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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00425100

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 III

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

Drug Information available for: Fesoterodine Fesoterodine fumarate

U.S. FDA Resources

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
Open Label-fesoterodine: Experimental 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

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org posting. This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Wyndaele JJ, Goldfischer ER, Morrow JD, Gong J, Tseng LJ, Guan Z, Choo MS. Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study. Int J Clin Pract. 2009 Apr;63(4):560-7.

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0221007
Study First Received:	January 19, 2007
Results First Received:	October 10, 2008
Last Updated:	February 24, 2009
ClinicalTrials.gov Identifier:	NCT00425100 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Cystocele
Urologic Diseases
Urinary Bladder Diseases

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Urinary Bladder, Overactive
Urologic Diseases
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on September 02, 2009