A Study to Evaluate Quality of Life in Patients Switched to Solifenacin From Other Antimuscarinics
VEST
Czech Observational Study to Evaluate Quality of Life in Patients Switched to Vesicare™ (Solifenacin) From Other Antimuscarinics
1 other identifier
observational
2,000
1 country
60
Brief Summary
This is a 12 month non-interventional study with solifenacin succinate, evaluating the effect of solifenacin on quality of life (QoL) of patients previously treated with antimuscarinics (Males and Females with Overactive Bladder (OAB) symptoms withdrawing their treatment with antimuscarinics because of safety and/or efficacy reasons) - measured by Perception of Treatment Satisfaction (TS-VAS) and to evaluate the effect of solifenacin on quality of life measured by Over Active Bladder-q Short Form (OAB-q SF), EuroQol Group scoring system (EQ-5D-5L).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2014
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2014
CompletedFirst Posted
Study publicly available on registry
March 14, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedSeptember 13, 2016
September 1, 2016
1.8 years
March 12, 2014
September 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change from baseline of Over Active Bladder questionnaire Short Form (OAB-q SF) score
baseline, month 6 and 12
Change from baseline of Patient Assessment of Treatment Satisfaction (TS-VAS)
baseline, month 6 and 12
Change from baseline in EuroQol Group system (EQ-5D-5L) score
baseline, month 6 and 12
Secondary Outcomes (4)
Change in QoL according to previous antimuscarinic treatment and sex (assessed by: TS-VAS score, OAB-q SF score, EQ-5D-5L)
baseline, month 1, 3, 6 and 12
Change from baseline in OAB symptoms assessed by micturition diary
baseline, month 1, 3, 6 and 12
Persistence to therapy (measured by proportion of Days Covered (PDC, threshold of 80 percent during the measurement period), median length of therapy (days))
12 months
Occurence of adverse drug reaction
12 months
Study Arms (1)
Patients with residual OAB symptoms
Urge urinary incontinence, urgency, and frequency after treatment with other antimuscarinics
Interventions
Patients with residual OAB symptoms (urge urinary incontinence, urgency, and frequency) after treatment with other antimuscarinics
Eligibility Criteria
Patients with OAB symptoms being treated by urologists in Czech Republic
You may qualify if:
- Patient willing and able to complete the questionnaires
- 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)
You may not qualify if:
- History of stress incontinence
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Use Central Contact
Astellas Pharma Europe B.V.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2014
First Posted
March 14, 2014
Study Start
June 1, 2014
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
September 13, 2016
Record last verified: 2016-09