Clinical trial NCT00425100: A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients
Official title: A 12-Week, Multicenter, Open-Label, Single-Arm Study To Evaluate The Effects Of Fesoterodine On Treatment Satisfaction And Symptom Relief In Overactive Bladder Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-22
Enrollment: 516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB) symptom relief in OAB patients who were dissatisfied with their prior therapy with tolterodine.


Eligibility criteria: Inclusion Criteria:

* OAB patients who present with OAB symptoms(≥8 micturitions and ≥3 urgency episodes per 24 h documented in the baseline bladder diary)
* OAB patients dissatisfied with their prior therapy with tolterodine

Exclusion Criteria:

* Patients with any contraindication to fesoterodine usage, e.g., urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, or known hypersensitivity to the drug or its ingredients.
* Patients with significant hepatic and renal disease or other significant unstable diseases.
* OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.

Primary outcomes:
measure: Mean Number of Micturition Episodes Per 24 Hours
timeFrame: Baseline and Week 12
measure: Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
timeFrame: Baseline and Week 12
measure: Mean Number of Urgency Episodes Per 24 Hours
timeFrame: Baseline and Week 12
measure: Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment
timeFrame: Week 12
Secondary outcomes:
measure: Nocturnal Micturitions Per 24 Hours
timeFrame: Baseline and Week 12
measure: Severe Urgency Episodes Per 24 Hours
timeFrame: Baseline and Week 12
measure: Mean Rating on the Urinary Sensation Scale
timeFrame: Baseline and Week 12
measure: Patient Perception of Bladder Condition (PPBC) Score
timeFrame: Baseline and Week 12
measure: Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change)
timeFrame: Baseline and Week 12
measure: Urgency Perception Scale (UPS)
timeFrame: Baseline and Week 12
measure: Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change)
timeFrame: Baseline and Week 12
measure: Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain
timeFrame: Baseline and Week 12
measure: Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain
timeFrame: Baseline and Week 12
measure: Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain
timeFrame: Baseline and Week 12
measure: Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain
timeFrame: Baseline and Week 12
measure: Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale
timeFrame: Baseline and Week 12
measure: Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale
timeFrame: Baseline and Week 12
measure: "Satisfaction With OAB Control" Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S)
timeFrame: Week 12
measure: Sum Rating on the Urinary Sensation Scale
timeFrame: Baseline and Week 12
measure: Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis)
timeFrame: Week 12
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: La Mesa
country: United States
facility: Pfizer Investigational Site
state: California
city: Orangevale
country: United States
facility: Pfizer Investigational Site
state: California
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Aurora
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Pratt
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Milford
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Westampton
country: United States
facility: Pfizer Investigational Site
state: New Jersey
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: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Bethany
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Sellersville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Edegem
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Jette
country: Belgium
facility: Pfizer Investigational Site
city: Turnhout
country: Belgium
facility: Pfizer Investigational Site
city: Alajuela Centro
country: Costa Rica
facility: Pfizer Investigational Site
state: Alajuela
city: San Jose
country: Costa Rica
facility: Pfizer Investigational Site
city: Brno-Bohunice
country: Czechia
facility: Pfizer Investigational Site
city: Hradec Kralove
country: Czechia
facility: Pfizer Investigational Site
city: Praha 2
country: Czechia
facility: Pfizer Investigational Site
city: Praha 5
country: Czechia
facility: Pfizer Investigational Site
city: Alzey
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Duisburg
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt
country: Germany
facility: Pfizer Investigational Site
city: Marburg
country: Germany
facility: Pfizer Investigational Site
city: Muelheim A.d. Ruhr
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Bucheon-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyunggi-do
city: Busan
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Daejeon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Jeonnam
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: Lodz
country: Poland
facility: Pfizer Investigational Site
city: Myslowice
country: Poland
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Malacky
country: Slovakia
facility: Pfizer Investigational Site
city: Piestany
country: Slovakia
facility: Pfizer Investigational Site
city: Presov
country: Slovakia
facility: Pfizer Investigational Site
city: Skalica
country: Slovakia
facility: Pfizer Investigational Site
city: Chernivtsi
country: Ukraine
facility: Pfizer Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Pfizer Investigational Site
city: Kharkiv
country: Ukraine
facility: Pfizer Investigational Site
city: Odessa
country: Ukraine
facility: Pfizer Investigational Site
city: Zaporizhzhia
country: Ukraine
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Wyndaele JJ, Goldfischer ER, Morrow JD, Gong J, Tseng LJ, Guan Z, Choo MS. Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study. Int J Clin Pract. 2009 Apr;63(4):560-7. doi: 10.1111/j.1742-1241.2009.02035.x.