Clinical trial NCT00645281: A Study to Evaluate the Efficacy of Tolterodine on Specific Symptoms in Adult Patients With Overactive Bladder.
Official title: Symptom Specific Effectiveness of Tolterodine ER 4 mg in Patients With Symptoms of Overactive Bladder (OAB) in a Primary Care Setting. A Phase IV, Open-label, Single-arm, Non-randomized, Trial in Adult Patients With OAB.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Bladder, Overactive
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 896
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: The purpose of this study is to evaluate the efficacy and safety of tolterodine in impacting the primary symptom or complaint of patients with OAB.


Eligibility criteria: Inclusion Criteria:

* self-reported symptoms of OAB for ≥ 3 months prior to screening
* OAB as defined by urinary frequency (a minimum of 8 micturitions per 24 hours)
* urgency (defined as a strong and sudden desire to urinate) or urge incontinence a minimum of 2 episodes in 3 days, as confirmed by the micturition diary between screening and baseline
* patients who describe the degree of bothersomeness of their most bothersome OAB symptom as "moderately ", "a great deal ", or "a very great deal" per the OAB Bother Rating Scale

Exclusion Criteria:

* any condition that would contraindicate their usage of tolterodine once daily, including: narrow angle glaucoma, urinary retention, gastric retention
* any clinically significant local urinary tract pathology which could mimic the symptoms of OAB, such as infection or hematuria
* stress incontinence, functional, or overflow incontinence as determined by the investigator
* symptomatic acute urinary tract infection (UTI) during the run-in period, or recurrent UTIs defined by treatment for symptomatic UTI \>3 times in the 12 months prior to participation in this clinical trial
* clinically significant urinary tract obstruction
* history of lower urinary tract surgery (e.g. prostate removal or destruction, incontinence surgery) within the past 3 months
* clinically significant interstitial cystitis or significant bladder pain syndrome

Primary outcomes:
measure: Change from baseline to Week 12 in the micturition bladder diary variable related to the primary symptom of the patient at the time of study entry
timeFrame: 12 weeks
Secondary outcomes:
measure: OAB Bother Rating Scale at baseline
timeFrame: baseline
measure: Change from baseline to Week 4 and 12 in micturition bladder diary variables
timeFrame: 12 weeks
measure: Change from baseline to Week 4 and 12 in Patient's Perception of Bladder Condition
timeFrame: 12 weeks
measure: Change from baseline to Week 4 and 12 in AUA Symptom Index
timeFrame: 12 weeks
measure: Change from baseline to Week 4 and 12 in OAB questionnaire
timeFrame: 12 weeks
measure: Clinical Global Impression-Improvement at Week 12
timeFrame: 12 weeks
measure: Overall Treatment Effect Scale of Overactive Bladder Control at Week 4 and 12
timeFrame: 12 weeks
measure: To asses the safety of tolterodine in patients with OAB
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Montgomery
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Sun Lakes
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Bentonville
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Jonesboro
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Buena Park
country: United States
facility: Pfizer Investigational Site
state: California
city: Foothill Ranch
country: United States
facility: Pfizer Investigational Site
state: California
city: Fresno
country: United States
facility: Pfizer Investigational Site
state: California
city: West Covina
country: United States
facility: Pfizer Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Lakewood
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Chipley
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Davie
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Hallandale Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Murdock
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pembroke Pines
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Saint Cloud
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Barnesville
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Blue Ridge
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Naperville
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Orland Park
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Newton
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Shawnee Mission
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Marrero
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Laurel
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Oxon Hill
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Portage
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Blackwood
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Mount Laurel
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Binghamton
country: United States
facility: Pfizer Investigational Site
state: New York
city: Endicott
country: United States
facility: Pfizer Investigational Site
state: New York
city: Endwell
country: United States
facility: Pfizer Investigational Site
state: New York
city: Kingston
country: United States
facility: Pfizer Investigational Site
state: New York
city: Beaufort
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Morehead City
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Kettering
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Central Point
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Medford
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Bala-Cynwyd
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Bensalem
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Connellsville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Sellersville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Stoneboro
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Warwick
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Greer
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Simpsonville
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Cordova
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Huntingdon
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Lexington
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Savannah
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Selmer
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Waynesboro
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Bryan
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Colleyville
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Friendswood
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Plano
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Plano
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
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: West Jordan
country: United States
facility: Pfizer Investigational Site
state: Utah
city: West Valley City
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: New Berlin
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Oregon
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Wauwatosa
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: