N/A
N=823
Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy
Overactive Bladder · Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT00691093 ↗Enrolled (actual)
823
Serious AEs
0.0%
Results posted
Nov 2010
Primary outcome: Primary: Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit — 11.661; 10.636; 12.664; -2.306 episodes
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- fesoterodine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit |
11.661; 10.636; 12.664; -2.306; -2.303; -1.566 | — |
| PRIMARY Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4 |
3.027; 4.000; 3.528; -1.104; -1.212; -0.915 | — |
| PRIMARY Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4 |
4.412; 4.697; 5.587; -1.890; -1.697; -1.650 | — |
| PRIMARY Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4 |
2.601; 2.933; 3.467; -1.209; -1.067; -1.190 | — |
| SECONDARY Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4 |
27.932; 42.000; 24.867; -6.650; -12.800; -2.364 | — |
| SECONDARY Patient's Global Evaluation of Fesoterodine |
536; 252; 22; 10; 3 | — |
| SECONDARY Clinical Global Evaluation of Fesoterodine |
513; 274; 24; 9; 3 | — |
| SECONDARY Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4 |
5.661; 5.818; 4.702 | — |
| SECONDARY Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale |
59.263; 70.000; 64.737; 25.147; 35.682; 32.719 | — |
| SECONDARY Change From Baseline in Total Scores of OAB-q at Visit 4 |
-34.101; -34.318; -32.018 | — |
| SECONDARY Time To Onset Of Treatment Response |
3.0; 3.0; 3.0 | — |
| SECONDARY Study Doses |
57; 766; 0; 0 | — |
| SECONDARY Reasons for Study Treatment Dose Changes |
22; 29; 1; 1; 1; 4 | — |
Summary
This is a observational study in patients treated with fesoterodine (Toviaz), who have failed on previous treatment for overactive bladder. It will collect epidemiological data and investigate the efficacy and tolerability of fesoterodine.
Eligibility Criteria
Inclusion Criteria
- Patients older than 18 years
- Patients with OAB after failure of previous antimuscarinic therapy - due to lack of efficacy: persistence of storage symptoms.
- Required symptoms: micturition frequency 8 and more / 24 hours and urgency episodes ≥2 per day subjectively perceived as bothersome
- Due to intolerance: persistent and/or unacceptable adverse events
Exclusion Criteria
- Hypersensitivity to the active substance or to peanut or soya or any of the excipients.
- History of acute urinary retention (requiring catheterisation)
- Gastric retention
- Uncontrolled narrow angle glaucoma
- Myasthenia gravis
- Severe hepatic impairment (Child Pugh C)
- Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment
- Severe ulcerative colitis
- Toxic megacolon.
Data sourced from ClinicalTrials.gov (NCT00691093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.