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A Study to Compare the Effectiveness and Safety of Fesoterodine and Placebo in an Elderly Population of Patients Who go to the Toilet Very Frequently Due to Overactive Bladder.

NCT ID: NCT00798434

Last Updated: 2011-12-14

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

Clinical Phase

PHASE4

Total Enrollment

794 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-09-30

Brief Summary

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The drug being studied, fesoterodine fumarate helps prevent the bladder neck opening at unwanted times and has been shown to help patients with overactive bladder syndrome pass urine less frequently than before treatment. It is postulated that this drug will also prove effective in elderly patients (aged \> 65 years) and that the ability to change dose between 4 and 8mg will allow each patient to have an optimised treatment.

Detailed Description

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Conditions

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Urinary Bladder, Overactive

Keywords

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Overactive bladder syndrome fesoterodine elderly flexible dose regimen urgency frequency urge urinary incontinence anticholinergic antimuscarinic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Flexible dose regimen of placebo once daily. The dose can be increased after 4 weeks if clinically indicated. Subsequently the dose can be reduced to the original dose if clinically indicated.

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

placebo administered orally in the morning or evening.

Fesoterodine

Flexible dose regimen of fesoterodine fumarate 4mg once daily. The dose can be increased to 8mg once daily after 4 weeks if clinically indicated. Subsequently the dose can be reduced to 4mg if clinically indicated.

Group Type ACTIVE_COMPARATOR

Fesoterodine fumarate

Intervention Type DRUG

Fesoterodine fumarate is an antimuscarinic drug recently approved by the European Medicines Evaluation Agency for treatment of symptoms of overactive bladder syndrome.

Interventions

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Placebo

placebo administered orally in the morning or evening.

Intervention Type DRUG

Fesoterodine fumarate

Fesoterodine fumarate is an antimuscarinic drug recently approved by the European Medicines Evaluation Agency for treatment of symptoms of overactive bladder syndrome.

Intervention Type DRUG

Other Intervention Names

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Toviaz

Eligibility Criteria

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Inclusion Criteria

* Male or female ≥65 years old.
* Overactive bladder symptoms for at least 3 months prior to study start.
* Eight or more micturitions per 24 hours as confirmed by diary records

Exclusion Criteria

* Predominant Stress Urinary Incontinence
* Active or recurrent bladder infections
* Other bladder and genital conditions that could be the predominant cause of symptoms or interfere with treatment assessment and success.
Minimum Eligible Age

65 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

Vienna, , Austria

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Antwerp, , Belgium

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Edegem, , Belgium

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Ghent, , Belgium

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Kortrijk, , Belgium

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Aarhus N, , Denmark

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Glostrup Municipality, , Denmark

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Helsinki, , Finland

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Kouvola, , Finland

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OYS, , Finland

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Tampere, , Finland

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Turku, , Finland

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Berlin, , Germany

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Berlin, , Germany

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Frankfurt, , Germany

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Hanover, , Germany

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Leipzig, , Germany

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München, , Germany

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Haifa, , Israel

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Haifa, , Israel

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Jerusalem, , Israel

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Foggia, , Italy

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Terracina, LT, , Italy

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Hamar, , Norway

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Oslo, , Norway

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Trondheim, , Norway

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Tønsberg, , Norway

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Coimbra, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Porto, , Portugal

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Porto, , Portugal

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Galanta, , Slovakia

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Kosice - Saca, , Slovakia

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Košice, , Slovakia

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Martorell, Barcelona, Spain

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Sabadell, Barcelona, Spain

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Getafe, Madrid, Spain

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Manacor, Palma de Mallorca, Spain

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Valencia, Valencia, Spain

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Eslöv, , Sweden

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Gothenburg, , Sweden

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Malmo, , Sweden

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Malmo, , Sweden

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Norrköping, , Sweden

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Stockholm, , Sweden

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Frauenfeld, , Switzerland

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Ankara, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Samsun, , Turkey (Türkiye)

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Bexhill-on-Sea, East Sussex, United Kingdom

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Leytonstone, London, United Kingdom

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Harrow, Middlesex, United Kingdom

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High Heaton, Newcastle upon Tyne, United Kingdom

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Birmingham, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Countries

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Austria Belgium Denmark Finland Germany Israel Italy Norway Portugal Slovakia Spain Sweden Switzerland Turkey (Türkiye) United Kingdom

References

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Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

Reference Type DERIVED
PMID: 37160401 (View on PubMed)

Wagg A, Khullar V, Michel MC, Oelke M, Darekar A, Bitoun CE. Long-term safety, tolerability and efficacy of flexible-dose fesoterodine in elderly patients with overactive bladder: open-label extension of the SOFIA trial. Neurourol Urodyn. 2014 Jan;33(1):106-14. doi: 10.1002/nau.22383. Epub 2013 Mar 4.

Reference Type DERIVED
PMID: 23460503 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221045&StudyName=A%20study%20to%20compare%20the%20effectiveness%20and%20safety%20of%20fesoterodine%20and%20placebo%20in%20an%20elderly%20population%20of%20patients%20who%20go%20to%20the%20toi

To obtain contact information for a study center near you, click here.

Other Identifiers

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A0221045

Identifier Type: -

Identifier Source: org_study_id