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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00425100
First received: January 19, 2007
Last updated: February 24, 2009
Last verified: February 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Mean Number of Urgency Episodes Per 24 Hours [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425100

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

Additional Information:
No publications provided by Pfizer

Additional 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
Study First Received: January 19, 2007
Results First Received: October 10, 2008
Last Updated: February 24, 2009
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 31, 2014