Clinical trial NCT00691093: Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy
Official title: Observational Study In Patients With Overactive Bladder (OAB) Treated With Toviaz® After Failure Of Previous Antimuscarinic Therapy Due To Ineffectivity Or Intolerance.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Urinary Incontinence
Keywords: observational
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-06-05
Enrollment: 823
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)

Brief 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.

Detailed description: patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)

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.

Primary outcomes:
measure: Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit
timeFrame: Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)
measure: Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4
timeFrame: Baseline, Month 1, Month 2, Month 3 or ET
measure: Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4
timeFrame: Baseline, Month 1, Month 2, Month 3 or ET
measure: Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4
timeFrame: Baseline, Month 1, Month 2, Month 3 or ET
Secondary outcomes:
measure: Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4
timeFrame: Baseline, Month 1, Month 2, Month 3 or ET
measure: Patient's Global Evaluation of Fesoterodine
timeFrame: Baseline, Month 3 or ET
measure: Clinical Global Evaluation of Fesoterodine
timeFrame: 12 weeks
measure: Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4
timeFrame: Month 3 or ET
measure: Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale
timeFrame: Baseline, Month 3 or ET
measure: Change From Baseline in Total Scores of OAB-q at Visit 4
timeFrame: Baseline, Month 3 or ET
measure: Time To Onset Of Treatment Response
timeFrame: Month 1, Month 2, Month 3 or ET
measure: Study Doses
timeFrame: Month 3 or ET
measure: Reasons for Study Treatment Dose Changes
timeFrame: Month 3 or ET
Other outcomes:
Locations:
city: ?a?a
country: Slovakia
facility: Pfizer Investigational Site
city: Aa
country: Slovakia
facility: Pfizer Investigational Site
city: Adca
country: Slovakia
facility: Pfizer Investigational Site
city: B.Bystrica
country: Slovakia
facility: Pfizer Investigational Site
city: Banska Bystrica
country: Slovakia
facility: Pfizer Investigational Site
city: Bardejov
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava 2
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava 2
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava 4
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava 5
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava 5
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Dolny Kubin
country: Slovakia
facility: Pfizer Investigational Site
city: Dunajska Streda
country: Slovakia
facility: Pfizer Investigational Site
city: Hlohovec
country: Slovakia
facility: Pfizer Investigational Site
city: Humenne
country: Slovakia
facility: Pfizer Investigational Site
city: Ilina
country: Slovakia
facility: Pfizer Investigational Site
city: Koice-aca
country: Slovakia
facility: Pfizer Investigational Site
city: Koice
country: Slovakia
facility: Pfizer Investigational Site
city: Komarno
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Kraovsky Chlmec
country: Slovakia
facility: Pfizer Investigational Site
city: Liptovsky Hradok
country: Slovakia
facility: Pfizer Investigational Site
city: Liptovsky Mikulas
country: Slovakia
facility: Pfizer Investigational Site
city: Luenec
country: Slovakia
facility: Pfizer Investigational Site
city: Malacky
country: Slovakia
facility: Pfizer Investigational Site
city: Malacky
country: Slovakia
facility: Pfizer Investigational Site
city: Martin
country: Slovakia
facility: Pfizer Investigational Site
city: Michalovce
country: Slovakia
facility: Pfizer Investigational Site
city: Myjava
country: Slovakia
facility: Pfizer Investigational Site
city: Namestovo
country: Slovakia
facility: Pfizer Investigational Site
city: Nitra
country: Slovakia
facility: Pfizer Investigational Site
city: Nitra
country: Slovakia
facility: Pfizer Investigational Site
city: Nitra
country: Slovakia
facility: Pfizer Investigational Site
city: Nove Zamky
country: Slovakia
facility: Pfizer Investigational Site
city: Nové Zámky
country: Slovakia
facility: Pfizer Investigational Site
city: Piestany
country: Slovakia
facility: Pfizer Investigational Site
city: Poprad
country: Slovakia
facility: Pfizer Investigational Site
city: Povaska Bystrica
country: Slovakia
facility: Pfizer Investigational Site
city: Povazska Bystrica
country: Slovakia
facility: Pfizer Investigational Site
city: Preov
country: Slovakia
facility: Pfizer Investigational Site
city: Prievidza
country: Slovakia
facility: Pfizer Investigational Site
city: Puchov
country: Slovakia
facility: Pfizer Investigational Site
city: Revuca
country: Slovakia
facility: Pfizer Investigational Site
city: Rimavska Sobota
country: Slovakia
facility: Pfizer Investigational Site
city: Ruomberok
country: Slovakia
facility: Pfizer Investigational Site
city: Ruzomberok
country: Slovakia
facility: Pfizer Investigational Site
city: Senica
country: Slovakia
facility: Pfizer Investigational Site
city: Skalica
country: Slovakia
facility: Pfizer Investigational Site
city: Sobrance
country: Slovakia
facility: Pfizer Investigational Site
city: SpisskaNova Ves
country: Slovakia
facility: Pfizer Investigational Site
city: Stropkov
country: Slovakia
facility: Pfizer Investigational Site
city: Svidnik
country: Slovakia
facility: Pfizer Investigational Site
city: Topoany
country: Slovakia
facility: Pfizer Investigational Site
city: Trebisov
country: Slovakia
facility: Pfizer Investigational Site
city: Trencin
country: Slovakia
facility: Pfizer Investigational Site
city: Trenin
country: Slovakia
facility: Pfizer Investigational Site
city: Trnava
country: Slovakia
facility: Pfizer Investigational Site
city: Turianske Teplice
country: Slovakia
facility: Pfizer Investigational Site
city: Urany
country: Slovakia
facility: Pfizer Investigational Site
city: Vrable
country: Slovakia
facility: Pfizer Investigational Site
city: Vranov n/Topou
country: Slovakia
facility: Pfizer Investigational Site
city: Zvolen
country: Slovakia
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: