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VEST: A Study to Evaluate Quality of Life in Patients Switched to Solifenacin From Other Antimuscarinics

Sponsor
Astellas Pharma Europe B.V. (Industry)
Overall Status
Completed
CT.gov ID
NCT02087098
Collaborator
(none)
2,000
Enrollment
60
Locations
21
Duration (Months)
33.3
Patients Per Site
1.6
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
2000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Czech Observational Study to Evaluate Quality of Life in Patients Switched to Vesicare™ (Solifenacin) From Other Antimuscarinics
Study Start Date :
Jun 1, 2014
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Patients with residual OAB symptoms

Urge urinary incontinence, urgency, and frequency after treatment with other antimuscarinics

Drug: Solifenacin
Patients with residual OAB symptoms (urge urinary incontinence, urgency, and frequency) after treatment with other antimuscarinics
Other Names:
  • Vesicare

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline of Over Active Bladder questionnaire Short Form (OAB-q SF) score [baseline, month 6 and 12]

    2. Change from baseline of Patient Assessment of Treatment Satisfaction (TS-VAS) [baseline, month 6 and 12]

    3. Change from baseline in EuroQol Group system (EQ-5D-5L) score [baseline, month 6 and 12]

    Secondary Outcome Measures

    1. 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]

    2. Change from baseline in OAB symptoms assessed by micturition diary [baseline, month 1, 3, 6 and 12]

      Mean number of urgency episode per 24 hours, mean number of micturition per 24 hours, mean number of nocturia episodes per 24 hours, mean number of urge incontinence (UUI) episodes per week

    3. 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]

    4. Occurence of adverse drug reaction [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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)

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site CZ42003 Private Practice Benešov Czech Republic
    2 Site CZ42001 Private Practice Beroun Czech Republic
    3 Site CZ42014 Private Practice Blansko Czech Republic
    4 Site CZ42023 Private Practice Boskovice Czech Republic
    5 Site CZ42032 Private Practice Brno Czech Republic
    6 Site CZ42034 Hospital Brno Czech Republic
    7 Site CZ42035 Private Practice Brno Czech Republic
    8 Site CZ42036 Private Practice Brno Czech Republic
    9 Site CZ42038 Private Practice Brno Czech Republic
    10 Site CZ42039 Private Practice Brno Czech Republic
    11 Site CZ42058 Hospital Brno Czech Republic
    12 Site CZ42059 Hospital Brno Czech Republic
    13 Site CZ42025 Private Practice Cheb Czech Republic
    14 Site CZ42048 Private Practice Dvůr Králové Czech Republic
    15 Site CZ42040 Private Practice Havlíčkův Brod Czech Republic
    16 Site CZ42015 Private Practice Hodonín Czech Republic
    17 Site CZ42045 Private Practice Hradec Králové Czech Republic
    18 Site CZ42027 Private Practice Jindřichŭv Hradec Czech Republic
    19 Site CZ42029 Private Practice Jindřichŭv Hradec Czech Republic
    20 Site CZ42051 Private Practice Jičín Czech Republic
    21 Site CZ42026 Private Practice Karlovy Vary Czech Republic
    22 Site CZ42028 Private Practice Karlovy Vary Czech Republic
    23 Site CZ42030 Private Practice Klatovy Czech Republic
    24 Site CZ42049 Private Practice Litoměřice Czech Republic
    25 Site CZ42021 Private Practice Litovel Czech Republic
    26 Site CZ42050 Private Practice Most Czech Republic
    27 Site CZ42054 Private Practice Ostrava Czech Republic
    28 Site CZ42055 Private Practice Ostrava Czech Republic
    29 Site CZ42056 Private Practice Ostrava Czech Republic
    30 Site CZ42057 Private Practice Ostrava Czech Republic
    31 Site CZ42005 Private Practice Pardubice Czech Republic
    32 Site CZ42008 Private Practice Pardubice Czech Republic
    33 Site CZ42024 Private Practice Plzeň Czech Republic
    34 Site CZ42011 Private Practice Praha 10 Czech Republic
    35 Site CZ42006 Private Practice Praha 2 Czech Republic
    36 Site CZ42010 Private Practice Praha 4 Czech Republic
    37 Site CZ42009 Private Practice Praha 5 Czech Republic
    38 Site CZ42004 Private Practice Praha 7 Czech Republic
    39 Site CZ42002 Private Practice Praha 8 Czech Republic
    40 Site CZ42007 Private Practice Praha 8 Czech Republic
    41 Site CZ42060 Private Practice Praha Czech Republic
    42 Site CZ42044 Private Practice Roudnice nad Labem Czech Republic
    43 Site CZ42031 Private Practice Strakonice Czech Republic
    44 Site CZ42020 Private Practice Svitavy Czech Republic
    45 Site CZ42047 Private Practice Teplice Czech Republic
    46 Site CZ42053 Private Practice Teplice Czech Republic
    47 Site CZ42042 Private Practice Trutnov Czech Republic
    48 Site CZ42052 Private Practice Turnov Czech Republic
    49 Site CZ42018 Hospital Uherské Hradiště Czech Republic
    50 Site CZ42019 Private Practice Uherské Hradiště Czech Republic
    51 Site CZ42041 Hospital Velké Meziříčí Czech Republic
    52 Site CZ42016 Private Practice Vsetín Czech Republic
    53 Site CZ42017 Private Practice Vsetín Czech Republic
    54 Site CZ42012 Private Practice Zlín Czech Republic
    55 Site CZ42013 Private Practice Zlín Czech Republic
    56 Site CZ42022 Private Practice Zlín Czech Republic
    57 Site CZ42033 Private Practice Znojmo Czech Republic
    58 Site CZ42037 Hospital Znojmo Czech Republic
    59 Site CZ42043 Private Practice Ústí nad Labem Czech Republic
    60 Site CZ42046 Private Practice Ústí nad Labem Czech Republic

    Sponsors and Collaborators

    • Astellas Pharma Europe B.V.

    Investigators

    • Study Director: Use Central Contact, Astellas Pharma Europe B.V.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Europe B.V.
    ClinicalTrials.gov Identifier:
    NCT02087098
    Other Study ID Numbers:
    • VEST-001
    First Posted:
    Mar 14, 2014
    Last Update Posted:
    Sep 13, 2016
    Last Verified:
    Sep 1, 2016
    Keywords provided by Astellas Pharma Europe B.V.
    overactive bladder
    solifenacin
    quality of life
    Additional relevant MeSH terms:
    Urinary Bladder, Overactive
    Solifenacin Succinate

    Study Results

    No Results Posted as of Sep 13, 2016