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.

NCT00798434 | Completed Phase 4 Results

• 1 other identifier: A0221045
• Study Type: interventional
• Target: 794
• Locations: 15 countries
• Sites: 60

Brief Summary

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.

Conditions

Urinary Bladder, Overactive

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12

  Number of micturition-related urgency episodes per 24 hours calculated as number of micturitions with USS rating of greater than or equal to (\>=) 3 divided by number of days that diary data was collected at that visit. USS ranged 1 to 5 (1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine). Change = observation minus baseline, where lower scores were an improvement/decrease in micturition-related urgency episodes.

  Baseline and Week 12

Secondary Outcomes (30)

• Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12

  Baseline and Weeks 4, 8, and 12

• Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12

  Baseline and Weeks 4, 8, and 12

• Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12

  Baseline and Weeks 4, 8, and 12

• Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12

  Baseline and Weeks 4, 8, and 12

• Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12

  Baseline and Weeks 4, 8, and 12

Other Outcomes (6)

• Percentage of Participants With Improvement at Week 24

  Pre-baseline and Week 24

• Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 24

  Baseline and Week 24

• Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 24

  Baseline and Week 24

Study Arms (2)

Placebo

ACTIVE COMPARATOR

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.

Drug: Placebo

Fesoterodine

ACTIVE COMPARATOR

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.

Drug: Fesoterodine fumarate

Interventions

Placebo DRUG

placebo administered orally in the morning or evening.

Placebo

Fesoterodine fumarate DRUG

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

Also known as: Toviaz

Fesoterodine

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (60)

Pfizer Investigational Site

Vienna, 1090, Austria

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Antwerp, 2060, Belgium

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Edegem, B-2650, Belgium

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Ghent, B-9000, Belgium

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Kortrijk, 8500, Belgium

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Aarhus N, 8200, Denmark

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Glostrup Municipality, 2600, Denmark

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Helsinki, 00290, Finland

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Kouvola, 45200, Finland

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OYS, 90029, Finland

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Tampere, 33521, Finland

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Turku, 20100, Finland

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Berlin, 10249, Germany

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Berlin, 14052, Germany

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Frankfurt, 60435, Germany

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Hanover, 30625, Germany

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Leipzig, 04109, Germany

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München, 81927, Germany

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Haifa, 31096, Israel

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Haifa, 34362, Israel

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Jerusalem, 91031, Israel

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Foggia, 71100, Italy

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Terracina, LT, 04019, Italy

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Hamar, 2317, Norway

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Oslo, NO-0257, Norway

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Trondheim, 7006, Norway

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Tønsberg, 3103, Norway

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Coimbra, 3000-075, Portugal

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Lisbon, 1990-273, Portugal

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Porto, 4050-011, Portugal

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Porto, 4099-005, Portugal

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Porto, 4200-319, Portugal

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Bratislava, 851 01, Slovakia

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Bratislava, 851 05, Slovakia

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Galanta, 924 22, Slovakia

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Kosice - Saca, 040 15, Slovakia

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Košice, 040 11, Slovakia

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Martorell, Barcelona, 08760, Spain

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Sabadell, Barcelona, 08208, Spain

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Getafe, Madrid, 28905, Spain

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Manacor, Palma de Mallorca, 07500, Spain

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Valencia, Valencia, 46009, Spain

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Eslöv, 241 23, Sweden

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Gothenburg, 416 85, Sweden

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Malmo, 211 20, Sweden

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Malmo, 211 52, Sweden

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Norrköping, 601 82, Sweden

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Stockholm, 141 86, Sweden

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Frauenfeld, CH-8501, Switzerland

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Ankara, 06100, Turkey (Türkiye)

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Istanbul, 34098, Turkey (Türkiye)

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Izmir, 35100, Turkey (Türkiye)

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Samsun, 55200, Turkey (Türkiye)

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Bexhill-on-Sea, East Sussex, TN39 4SP, United Kingdom

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Leytonstone, London, E11 1NR, United Kingdom

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Harrow, Middlesex, HA1 3UJ, United Kingdom

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High Heaton, Newcastle upon Tyne, NE7 7DN, United Kingdom

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Birmingham, B17 0AA, United Kingdom

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London, W2 1NY, United Kingdom

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London, WC1E 6AU, United Kingdom

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Related Publications (2)

• 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.

  PMID: 37160401 DERIVED

• 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.

  PMID: 23460503 DERIVED

Related Links

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

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Interventions

fesoterodine

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Limitations and Caveats

The descriptive statistics and analyses of outcome measure 12 as defined in the protocol are not presented. Results are presented as defined in the statistical analysis plan.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2008
• First Posted: November 26, 2008
• Study Start: June 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: December 14, 2011
• Results First Posted: December 14, 2011

Record last verified: 2011-11

Locations

AU (1); DE (6); FI (5); IL (3); NO (4); PT (5); SE (6); BE (4); GB (7); IT (2); DK (2); CH (1); TU (4); SL (5); ES (5)