Urinary Bladder, Overactive
Conditions
Keywords
overactive bladder, solifenacin, quality of life
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).
Interventions
DRUGSolifenacin
Patients with residual OAB symptoms (urge urinary incontinence, urgency, and frequency) after treatment with other antimuscarinics
Sponsors
Astellas Pharma Europe B.V.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline of Over Active Bladder questionnaire Short Form (OAB-q SF) score | baseline, month 6 and 12 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Czechia
Outcome results
None listed