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Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy

NCT ID: NCT00691093

Last Updated: 2018-11-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

823 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-06-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Overactive Bladder Urinary Incontinence

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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fesoterodine

fesoterodine

Intervention Type DRUG

4 mg per 24 hours, possibility to increase to 8 mg depending on efficacy chronic treatment

Interventions

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fesoterodine

4 mg per 24 hours, possibility to increase to 8 mg depending on efficacy chronic treatment

Intervention Type DRUG

Other Intervention Names

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TOVIAZ

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

?a?a, , Slovakia

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Pfizer Investigational Site

Aa, , Slovakia

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Adca, , Slovakia

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B.Bystrica, , Slovakia

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Banská Bystrica, , Slovakia

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Bardejov, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Dolný Kubín, , Slovakia

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Dunajská Streda, , Slovakia

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Hlohovec, , Slovakia

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Humenné, , Slovakia

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Ilina, , Slovakia

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Koice-aca, , Slovakia

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Koice, , Slovakia

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Komárno, , Slovakia

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Košice, , Slovakia

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Košice, , Slovakia

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Kraovsky Chlmec, , Slovakia

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Liptovský Hrádok, , Slovakia

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Liptovský Mikuláš, , Slovakia

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Luenec, , Slovakia

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Malacky, , Slovakia

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Malacky, , Slovakia

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Martin, , Slovakia

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Michalovce, , Slovakia

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Myjava, , Slovakia

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Námestovo, , Slovakia

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Nitra, , Slovakia

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Nitra, , Slovakia

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Nitra, , Slovakia

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Nové Zámky, , Slovakia

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Piešťany, , Slovakia

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Poprad, , Slovakia

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Povaska Bystrica, , Slovakia

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Považská Bystrica, , Slovakia

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Preov, , Slovakia

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Prievidza, , Slovakia

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Púchov, , Slovakia

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Revúca, , Slovakia

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Rimavská Sobota, , Slovakia

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Ruomberok, , Slovakia

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Ružomberok, , Slovakia

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Senica, , Slovakia

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Skalica, , Slovakia

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Sobrance, , Slovakia

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SpisskaNova Ves, , Slovakia

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Stropkov, , Slovakia

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Svidník, , Slovakia

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Topoany, , Slovakia

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Trebišov, , Slovakia

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Trenčín, , Slovakia

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Trenin, , Slovakia

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Trnava, , Slovakia

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Turianske Teplice, , Slovakia

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Urany, , Slovakia

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Vranov n/Topou, , Slovakia

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Vráble, , Slovakia

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Pfizer Investigational Site

Zvolen, , Slovakia

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Countries

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Slovakia

Other Identifiers

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A0221059

Identifier Type: -

Identifier Source: org_study_id

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