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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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