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

Urinary Bladder, Overactive Clinical Trial

— VEST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02087098
• Other study ID #: VEST-001
• Status: Completed
• Phase: N/A
• First received: March 12, 2014
• Last updated: September 12, 2016
• Start date: June 2014
• Est. completion date: March 2016

Study information

• Verified date: September 2016
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Observational

Clinical 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

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

Locations

Country	Name	City	State
Czech Republic	Site CZ42003 Private Practice	Benešov
Czech Republic	Site CZ42001 Private Practice	Beroun
Czech Republic	Site CZ42014 Private Practice	Blansko
Czech Republic	Site CZ42023 Private Practice	Boskovice
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	Brno
Czech Republic	Site CZ42025 Private Practice	Cheb
Czech Republic	Site CZ42048 Private Practice	Dvur Králové
Czech Republic	Site CZ42040 Private Practice	Havlíckuv Brod
Czech Republic	Site CZ42015 Private Practice	Hodonín
Czech Republic	Site CZ42045 Private Practice	Hradec Králové
Czech Republic	Site CZ42051 Private Practice	Jicín
Czech Republic	Site CZ42027 Private Practice	Jindrichuv Hradec
Czech Republic	Site CZ42029 Private Practice	Jindrichuv Hradec
Czech Republic	Site CZ42026 Private Practice	Karlovy Vary
Czech Republic	Site CZ42028 Private Practice	Karlovy Vary
Czech Republic	Site CZ42030 Private Practice	Klatovy
Czech Republic	Site CZ42049 Private Practice	Litomerice
Czech Republic	Site CZ42021 Private Practice	Litovel
Czech Republic	Site CZ42050 Private Practice	Most
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	Ostrava
Czech Republic	Site CZ42005 Private Practice	Pardubice
Czech Republic	Site CZ42008 Private Practice	Pardubice
Czech Republic	Site CZ42024 Private Practice	Plzen
Czech Republic	Site CZ42060 Private Practice	Praha
Czech Republic	Site CZ42011 Private Practice	Praha 10
Czech Republic	Site CZ42006 Private Practice	Praha 2
Czech Republic	Site CZ42010 Private Practice	Praha 4
Czech Republic	Site CZ42009 Private Practice	Praha 5
Czech Republic	Site CZ42004 Private Practice	Praha 7
Czech Republic	Site CZ42002 Private Practice	Praha 8
Czech Republic	Site CZ42007 Private Practice	Praha 8
Czech Republic	Site CZ42044 Private Practice	Roudnice nad Labem
Czech Republic	Site CZ42031 Private Practice	Strakonice
Czech Republic	Site CZ42020 Private Practice	Svitavy
Czech Republic	Site CZ42047 Private Practice	Teplice
Czech Republic	Site CZ42053 Private Practice	Teplice
Czech Republic	Site CZ42042 Private Practice	Trutnov
Czech Republic	Site CZ42052 Private Practice	Turnov
Czech Republic	Site CZ42018 Hospital	Uherské Hradište
Czech Republic	Site CZ42019 Private Practice	Uherské Hradište
Czech Republic	Site CZ42043 Private Practice	Ústí nad Labem
Czech Republic	Site CZ42046 Private Practice	Ústí nad Labem
Czech Republic	Site CZ42041 Hospital	Velké Mezirící
Czech Republic	Site CZ42016 Private Practice	Vsetín
Czech Republic	Site CZ42017 Private Practice	Vsetín
Czech Republic	Site CZ42012 Private Practice	Zlín
Czech Republic	Site CZ42013 Private Practice	Zlín
Czech Republic	Site CZ42022 Private Practice	Zlín
Czech Republic	Site CZ42033 Private Practice	Znojmo
Czech Republic	Site CZ42037 Hospital	Znojmo

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe B.V.

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of Over Active Bladder questionnaire Short Form (OAB-q SF) score		baseline, month 6 and 12	No
Primary	Change from baseline of Patient Assessment of Treatment Satisfaction (TS-VAS)		baseline, month 6 and 12	No
Primary	Change from baseline in EuroQol Group system (EQ-5D-5L) score		baseline, month 6 and 12	No
Secondary	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	No
Secondary	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	baseline, month 1, 3, 6 and 12	No
Secondary	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	No
Secondary	Occurence of adverse drug reaction		12 months	Yes