A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00928070

Purpose

This study is designed to assess the efficacy and safety of a flexible dose regimen of fesoterodine on urgency urinary incontinence (UUI) episodes in vulnerable elderly subjects with overactive bladder (OAB).

Condition	Intervention	Phase
Overactive Bladder	Drug: Fesoterodine Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine Flexible Dose Regimen In Vulnerable Elderly Patients With Overactive Bladder.

Resource links provided by NLM:

MedlinePlus related topics: Urinary Incontinence

Drug Information available for: Fesoterodine Fesoterodine fumarate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change in mean number of urgency urinary incontinence (UUI) episodes per 24 hours at Week 12 relative to baseline (defined as those micturitions with Urinary Sensation Scale rating of 5 in the diary) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bladder Diary [ Time Frame: 4 and 12 weeks ] [ Designated as safety issue: No ]
Protective Undergarment Usage [ Time Frame: 4 and 12 weeks ] [ Designated as safety issue: No ]
PROs (PPBC, OAB-q, OAB-S) [ Time Frame: 4 and/or 12 weeks ] [ Designated as safety issue: No ]
Cognition Assessment (MMSE) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
PVR [ Time Frame: 4 and 12 weeks ] [ Designated as safety issue: Yes ]
Safety Evaluations [ Time Frame: 4,8, and 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	610
Study Start Date:	September 2009
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Fesoterodine: Experimental	Drug: Fesoterodine Fesoterodine 4 mg and 8 mg
Placebo: Placebo Comparator	Drug: Placebo Placebo sham 4 mg and 8 mg

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

male or female subjects 65 years of age or older
OAB symptoms for at least 3 months
score 3 or greater on Vulnerable Elderly Survey (VES-13)
adequate mobility for independent toileting
mean number of at least 2 UUI episodes per 24 hours
mean urinary frequency of 8 or more micturitions per 24 hours
able to independently complete the bladder diaries

Exclusion Criteria:

PVR urinary volume greater than 200 ml
MMSE score less than 20
greater than 15 UUI episodes per 24 hours

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928070

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 78 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

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0221049
Study First Received:	June 24, 2009
Last Updated:	February 4, 2010
ClinicalTrials.gov Identifier:	NCT00928070 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Urgency Urinary Incontinence OAB

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on February 08, 2010