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Urinary Bladder, OveractiveVESTNCT02087098

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

An observational study of Urinary Bladder, Overactive, run by Astellas Pharma Europe B.V. at 60 sites in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urinary Bladder, Overactive
What is being tested?
Solifenacin
How many people
2,000 participants
Where
60 sitesCzechia
Study dates
Jun 2014to Mar 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with OAB symptoms being treated by urologists in Czech Republic

Who may be able to join

  • 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
Show all 9Show fewer
  • 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)

Who cannot join

  • 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.
Show all 9Show fewer
  • 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

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

Czechia60 sites

  • Site CZ42003 Private Practice

    Benešov

  • Site CZ42001 Private Practice

    Beroun

  • Site CZ42014 Private Practice

    Blansko

  • Site CZ42023 Private Practice

    Boskovice

  • Site CZ42032 Private Practice

    Brno

  • Site CZ42034 Hospital

    Brno

  • Site CZ42035 Private Practice

    Brno

  • Site CZ42036 Private Practice

    Brno

  • Site CZ42038 Private Practice

    Brno

  • Site CZ42039 Private Practice

    Brno

  • Site CZ42058 Hospital

    Brno

  • Site CZ42059 Hospital

    Brno

  • Site CZ42025 Private Practice

    Cheb

  • Site CZ42048 Private Practice

    Dvůr Králové

  • Site CZ42040 Private Practice

    Havlíčkův Brod

  • Site CZ42015 Private Practice

    Hodonín

  • Site CZ42045 Private Practice

    Hradec Králové

  • Site CZ42051 Private Practice

    Jičín

  • Site CZ42027 Private Practice

    Jindřichŭv Hradec

  • Site CZ42029 Private Practice

    Jindřichŭv Hradec

  • Site CZ42026 Private Practice

    Karlovy Vary

  • Site CZ42028 Private Practice

    Karlovy Vary

  • Site CZ42030 Private Practice

    Klatovy

  • Site CZ42049 Private Practice

    Litoměřice

  • Site CZ42021 Private Practice

    Litovel

  • Site CZ42050 Private Practice

    Most

  • Site CZ42054 Private Practice

    Ostrava

  • Site CZ42055 Private Practice

    Ostrava

  • Site CZ42056 Private Practice

    Ostrava

  • Site CZ42057 Private Practice

    Ostrava

  • Site CZ42005 Private Practice

    Pardubice

  • Site CZ42008 Private Practice

    Pardubice

  • Site CZ42024 Private Practice

    Pilsen

  • Site CZ42002 Private Practice

    Prague

  • Site CZ42004 Private Practice

    Prague

  • Site CZ42006 Private Practice

    Prague

  • Site CZ42007 Private Practice

    Prague

  • Site CZ42009 Private Practice

    Prague

  • Site CZ42010 Private Practice

    Prague

  • Site CZ42011 Private Practice

    Prague

  • Site CZ42060 Private Practice

    Prague

  • Site CZ42044 Private Practice

    Roudnice nad Labem

  • Site CZ42031 Private Practice

    Strakonice

  • Site CZ42020 Private Practice

    Svitavy

  • Site CZ42047 Private Practice

    Teplice

  • Site CZ42053 Private Practice

    Teplice

  • Site CZ42042 Private Practice

    Trutnov

  • Site CZ42052 Private Practice

    Turnov

  • Site CZ42018 Hospital

    Uherské Hradiště

  • Site CZ42019 Private Practice

    Uherské Hradiště

  • Site CZ42043 Private Practice

    Ústí nad Labem

  • Site CZ42046 Private Practice

    Ústí nad Labem

  • Site CZ42041 Hospital

    Velké Meziříčí

  • Site CZ42016 Private Practice

    Vsetín

  • Site CZ42017 Private Practice

    Vsetín

  • Site CZ42012 Private Practice

    Zlín

  • Site CZ42013 Private Practice

    Zlín

  • Site CZ42022 Private Practice

    Zlín

  • Site CZ42033 Private Practice

    Znojmo

  • Site CZ42037 Hospital

    Znojmo

Other trials in Czechia

About this study

Official title: 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).

Being tested
Solifenacin
Keywords
overactive bladder, solifenacin, quality of life
Medical subject headings
Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SolifenacinDrug

    Also called Vesicare

    Patients with residual OAB symptoms (urge urinary incontinence, urgency, and frequency) after treatment with other antimuscarinics

Study groups in NCT02087098
Study groupRoleWhat they receive
Patients with residual OAB symptomsUrge urinary incontinence, urgency, and frequency after treatment with other antimuscarinics
Receives: Drug: Solifenacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline of Over Active Bladder questionnaire Short Form (OAB-q SF) score

    Measured: baseline, month 6 and 12

  2. Change from baseline of Patient Assessment of Treatment Satisfaction (TS-VAS)

    Measured: baseline, month 6 and 12

  3. Change from baseline in EuroQol Group system (EQ-5D-5L) score

    Measured: baseline, month 6 and 12

Secondary outcomes (4)

  1. Change in QoL according to previous antimuscarinic treatment and sex (assessed by: TS-VAS score, OAB-q SF score, EQ-5D-5L)

    Measured: baseline, month 1, 3, 6 and 12

  2. Change from baseline in OAB symptoms assessed by micturition diary

    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

    Measured: baseline, month 1, 3, 6 and 12

  3. Persistence to therapy (measured by proportion of Days Covered (PDC, threshold of 80 percent during the measurement period), median length of therapy (days))

    Measured: 12 months

  4. Occurence of adverse drug reaction

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionMar 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02087098
Sponsor's protocol ID
VEST-001
Acronym
VEST
Status last verified
Sep 2016
First submitted
12 Mar 2014
Last updated
13 Sep 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Urinary Bladder, Overactive, run by Astellas Pharma Europe B.V. at 60 sites in Czechia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline of Over Active Bladder questionnaire Short Form (OAB-q SF) score (time frame: baseline, month 6 and 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02087098.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2016.

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