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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00425100
First Posted: January 22, 2007
Last Update Posted: March 23, 2009
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.
Information provided by:
Pfizer
  Purpose
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 Intervention Phase
Overactive Bladder Drug: fesoterodine fumarate Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

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

Enrollment: 516
Study Start Date: January 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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


  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Homewood, Alabama, United States, 35209
Pfizer Investigational Site
Huntsville, Alabama, United States, 35801
United States, California
Pfizer Investigational Site
La Mesa, California, United States, 91942
Pfizer Investigational Site
Orangevale, California, United States, 95662
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80012
United States, Florida
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33407
United States, Illinois
Pfizer Investigational Site
Aurora, Illinois, United States, 60504
United States, Kansas
Pfizer Investigational Site
Pratt, Kansas, United States, 67124
United States, Louisiana
Pfizer Investigational Site
Shrevport, Louisiana, United States, 71106
United States, Massachusetts
Pfizer Investigational Site
Milford, Massachusetts, United States, 01757
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68114
United States, New Jersey
Pfizer Investigational Site
Westampton, New Jersey, United States, 08060
United States, New York
Pfizer Investigational Site
Kingston, New York, United States, 12401
Pfizer Investigational Site
New York, New York, United States, 10016
Pfizer Investigational Site
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45212
United States, Oklahoma
Pfizer Investigational Site
Bethany, Oklahoma, United States, 73008
United States, Oregon
Pfizer Investigational Site
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Pfizer Investigational Site
Sellersville, Pennsylvania, United States, 18960
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77024
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84107
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84124
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53209
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1200
Pfizer Investigational Site
Edegem, Belgium, B-2650
Pfizer Investigational Site
Gent, Belgium, B-9000
Pfizer Investigational Site
Jette, Belgium, B-1090
Pfizer Investigational Site
Turnhout, Belgium, B-2300
Costa Rica
Pfizer Investigational Site
Alajuela Centro, Alajuela, Costa Rica
Pfizer Investigational Site
San Jose, Costa Rica
Czech Republic
Pfizer Investigational Site
Brno-Bohunice, Czech Republic, 625 00
Pfizer Investigational Site
Hradec Kralove, Czech Republic, 500 05
Pfizer Investigational Site
Praha 2, Czech Republic, 128 08
Pfizer Investigational Site
Praha 5, Czech Republic, 152 00
Germany
Pfizer Investigational Site
Alzey, Germany, 55232
Pfizer Investigational Site
Berlin, Germany, 13347
Pfizer Investigational Site
Duisburg, Germany, 47179
Pfizer Investigational Site
Frankfurt, Germany, 65929
Pfizer Investigational Site
Marburg, Germany, 35039
Pfizer Investigational Site
Muelheim a.d. Ruhr, Germany, 45468
Pfizer Investigational Site
Muenchen, Germany, 81925
Korea, Republic of
Pfizer Investigational Site
Bucheon-si, Gyunggi-do, Korea, Republic of, 420-767
Pfizer Investigational Site
Busan, Korea, Republic of, 602-739
Pfizer Investigational Site
Daejeon, Korea, Republic of, 301-721
Pfizer Investigational Site
Jeonnam, Korea, Republic of, 519-809
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-710
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Poland
Pfizer Investigational Site
Lodz, Poland, 93-316
Pfizer Investigational Site
Myslowice, Poland, 41-400
Slovakia
Pfizer Investigational Site
Bratislava, Slovakia, 833 05
Pfizer Investigational Site
Malacky, Slovakia, 901 01
Pfizer Investigational Site
Piestany, Slovakia, 921 01
Pfizer Investigational Site
Presov, Slovakia, 080 01
Pfizer Investigational Site
Skalica, Slovakia, 909 82
Ukraine
Pfizer Investigational Site
Chernivtsi, Ukraine, 58002
Pfizer Investigational Site
Dnipropetrovsk, Ukraine, 49005
Pfizer Investigational Site
Kharkiv, Ukraine, 61037
Pfizer Investigational Site
Odessa, Ukraine, 65000
Pfizer Investigational Site
Zaporizhzhia, Ukraine, 69000
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 Submitted: January 19, 2007
First Posted: January 22, 2007
Results First Submitted: October 10, 2008
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