A Study to Evaluate Quality of Life in Patients Switched to Solifenacin From Other Antimuscarinics
- Registration Number
- NCT02087098
- Lead Sponsor
- Astellas Pharma Europe B.V.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2000
-
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)
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with residual OAB symptoms Solifenacin Urge urinary incontinence, urgency, and frequency after treatment with other antimuscarinics
- Primary Outcome Measures
Name Time Method Change from baseline of Patient Assessment of Treatment Satisfaction (TS-VAS) baseline, month 6 and 12 Change from baseline in EuroQol Group system (EQ-5D-5L) score baseline, month 6 and 12 Change from baseline of Over Active Bladder questionnaire Short Form (OAB-q SF) score baseline, month 6 and 12
- Secondary Outcome Measures
Name Time Method 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 Occurence of adverse drug reaction 12 months Change from baseline in OAB symptoms assessed by micturition diary 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
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
Trial Locations
- Locations (60)
Site CZ42001 Private Practice
🇨🇿Beroun, Czech Republic
Site CZ42003 Private Practice
🇨🇿Benešov, Czech Republic
Site CZ42014 Private Practice
🇨🇿Blansko, Czech Republic
Site CZ42039 Private Practice
🇨🇿Brno, Czech Republic
Site CZ42027 Private Practice
🇨🇿Jindřichŭv Hradec, Czech Republic
Site CZ42023 Private Practice
🇨🇿Boskovice, Czech Republic
Site CZ42045 Private Practice
🇨🇿Hradec Králové, Czech Republic
Site CZ42036 Private Practice
🇨🇿Brno, Czech Republic
Site CZ42038 Private Practice
🇨🇿Brno, Czech Republic
Site CZ42055 Private Practice
🇨🇿Ostrava, Czech Republic
Site CZ42005 Private Practice
🇨🇿Pardubice, Czech Republic
Site CZ42056 Private Practice
🇨🇿Ostrava, Czech Republic
Site CZ42057 Private Practice
🇨🇿Ostrava, Czech Republic
Site CZ42052 Private Practice
🇨🇿Turnov, Czech Republic
Site CZ42037 Hospital
🇨🇿Znojmo, Czech Republic
Site CZ42032 Private Practice
🇨🇿Brno, Czech Republic
Site CZ42025 Private Practice
🇨🇿Cheb, Czech Republic
Site CZ42015 Private Practice
🇨🇿Hodonín, Czech Republic
Site CZ42040 Private Practice
🇨🇿Havlíčkův Brod, Czech Republic
Site CZ42011 Private Practice
🇨🇿Praha 10, Czech Republic
Site CZ42031 Private Practice
🇨🇿Strakonice, Czech Republic
Site CZ42033 Private Practice
🇨🇿Znojmo, Czech Republic
Site CZ42046 Private Practice
🇨🇿Ústí nad Labem, Czech Republic
Site CZ42034 Hospital
🇨🇿Brno, Czech Republic
Site CZ42026 Private Practice
🇨🇿Karlovy Vary, Czech Republic
Site CZ42006 Private Practice
🇨🇿Praha 2, Czech Republic
Site CZ42009 Private Practice
🇨🇿Praha 5, Czech Republic
Site CZ42004 Private Practice
🇨🇿Praha 7, Czech Republic
Site CZ42020 Private Practice
🇨🇿Svitavy, Czech Republic
Site CZ42047 Private Practice
🇨🇿Teplice, Czech Republic
Site CZ42019 Private Practice
🇨🇿Uherské Hradiště, Czech Republic
Site CZ42058 Hospital
🇨🇿Brno, Czech Republic
Site CZ42028 Private Practice
🇨🇿Karlovy Vary, Czech Republic
Site CZ42048 Private Practice
🇨🇿Dvůr Králové, Czech Republic
Site CZ42029 Private Practice
🇨🇿Jindřichŭv Hradec, Czech Republic
Site CZ42050 Private Practice
🇨🇿Most, Czech Republic
Site CZ42035 Private Practice
🇨🇿Brno, Czech Republic
Site CZ42051 Private Practice
🇨🇿Jičín, Czech Republic
Site CZ42010 Private Practice
🇨🇿Praha 4, Czech Republic
Site CZ42002 Private Practice
🇨🇿Praha 8, Czech Republic
Site CZ42059 Hospital
🇨🇿Brno, Czech Republic
Site CZ42030 Private Practice
🇨🇿Klatovy, Czech Republic
Site CZ42049 Private Practice
🇨🇿Litoměřice, Czech Republic
Site CZ42021 Private Practice
🇨🇿Litovel, Czech Republic
Site CZ42054 Private Practice
🇨🇿Ostrava, Czech Republic
Site CZ42024 Private Practice
🇨🇿Plzeň, Czech Republic
Site CZ42008 Private Practice
🇨🇿Pardubice, Czech Republic
Site CZ42007 Private Practice
🇨🇿Praha 8, Czech Republic
Site CZ42016 Private Practice
🇨🇿Vsetín, Czech Republic
Site CZ42012 Private Practice
🇨🇿Zlín, Czech Republic
Site CZ42022 Private Practice
🇨🇿Zlín, Czech Republic
Site CZ42060 Private Practice
🇨🇿Praha, Czech Republic
Site CZ42044 Private Practice
🇨🇿Roudnice nad Labem, Czech Republic
Site CZ42053 Private Practice
🇨🇿Teplice, Czech Republic
Site CZ42043 Private Practice
🇨🇿Ústí nad Labem, Czech Republic
Site CZ42042 Private Practice
🇨🇿Trutnov, Czech Republic
Site CZ42018 Hospital
🇨🇿Uherské Hradiště, Czech Republic
Site CZ42041 Hospital
🇨🇿Velké Meziříčí, Czech Republic
Site CZ42017 Private Practice
🇨🇿Vsetín, Czech Republic
Site CZ42013 Private Practice
🇨🇿Zlín, Czech Republic