Clinical trial NCT00546637: Fesoterodine "add-on" Male Overactive Bladder Study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Fesoterodine As An "Add-On" Therapy In Men With Persistent Overactive Bladder Symptoms Under Monotherapy Of Alpha Blocker For Lower Urinary Tract Symptoms.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder Syndrome
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-19
Enrollment: 947
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of fesoterodine on overactive bladder symptom improvement when added to ongoing alpha blocker treatment.


Eligibility criteria: Inclusion Criteria:

* Men aged 40 years and above.
* On a stable and well-tolerated dose of an alpha-blocker prescribed for LUTS for at least 6 weeks prior to screening (Visit 1).
* Persistent symptoms of OAB with urinary frequency \>=8 times/24 hours and micturition-related urgency episodes \>=3 episode/24 hours.

Exclusion Criteria:

* Contraindication to fesoterodine (antimuscarinics).
* Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.
* Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.

Primary outcomes:
measure: Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Numerical Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4
timeFrame: Baseline, Week 4
measure: Percentage Change From Baseline in Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Numerical Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Percentage Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Numerical Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Numerical Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and Week 12
measure: Percentage Change From Baseline in UUI Episodes Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Numerical Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Percentage Change From Baseline in Severe Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Numerical Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Percentage Change From Baseline in Nocturnal Micturition-Related Urgency Episodes Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Numerical Change From Baseline in Urinary Sensation Scale (USS) Sum Rating Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Change From Baseline in International Prostate Symptom Score (IPSS) Total Score (Sum Question 1 [Q1] to Q7) Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Change From Baseline in IPSS Storage Domain (Sum Q2, Q4, and Q7) Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Change From Baseline in IPSS Voiding Domain (Sum Q1, Q3, Q5, and Q6) Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Change From Baseline in IPSS Quality of Life (QoL) Score (Q8) Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Change From Baseline in IPSS Individual Item Scores (Q1, Q2, Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in IPSS Individual Item Scores (Q1, Q2,Q3, Q4, Q5, Q6, and Q7) Per 24 Hours at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) Per 24 Hours at Week 4
timeFrame: Baseline, Week 4
measure: Number of Participants With Change From Baseline in PPBC Per 24 Hours at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants With Change From Baseline in Urgency Perception Scale (UPS) Per 24 Hours at Week 4
timeFrame: Baseline, Week 4
measure: Number of Participants With Change From Baseline in Change From Baseline in UPS Per 24 Hours at Week 12.
timeFrame: Baseline, Week 12
measure: Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Per 24 Hours at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Change From Baseline in Total Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12
timeFrame: Baseline, Week 4 and 12
measure: Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Concern Domain)
timeFrame: Baseline, Week 4 and 12
measure: Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Coping Domain)
timeFrame: Baseline, Week 4 and Week 12
measure: Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Sleep Domain)
timeFrame: Baseline, Week 4 and Week 12
measure: Change From Baseline in Score of Each Health Related Quality of Life (HRQL) Domain of OAB-q at Week 4 and 12 (OAB-q Social Interaction Domain)
timeFrame: Baseline, Week 4 and Week 12
measure: Change From Baseline in Post Void Residual (PVR) Urine Volume Per 24 Hours at Week 4, 8 and 12
timeFrame: Baseline, Week 4, 8 and 12
measure: Change From Baseline in Maximum Urinary Flow Rate (QMAX) Per 24 Hours at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants Reporting Urinary Retention Requiring Catheterization (All Causalities)
timeFrame: Baseline, Week 12
measure: Number of Participants Experiencing Adverse Events Related to Increased Voiding Difficulty (All Causalities)
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Gilbert
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Gilbert
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Litchfield Park
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Mesa
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: La Mesa
country: United States
facility: Pfizer Investigational Site
state: California
city: Newport Beach
country: United States
facility: Pfizer Investigational Site
state: California
city: San Bernardino
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Jupiter
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orange City
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Dunwoody
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Jeffersonville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Newburgh
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Des Moines
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Iowa City
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Owings Mills
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Watertown
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Flint
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: St. Clair Shores
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Troy
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Utica
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: West Bloomfield
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: West Bloomfield
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Sewell
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Albany
country: United States
facility: Pfizer Investigational Site
state: New York
city: Garden City
country: United States
facility: Pfizer Investigational Site
state: New York
city: Kingston
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Poughkeepsie
country: United States
facility: Pfizer Investigational Site
state: New York
city: Syracuse
country: United States
facility: Pfizer Investigational Site
state: New York
city: Williamsville
country: United States
facility: Pfizer Investigational Site
state: New York
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Fargo
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Fargo
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Bethany
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Bala Cynwyd
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Camp Hill
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Greer
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Antwerpen
country: Belgium
facility: Pfizer Investigational Site
city: Edegem
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Salvador
country: Brazil
facility: Pfizer Investigational Site
state: BA
city: Curitiba
country: Brazil
facility: Pfizer Investigational Site
state: PR
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Campos do Jordão
country: Brazil
facility: Pfizer Investigational Site
state: São Paulo
city: Victoria
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Barrie
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: North Bay
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Chicoutimi
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Medellin
country: Colombia
facility: Pfizer Investigational Site
state: Antioquia
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt
country: Germany
facility: Pfizer Investigational Site
city: Goettingen
country: Germany
facility: Pfizer Investigational Site
city: Hagenow
country: Germany
facility: Pfizer Investigational Site
city: Lauenburg
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Oberursel
country: Germany
facility: Pfizer Investigational Site
city: Wiesbaden
country: Germany
facility: Pfizer Investigational Site
city: Ioannina
country: Greece
facility: Pfizer Investigational Site
state: Ipiros
city: Patras
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Ludhiana
country: India
facility: Pfizer Investigational Site
state: Punjab
city: Lucknow
country: India
facility: Pfizer Investigational Site
state: Uttar Pradesh
city: Lucknow
country: India
facility: Pfizer Investigational Site
state: Uttar Pradesh
city: New Delhi
country: India
facility: Pfizer Investigational Site
city: Bucheon-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyunggi-do
city: Pusan
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Kuching
country: Malaysia
facility: Pfizer Investigational Site
state: Sarawak
city: Kuching
country: Malaysia
facility: Pfizer Investigational Site
state: Sarawak
city: Roermond
country: Netherlands
facility: Pfizer Investigational Site
city: Tilburg
country: Netherlands
facility: Pfizer Investigational Site
city: Zutphen
country: Netherlands
facility: Pfizer Investigational Site
city: Bodø
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Cebu City
country: Philippines
facility: Pfizer Investigational Site
state: Cebu
city: Bacolod City
country: Philippines
facility: Pfizer Investigational Site
city: Makati City
country: Philippines
facility: Pfizer Investigational Site
city: Manila
country: Philippines
facility: Pfizer Investigational Site
city: Manila
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Bialystok
country: Poland
facility: Pfizer Investigational Site
city: Gdansk
country: Poland
facility: Pfizer Investigational Site
city: Gdansk
country: Poland
facility: Pfizer Investigational Site
city: Lodz
country: Poland
facility: Pfizer Investigational Site
city: Myslowice
country: Poland
facility: Pfizer Investigational Site
city: Wroclaw
country: Poland
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Banska Bystrica
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Martin
country: Slovakia
facility: Pfizer Investigational Site
city: Piestany
country: Slovakia
facility: Pfizer Investigational Site
city: Skalica
country: Slovakia
facility: Pfizer Investigational Site
city: Martorell
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: Boras
country: Sweden
facility: Pfizer Investigational Site
city: Jonkoping
country: Sweden
facility: Pfizer Investigational Site
city: Skovde
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Ratchathewi
country: Thailand
facility: Pfizer Investigational Site
state: Bangkok
city: Amphoe Mueang
country: Thailand
facility: Pfizer Investigational Site
state: Chiang Mai
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: