dvůr Králové, , Czechia
Site CZ42040 Private Practice
Havlíčkův Brod, , Czechia
Site CZ42015 Private Practice
Hodonín, , Czechia
Site CZ42045 Private Practice
Hradec Králové, , Czechia
Site CZ42051 Private Practice
Jičín, , Czechia
Site CZ42027 Private Practice
Jindřichŭv Hradec, , Czechia
Site CZ42029 Private Practice
Jindřichŭv Hradec, , Czechia
Site CZ42026 Private Practice
Karlovy Vary, , Czechia
Site CZ42028 Private Practice
Karlovy Vary, , Czechia
Site CZ42030 Private Practice
Klatovy, , Czechia
Site CZ42049 Private Practice
Litoměřice, , Czechia
Site CZ42021 Private Practice
Litovel, , Czechia
Site CZ42050 Private Practice
Most, , Czechia
Site CZ42054 Private Practice
Ostrava, , Czechia
Site CZ42055 Private Practice
Ostrava, , Czechia
Site CZ42056 Private Practice
Ostrava, , Czechia
Site CZ42057 Private Practice
Ostrava, , Czechia
Site CZ42005 Private Practice
Pardubice, , Czechia
Site CZ42008 Private Practice
Pardubice, , Czechia
Site CZ42024 Private Practice
Pilsen, , Czechia
Site CZ42002 Private Practice
Prague, , Czechia
Site CZ42004 Private Practice
Prague, , Czechia
Site CZ42006 Private Practice
Prague, , Czechia
Site CZ42007 Private Practice
Prague, , Czechia
Site CZ42009 Private Practice
Prague, , Czechia
Site CZ42010 Private Practice
Prague, , Czechia
Site CZ42011 Private Practice
Prague, , Czechia
Site CZ42060 Private Practice
Prague, , Czechia
Site CZ42044 Private Practice
Roudnice nad Labem, , Czechia
Site CZ42031 Private Practice
Strakonice, , Czechia
Site CZ42020 Private Practice
Svitavy, , Czechia
Site CZ42047 Private Practice
Teplice, , Czechia
Site CZ42053 Private Practice
Teplice, , Czechia
Site CZ42042 Private Practice
Trutnov, , Czechia
Site CZ42052 Private Practice
Turnov, , Czechia
Site CZ42018 Hospital
Uherské Hradiště, , Czechia
Site CZ42019 Private Practice
Uherské Hradiště, , Czechia
Site CZ42043 Private Practice
Ústí nad Labem, , Czechia
Site CZ42046 Private Practice
Ústí nad Labem, , Czechia
Site CZ42041 Hospital
Velké Meziříčí, , Czechia
Site CZ42016 Private Practice
Vsetín, , Czechia
Site CZ42017 Private Practice
Vsetín, , Czechia
Site CZ42012 Private Practice
Zlín, , Czechia
Site CZ42013 Private Practice
Zlín, , Czechia
Site CZ42022 Private Practice
Zlín, , Czechia
Site CZ42033 Private Practice
Znojmo, , Czechia
Site CZ42037 Hospital
Znojmo, , Czechia
Countries
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Other Identifiers
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VEST-001
Identifier Type: -
Identifier Source: org_study_id
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