Clinical trial NCT00798434: 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.
Official title: A 24-Week, Multi-Centre Trial, Comprising A 12-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Phase Followed By A 12-Week Open-Label Phase, To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Elderly Patients With Overactive Bladder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Bladder, Overactive
Keywords: Overactive bladder syndrome
fesoterodine
elderly
flexible dose regimen
urgency
frequency
urge urinary incontinence
anticholinergic
antimuscarinic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-26
Enrollment: 794
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Percent Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Percent Change From Baseline of Severe Micturition-Related Urgency Episodes Per 24 Hours at Weeks 4, 8, and 12
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Change From Baseline in Mean Number of Micturitions Per 24 Hours at Weeks 4, 8, and 12
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Percent Change From Baseline in Micturitions Per 24 Hours at Weeks 4, 8, and 12
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4, 8, and 12
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4, 8, and 12
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Percent Change From Baseline of UUI Episodes Per 24 Hours at Weeks 4, 8, and 12
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Change From Baseline in Daily Sum Rating in USS at Weeks 4, 8, and 12
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Percentage of Participants Who Were Incontinent at Baseline and Became Dry
timeFrame: Weeks 8 to 12
measure: Change From Baseline in Number of Skin Protective Agents Used by Participants at Weeks 4, 8, and 12
timeFrame: Baseline and Weeks 4, 8, and 12
measure: Percentage of Participants With Improvement at Week 12
timeFrame: Week 12
measure: Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4
timeFrame: Baseline and Week 4
measure: Change From Baseline in PPBC at Week 8
timeFrame: Baseline and Week 8
measure: Change From Baseline in PPBC at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in PPBC at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline Patient Perception of Urgency Scale (PPUS) at Week 4
timeFrame: Baseline and Weeks 4
measure: Change From Baseline in PPUS at Week 8
timeFrame: Baseline and Week 8
measure: Change From Baseline in PPUS at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in PPUS at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Symptom/Bother Score at Weeks 4, 8, 12, and 24
timeFrame: Baseline and Weeks 4, 8, 12, and 24
measure: Change From Baseline in Overactive Bladder Satisfaction Questionnaire (OAB-q) Total Score at Weeks 4, 8, 12, and 24
timeFrame: Baseline and Weeks 4, 8, 12, and 24
measure: Change From Baseline in OAB-q Subscale Scores at Weeks 4, 8, 12, and 24
timeFrame: Baseline and Weeks 4, 8, 12, and 24
measure: Change From Week 12 in Overactive Bladder Satisfaction (OAB-S) Scale for Satisfaction With OAB Control at Week 24
timeFrame: Weeks 12 and 24
measure: Change From Week 12 in OAB-S Scale for OAB Medication Expectation at Week 24
timeFrame: Weeks 12 and 24
measure: Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in EQ-5D- Health State Profile Utility Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in EQ-5D- Each Dimension Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Mini Mental State Examination (MMSE) at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
measure: Percentage of Participants With Improvement at Week 24
timeFrame: Pre-baseline and Week 24
measure: Change From Baseline in Number of Micturition-Related Urgency Episodes Per 24 Hours at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Mean Number of UUI Episodes Per 24 Hours at Week 24
timeFrame: Baseline and Week 24
Locations:
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Antwerpen
country: Belgium
facility: Pfizer Investigational Site
city: Edegem
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Kortrijk
country: Belgium
facility: Pfizer Investigational Site
city: Aarhus N
country: Denmark
facility: Pfizer Investigational Site
city: Glostrup
country: Denmark
facility: Pfizer Investigational Site
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Kouvola
country: Finland
facility: Pfizer Investigational Site
city: OYS
country: Finland
facility: Pfizer Investigational Site
city: Tampere
country: Finland
facility: Pfizer Investigational Site
city: Turku
country: Finland
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt
country: Germany
facility: Pfizer Investigational Site
city: Hannover
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Haifa
country: Israel
facility: Pfizer Investigational Site
city: Haifa
country: Israel
facility: Pfizer Investigational Site
city: Jerusalem
country: Israel
facility: Pfizer Investigational Site
city: Foggia
country: Italy
facility: Pfizer Investigational Site
city: Terracina, LT
country: Italy
facility: Pfizer Investigational Site
city: Hamar
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Tonsberg
country: Norway
facility: Pfizer Investigational Site
city: Trondheim
country: Norway
facility: Pfizer Investigational Site
city: Coimbra
country: Portugal
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Galanta
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice - Saca
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Martorell
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Sabadell
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Getafe
country: Spain
facility: Pfizer Investigational Site
state: Madrid
city: Manacor
country: Spain
facility: Pfizer Investigational Site
state: Palma de Mallorca
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Eslov
country: Sweden
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Malmo
country: Sweden
facility: Pfizer Investigational Site
city: Malmo
country: Sweden
facility: Pfizer Investigational Site
city: Norrkoping
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Frauenfeld
country: Switzerland
facility: Pfizer Investigational Site
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Izmir
country: Turkey
facility: Pfizer Investigational Site
city: Samsun
country: Turkey
facility: Pfizer Investigational Site
city: Bexhill on Sea
country: United Kingdom
facility: Pfizer Investigational Site
state: East Sussex
city: Leytonstone
country: United Kingdom
facility: Pfizer Investigational Site
state: London
city: Harrow
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
city: High Heaton
country: United Kingdom
facility: Pfizer Investigational Site
state: Newcastle upon Tyne
city: Birmingham
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.