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.”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: tolterodine extended release
  • Tolterodine ER capsule 4 mg daily for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: tolterodine ER group

Primary Measures

• 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
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• OAB Bother Rating Scale at baseline
  • Time Frame: baseline
    Safety Issue?: No
• Change from baseline to Week 4 and 12 in micturition bladder diary variables
  • Time Frame: 12 weeks
    Safety Issue?: No
• Change from baseline to Week 4 and 12 in Patient's Perception of Bladder Condition
  • Time Frame: 12 weeks
    Safety Issue?: No
• Change from baseline to Week 4 and 12 in AUA Symptom Index
  • Time Frame: 12 weeks
    Safety Issue?: No
• Change from baseline to Week 4 and 12 in OAB questionnaire
  • Time Frame: 12 weeks
    Safety Issue?: No
• Clinical Global Impression-Improvement at Week 12
  • Time Frame: 12 weeks
    Safety Issue?: No
• Overall Treatment Effect Scale of Overactive Bladder Control at Week 4 and 12
  • Time Frame: 12 weeks
    Safety Issue?: No
• To asses the safety of tolterodine in patients with OAB
  • Time Frame: 12 weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00645281

Study ID Number: A6121001

ClinicalTrials.gov Identifier: NCT00645281

Health Authority: United States: Food and Drug Administration

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