We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00425100
Recruitment Status : Completed
First Posted : January 22, 2007
Results First Posted : February 10, 2009
Last Update Posted : March 23, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: fesoterodine fumarate Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 516 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2007
Primary Completion Date : October 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Open Label-fesoterodine
Single treatment study arm.
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.


Outcome Measures

Primary Outcome Measures :
  1. Mean Number of Micturition Episodes Per 24 Hours [ Time Frame: Baseline and Week 12 ]
  2. Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours [ Time Frame: Baseline and Week 12 ]
  3. Mean Number of Urgency Episodes Per 24 Hours [ Time Frame: Baseline and Week 12 ]
  4. Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Nocturnal Micturitions Per 24 Hours [ Time Frame: Baseline and Week 12 ]
  2. Severe Urgency Episodes Per 24 Hours [ Time Frame: Baseline and Week 12 ]
  3. Mean Rating on the Urinary Sensation Scale [ Time Frame: Baseline and Week 12 ]
  4. Patient Perception of Bladder Condition (PPBC) Score [ Time Frame: Baseline and Week 12 ]
  5. Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change) [ Time Frame: Baseline and Week 12 ]
  6. Urgency Perception Scale (UPS) [ Time Frame: Baseline and Week 12 ]
  7. Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change) [ Time Frame: Baseline and Week 12 ]
  8. Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain [ Time Frame: Baseline and Week 12 ]
  9. Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain [ Time Frame: Baseline and Week 12 ]
  10. Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain [ Time Frame: Baseline and Week 12 ]
  11. Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain [ Time Frame: Baseline and Week 12 ]
  12. Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale [ Time Frame: Baseline and Week 12 ]
  13. Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale [ Time Frame: Baseline and Week 12 ]
  14. "Satisfaction With OAB Control" Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S) [ Time Frame: Week 12 ]
  15. Sum Rating on the Urinary Sensation Scale [ Time Frame: Baseline and Week 12 ]
  16. Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis) [ Time Frame: Week 12 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00425100


  Show 60 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00425100     History of Changes
Other Study ID Numbers: A0221007
First Posted: January 22, 2007    Key Record Dates
Results First Posted: February 10, 2009
Last Update Posted: March 23, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Fesoterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents