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.”

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.

Study Type: Interventional

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

Study Primary Completion Date: October 2007

Intervention(s) in this Clinical Trial

• Drug: fesoterodine fumarate
  • 12 weeks of study treatment: Subjects received fesoterodine tablets 4 mg once daily for 4 weeks; thereafter, daily dosage was maintained at 4 mg or increased to 8 mg based on subject's and physician's subjective assessment of efficacy and tolerability.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Open Label-fesoterodine
  • Single treatment study arm.

Primary Measures

• Mean Number of Micturition Episodes Per 24 Hours
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Mean Number of Urgency Episodes Per 24 Hours
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment
  • Time Frame: Week 12
    Safety Issue?: No

Secondary Measures

• Nocturnal Micturitions Per 24 Hours
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Severe Urgency Episodes Per 24 Hours
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Mean Rating on the Urinary Sensation Scale
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Patient Perception of Bladder Condition (PPBC) Score
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change)
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Urgency Perception Scale (UPS)
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change)
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• "Satisfaction With OAB Control" Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S)
  • Time Frame: Week 12
    Safety Issue?: No
• Sum Rating on the Urinary Sensation Scale
  • Time Frame: Baseline and Week 12
    Safety Issue?: No
• Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis)
  • Time Frame: Week 12
    Safety Issue?: No

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.

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 July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00425100

Study ID Number: A0221007

ClinicalTrials.gov Identifier: NCT00425100

Health Authority: United States: Food and Drug Administration

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org posting.