Clinical trial NCT02087098: A Study to Evaluate Quality of Life in Patients Switched to Solifenacin From Other Antimuscarinics
Official title: Czech Observational Study to Evaluate Quality of Life in Patients Switched to Vesicare™ (Solifenacin) From Other Antimuscarinics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Bladder, Overactive
Keywords: overactive bladder
solifenacin
quality of life
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-03-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with OAB symptoms being treated by urologists in Czech Republic

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of Over Active Bladder questionnaire Short Form (OAB-q SF) score
timeFrame: baseline, month 6 and 12
measure: Change from baseline of Patient Assessment of Treatment Satisfaction (TS-VAS)
timeFrame: baseline, month 6 and 12
measure: Change from baseline in EuroQol Group system (EQ-5D-5L) score
timeFrame: baseline, month 6 and 12
Secondary outcomes:
measure: Change in QoL according to previous antimuscarinic treatment and sex (assessed by: TS-VAS score, OAB-q SF score, EQ-5D-5L)
timeFrame: baseline, month 1, 3, 6 and 12
measure: Change from baseline in OAB symptoms assessed by micturition diary
timeFrame: baseline, month 1, 3, 6 and 12
measure: Persistence to therapy (measured by proportion of Days Covered (PDC, threshold of 80 percent during the measurement period), median length of therapy (days))
timeFrame: 12 months
measure: Occurence of adverse drug reaction
timeFrame: 12 months
Other outcomes:
Locations:
city: Benešov
country: Czech Republic
facility: Site CZ42003 Private Practice
city: Beroun
country: Czech Republic
facility: Site CZ42001 Private Practice
city: Blansko
country: Czech Republic
facility: Site CZ42014 Private Practice
city: Boskovice
country: Czech Republic
facility: Site CZ42023 Private Practice
city: Brno
country: Czech Republic
facility: Site CZ42032 Private Practice
city: Brno
country: Czech Republic
facility: Site CZ42034 Hospital
city: Brno
country: Czech Republic
facility: Site CZ42035 Private Practice
city: Brno
country: Czech Republic
facility: Site CZ42036 Private Practice
city: Brno
country: Czech Republic
facility: Site CZ42038 Private Practice
city: Brno
country: Czech Republic
facility: Site CZ42039 Private Practice
city: Brno
country: Czech Republic
facility: Site CZ42058 Hospital
city: Brno
country: Czech Republic
facility: Site CZ42059 Hospital
city: Cheb
country: Czech Republic
facility: Site CZ42025 Private Practice
city: Dvůr Králové
country: Czech Republic
facility: Site CZ42048 Private Practice
city: Havlíčkův Brod
country: Czech Republic
facility: Site CZ42040 Private Practice
city: Hodonín
country: Czech Republic
facility: Site CZ42015 Private Practice
city: Hradec Králové
country: Czech Republic
facility: Site CZ42045 Private Practice
city: Jindřichŭv Hradec
country: Czech Republic
facility: Site CZ42027 Private Practice
city: Jindřichŭv Hradec
country: Czech Republic
facility: Site CZ42029 Private Practice
city: Jičín
country: Czech Republic
facility: Site CZ42051 Private Practice
city: Karlovy Vary
country: Czech Republic
facility: Site CZ42026 Private Practice
city: Karlovy Vary
country: Czech Republic
facility: Site CZ42028 Private Practice
city: Klatovy
country: Czech Republic
facility: Site CZ42030 Private Practice
city: Litoměřice
country: Czech Republic
facility: Site CZ42049 Private Practice
city: Litovel
country: Czech Republic
facility: Site CZ42021 Private Practice
city: Most
country: Czech Republic
facility: Site CZ42050 Private Practice
city: Ostrava
country: Czech Republic
facility: Site CZ42054 Private Practice
city: Ostrava
country: Czech Republic
facility: Site CZ42055 Private Practice
city: Ostrava
country: Czech Republic
facility: Site CZ42056 Private Practice
city: Ostrava
country: Czech Republic
facility: Site CZ42057 Private Practice
city: Pardubice
country: Czech Republic
facility: Site CZ42005 Private Practice
city: Pardubice
country: Czech Republic
facility: Site CZ42008 Private Practice
city: Plzeň
country: Czech Republic
facility: Site CZ42024 Private Practice
city: Praha 10
country: Czech Republic
facility: Site CZ42011 Private Practice
city: Praha 2
country: Czech Republic
facility: Site CZ42006 Private Practice
city: Praha 4
country: Czech Republic
facility: Site CZ42010 Private Practice
city: Praha 5
country: Czech Republic
facility: Site CZ42009 Private Practice
city: Praha 7
country: Czech Republic
facility: Site CZ42004 Private Practice
city: Praha 8
country: Czech Republic
facility: Site CZ42002 Private Practice
city: Praha 8
country: Czech Republic
facility: Site CZ42007 Private Practice
city: Praha
country: Czech Republic
facility: Site CZ42060 Private Practice
city: Roudnice nad Labem
country: Czech Republic
facility: Site CZ42044 Private Practice
city: Strakonice
country: Czech Republic
facility: Site CZ42031 Private Practice
city: Svitavy
country: Czech Republic
facility: Site CZ42020 Private Practice
city: Teplice
country: Czech Republic
facility: Site CZ42047 Private Practice
city: Teplice
country: Czech Republic
facility: Site CZ42053 Private Practice
city: Trutnov
country: Czech Republic
facility: Site CZ42042 Private Practice
city: Turnov
country: Czech Republic
facility: Site CZ42052 Private Practice
city: Uherské Hradiště
country: Czech Republic
facility: Site CZ42018 Hospital
city: Uherské Hradiště
country: Czech Republic
facility: Site CZ42019 Private Practice
city: Velké Meziříčí
country: Czech Republic
facility: Site CZ42041 Hospital
city: Vsetín
country: Czech Republic
facility: Site CZ42016 Private Practice
city: Vsetín
country: Czech Republic
facility: Site CZ42017 Private Practice
city: Zlín
country: Czech Republic
facility: Site CZ42012 Private Practice
city: Zlín
country: Czech Republic
facility: Site CZ42013 Private Practice
city: Zlín
country: Czech Republic
facility: Site CZ42022 Private Practice
city: Znojmo
country: Czech Republic
facility: Site CZ42033 Private Practice
city: Znojmo
country: Czech Republic
facility: Site CZ42037 Hospital
city: Ústí nad Labem
country: Czech Republic
facility: Site CZ42043 Private Practice
city: Ústí nad Labem
country: Czech Republic
facility: Site CZ42046 Private Practice
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Use Central Contact
role: STUDY_DIRECTOR
References: