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

September 12, 2016 updated by: Astellas Pharma Europe B.V.

Czech Observational Study to Evaluate Quality of Life in Patients Switched to Vesicare™ (Solifenacin) From Other Antimuscarinics

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Benešov, Czech Republic
        • Site CZ42003 Private Practice
      • Beroun, Czech Republic
        • Site CZ42001 Private Practice
      • Blansko, Czech Republic
        • Site CZ42014 Private Practice
      • Boskovice, Czech Republic
        • Site CZ42023 Private Practice
      • Brno, Czech Republic
        • Site CZ42032 Private Practice
      • Brno, Czech Republic
        • Site CZ42034 Hospital
      • Brno, Czech Republic
        • Site CZ42035 Private Practice
      • Brno, Czech Republic
        • Site CZ42036 Private Practice
      • Brno, Czech Republic
        • Site CZ42038 Private Practice
      • Brno, Czech Republic
        • Site CZ42039 Private Practice
      • Brno, Czech Republic
        • Site CZ42058 Hospital
      • Brno, Czech Republic
        • Site CZ42059 Hospital
      • Cheb, Czech Republic
        • Site CZ42025 Private Practice
      • Dvůr Králové, Czech Republic
        • Site CZ42048 Private Practice
      • Havlíčkův Brod, Czech Republic
        • Site CZ42040 Private Practice
      • Hodonín, Czech Republic
        • Site CZ42015 Private Practice
      • Hradec Králové, Czech Republic
        • Site CZ42045 Private Practice
      • Jindřichŭv Hradec, Czech Republic
        • Site CZ42027 Private Practice
      • Jindřichŭv Hradec, Czech Republic
        • Site CZ42029 Private Practice
      • Jičín, Czech Republic
        • Site CZ42051 Private Practice
      • Karlovy Vary, Czech Republic
        • Site CZ42026 Private Practice
      • Karlovy Vary, Czech Republic
        • Site CZ42028 Private Practice
      • Klatovy, Czech Republic
        • Site CZ42030 Private Practice
      • Litoměřice, Czech Republic
        • Site CZ42049 Private Practice
      • Litovel, Czech Republic
        • Site CZ42021 Private Practice
      • Most, Czech Republic
        • Site CZ42050 Private Practice
      • Ostrava, Czech Republic
        • Site CZ42054 Private Practice
      • Ostrava, Czech Republic
        • Site CZ42055 Private Practice
      • Ostrava, Czech Republic
        • Site CZ42056 Private Practice
      • Ostrava, Czech Republic
        • Site CZ42057 Private Practice
      • Pardubice, Czech Republic
        • Site CZ42005 Private Practice
      • Pardubice, Czech Republic
        • Site CZ42008 Private Practice
      • Plzeň, Czech Republic
        • Site CZ42024 Private Practice
      • Praha, Czech Republic
        • Site CZ42060 Private Practice
      • Praha 10, Czech Republic
        • Site CZ42011 Private Practice
      • Praha 2, Czech Republic
        • Site CZ42006 Private Practice
      • Praha 4, Czech Republic
        • Site CZ42010 Private Practice
      • Praha 5, Czech Republic
        • Site CZ42009 Private Practice
      • Praha 7, Czech Republic
        • Site CZ42004 Private Practice
      • Praha 8, Czech Republic
        • Site CZ42002 Private Practice
      • Praha 8, Czech Republic
        • Site CZ42007 Private Practice
      • Roudnice nad Labem, Czech Republic
        • Site CZ42044 Private Practice
      • Strakonice, Czech Republic
        • Site CZ42031 Private Practice
      • Svitavy, Czech Republic
        • Site CZ42020 Private Practice
      • Teplice, Czech Republic
        • Site CZ42047 Private Practice
      • Teplice, Czech Republic
        • Site CZ42053 Private Practice
      • Trutnov, Czech Republic
        • Site CZ42042 Private Practice
      • Turnov, Czech Republic
        • Site CZ42052 Private Practice
      • Uherské Hradiště, Czech Republic
        • Site CZ42018 Hospital
      • Uherské Hradiště, Czech Republic
        • Site CZ42019 Private Practice
      • Velké Meziříčí, Czech Republic
        • Site CZ42041 Hospital
      • Vsetín, Czech Republic
        • Site CZ42016 Private Practice
      • Vsetín, Czech Republic
        • Site CZ42017 Private Practice
      • Zlín, Czech Republic
        • Site CZ42012 Private Practice
      • Zlín, Czech Republic
        • Site CZ42013 Private Practice
      • Zlín, Czech Republic
        • Site CZ42022 Private Practice
      • Znojmo, Czech Republic
        • Site CZ42033 Private Practice
      • Znojmo, Czech Republic
        • Site CZ42037 Hospital
      • Ústí nad Labem, Czech Republic
        • Site CZ42043 Private Practice
      • Ústí nad Labem, Czech Republic
        • Site CZ42046 Private Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with OAB symptoms being treated by urologists in Czech Republic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline of Over Active Bladder questionnaire Short Form (OAB-q SF) score
Time Frame: baseline, month 6 and 12
baseline, month 6 and 12
Change from baseline of Patient Assessment of Treatment Satisfaction (TS-VAS)
Time Frame: baseline, month 6 and 12
baseline, month 6 and 12
Change from baseline in EuroQol Group system (EQ-5D-5L) score
Time Frame: baseline, month 6 and 12
baseline, month 6 and 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in QoL according to previous antimuscarinic treatment and sex (assessed by: TS-VAS score, OAB-q SF score, EQ-5D-5L)
Time Frame: baseline, month 1, 3, 6 and 12
baseline, month 1, 3, 6 and 12
Change from baseline in OAB symptoms assessed by micturition diary
Time Frame: 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
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))
Time Frame: 12 months
12 months
Occurence of adverse drug reaction
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Europe B.V.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

March 12, 2014

First Submitted That Met QC Criteria

March 12, 2014

First Posted (ESTIMATE)

March 14, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEST-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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